[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15616BR\nJob Posting Title Feasibility & Patient Recruitment Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen\u2019s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Advanced Degree preferred\n- Excellent communication, organizational, and interpersonal skills\n- Ability to plan and work on projects with minimal supervision\n- Effective at working with colleagues from all departments and organizational levels while meeting commitments.\n- Experience working as a member of global drug development teams preferred\n- Previous management experience of direct reports or clinical projects\nProven experience in a pharmaceutical environment\n- Good experience of biopharmaceutical clinical research\n- Experience involving a broad exposure to biopharmaceutical clinical development process and procedures\n- Experience developing and implementing recruitment and retention plans\n- Experience working independently across departments within a team/matrix environment\n-Detailed knowledge of international clinical research and drug development\n- Strong understanding of program and study operations in an international setting\n-Relevant therapeutic area(s)\n- Strong computer literacy, including word processing, presentation, spreadsheet and project management applications\n- Organizational change management process", "date_new": "2012-05-21 18:12:39", "url": "http://www.amgen.jobs/xml/28833051/job", "country": "United States", "company": "Amgen", "title": "Feasibility & Patient Recruitment Mgr", "reqid": "15616BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833051}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15775BR\nJob Posting Title Executive Medical Director Global Development - Neurology\nCareer Category Clinical Development\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The neuroscience group is looking for a Global Development Leader to serve as co-lead on a multidisciplinary strategy team for a neuroscience product. This position will be located in Thousand Oaks, California.\n\nThe ideal candidate will represent the unified global medical voice and be the single point of accountability for evidence generation and scientific communication. The candidate will also be responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate broad medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs.\n\nKey Activities include the following:\n\nScientific\n- Oversee activities related to planning for studies across the product lifecycle\n- Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the overall program strategy\n- Provide input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups\n- Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, clinical study reports, publications and reimbursement submissions)\n- Provide strategic medical input into all aspects of the Commercialization process (pre-clinical through launch)\n- Approve medical/scientific components of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs\n- Communicate current safety and efficacy/effectiveness status of the product internally and externally\n- Review, approve, and execute publication plan\n- Provide medical support for licensing activities and support partner relationships\n\nLeadership, Collaboration and Management\n- Co-lead multidisciplinary product strategy team with the Global Commercial Leader\n- Co-author Global Strategic Plan\n- Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions\n- Mentor, coach, and oversee the performance of direct reports\n- Provide oversight and ensure alignment between clinical development and development operations.\n- Provide medical/scientific support to other functions as appropriate\n- Support regional needs for medical/scientific evidence generation\n- Develop key relationships with global opinion leaders\n\nKnowledge\n\n- Proven success in development and execution of clinical trials\n- Excellent knowledge of disease states in therapeutic area\n- Familiar with investigators or institutions in therapeutic area\n- Knowledge of regulatory affairs and drug safety\n- Proven track record in publications\n- Proven track record in commercialization and business practices\n- Documented success leading, managing and motivating staff in a complex, multi-functional matrix environment\nBasic Qualifications MD\n\u2022 Five (5) or more years of either industry or academic research experience\n\u2022 Previous management experience\nPreferred Qualifications Preferred Qualifications\n\u2022 MD plus accredited residency in relevant sub-specialty (ie, Neurology), board certified\n\u2022 Eight (8) or more years of either industry or academic research experience\n\u2022 Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n\u2022 Clinical research experience with Migraine programs", "date_new": "2012-05-21 18:11:47", "url": "http://www.amgen.jobs/xml/28833024/job", "country": "United States", "company": "Amgen", "title": "Executive Medical Director Global Development - Neurology", "reqid": "15775BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833024}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15718BR\nJob Posting Title Clinical Operations Manager\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nField Based\nAmgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification\nand site selection\nStrategically plans and coordinates Amgen sponsored trials (forecasting,\nresourcing, timelines, baseline recruitment)\nAdapt ICF to local requirements\nDefines study specific processes including study communication plans\nEnsures all study staff understand study deliverables and timelines\nTracks local trial implementation, data collection and study reporting\nReviews and approves monitoring reports and Site Initiation Packages (SIPs)\nResponsible with Medical staff for vendor selection and performance evaluation for\nlocal studies, including HE studies (services other than FSP)\nProvides regular updates on study progress to DOM and study sponsors as\nrequired, identifying barriers to site activation and patient enrollment and identifying\npotential solutions\nEnsures quality of study execution\nEscalates study-related issues\nProvides Amgen presence at investigator meetings / key visits\nCoordinate & actively participate at local investigators meetings\nReview GCA Site audit reports and work in conjunction with FSP staff and Site staff\nas required to fix issues\nKey interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up\nProject manages local clinical study teams\nCoordinates SACOM tasks, according to the COM-SACOM RASCI, when those are\nallocated to support COMs in the oversight of operational activities related to\nplanning, executing and reporting of phase 3 / 4 studies\nSingle point of contact at a project level for LOC staff and GSM\nPartners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs)\nIdentifies and highlights risk areas (concerning operational readiness,\ncommunication and management)\nEnsures CRA receives necessary TA-related and study-related training\nCoordinates local study-related administrative tasks e.g. information to finance,\nstatus update to BU, status updates in local meetings\nActively participates in the regional COM network as required\nParticipate in the hub or country level Functional Management Team (FMT Governance)\nBasic Qualifications BA/BS/BSC or qualified nurse (RN)\nwork experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained\nworking on clinical trials in a biotech, pharmaceutical or CRO company or other relevant clinical setting)\nPreferred Qualifications Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company\nClinical trial management experience\nOperational performance measurement experience\nInternational collaboration experience", "date_new": "2012-05-21 18:11:05", "url": "http://www.amgen.jobs/xml/28832994/job", "country": "Netherlands", "company": "Amgen", "title": "Clinical Operations Manager", "reqid": "15718BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28832994}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15617BR\nJob Posting Title Feasibility & Patient Recruitment Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Manager, Feasibility & Patient recruitment will establish strategies and decision making processes to address the barriers in reaching goals around feasibility and identifying and recruiting appropriate patient populations within established timelines. There are many responsibilities associated with this role key to ensuring the timely and effective delivery of Amgen\u2019s strategy to its stakeholders including: setting project timelines and priorities based on study objectives and ongoing assignments; organizing and leading cross-functional meetings to develop and execute the enrollment forecasting strategies for our programs; identifying patient profiles, patient market dynamics, potential recruitment barriers, regional recruitment boundaries, triggers, contingency plans and implementation plans by country and site. Additionally, this individual will serve as a consultant and advisor to study teams and regions to help them maximize their enrollment rates. He/She will also gather historic regional performance data, track and report successes of various recruitment strategies and manage the inventory of recruitment tools and recruitment vendors and communicate best practices to teams and site management staff ensuring accurate and timely information exchange between departments. Also critical to the success of this role, will be maintaining therapeutic knowledge of Amgen products; knowledge of performance measurement at a departmental level and a fundamental understanding of the organizational change management process.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Preferred Qualifications - Advanced Degree preferred\n- Excellent communication, organizational, and interpersonal skills\n- Ability to plan and work on projects with minimal supervision\n- Effective at working with colleagues from all departments and organizational levels while meeting commitments.\n- Experience working as a member of global drug development teams preferred\n- Previous management experience of direct reports or clinical projects\nProven experience in a pharmaceutical environment\n- Good experience of biopharmaceutical clinical research\n- Experience involving a broad exposure to biopharmaceutical clinical development process and procedures\n- Experience developing and implementing recruitment and retention plans\n- Experience working independently across departments within a team/matrix environment\n-Detailed knowledge of international clinical research and drug development\n- Strong understanding of program and study operations in an international setting\n-Relevant therapeutic area(s)\n- Strong computer literacy, including word processing, presentation, spreadsheet and project management applications\n- Organizational change management process", "date_new": "2012-05-21 18:10:58", "url": "http://www.amgen.jobs/xml/28832988/job", "country": "United States", "company": "Amgen", "title": "Feasibility & Patient Recruitment Mgr", "reqid": "15617BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28832988}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15771BR\nJob Posting Title Biostatistical Programming Mgr\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Biostatistical Programming Manager will be accountable for Global Statistical Programming (GSP) study activities and oversight of contingency workers within the product team. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA .\n\nThe Biostatistical Programming Manager is responsible for:\n\u2022 Writing, testing and validating software programs in UNIX to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications\n\u2022 Writing and/or reviewing statistical programming plans and dataset specifications.\n\u2022 Ensuring the analysis and presentation of biomedical data is accurate and complete.\n\u2022 Adherence to Amgen Policies, SOPs and other controlled documents\nBasic Qualifications \u2022 Bachelor\u2019s degree & 5 years of directly related experience\nPreferred Qualifications \u2022 MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022 Biostatistical Programming using the SAS System\n\u2022 Drug Development (pre-, early, late and/or observational) in related industries or academic research\n\u2022 Project planning\n\u2022 Process improvement participation\n\u2022 International co-operation\n\u2022 Team participation and effectiveness\n\u2022 Six (6) years relevant career experience", "date_new": "2012-05-20 19:44:41", "url": "http://www.amgen.jobs/xml/28824683/job", "country": "United States", "company": "Amgen", "title": "Biostatistical Programming Mgr", "reqid": "15771BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28824683}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15636BR\nJob Posting Title Sr Assoc Clinical Trial Mgmt Systems\nCareer Category Clinical\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Review and track global organizational performance metrics\nHighlight performance gaps and identify root cause; recommend meaningful improvement opportunities\nCo-ordinate the creation and distribution of metrics reports and other status reports as required\nManage benchmarking efforts\nInitiate and build relationships with study teams and business partners to understand study requirements\nDevelop protocol builds and budgets to meet study team requirements\nPartner with appropriate Dev IS resources on CAAS tools to meet client needs\nCollaborate with appropriate Dev IS resources of other systems to ensure consistency of data standards and quality\nCreate and distribute written materials to support training, data integrity, or other special projects (as assigned)\nProvide clients with outstanding support through effective communications and robust processes\nLead special projects as assigned\nGather stakeholder requirements on applications, metrics and reports\nDevelop processes and reporting to ensure compliance to data standards and compliance to business processes\nBasic Qualifications Master\u2019s degree\nOR\nBachelor\u2019s degree & 2 years of directly related experience\nOR\nAssociate\u2019s degree & 6 years of directly related experience\nOR\nHigh school diploma / GED & 8 years of directly related experience\nPreferred Qualifications BA/BS/BSc in the sciences or RN\nSpecialist work experience in business support role in the life sciences or medically related field\n5 years work experience in life sciences or medically related field, including 2 years of clinical development experience involving clinical applications (e.g. CTMS, IVRS, EDC", "date_new": "2012-05-18 18:07:27", "url": "http://www.amgen.jobs/xml/28792892/job", "country": "United States", "company": "Amgen", "title": "Sr Assoc Clinical Trial Mgmt Systems", "reqid": "15636BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28792892}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 15588BR\nJob Posting Title CDM Systems Mgr\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description The CDM Systems Manager will serve as global manager and as a technical team point-of-contact within Electronic Trial Operations (ETO). This role will work with cross-functional Amgen teams of Clinical, Biostatistical, Data Management, Supply Chain, as well as with external representatives. This role will drive the design, implementation and maintenance of outsourced electronic solutions in support of clinical trials. The role will provide the technical oversight required to ensure adherence to study specific requirements, Amgen policies, procedures, standards all within a regulated environment.\n\nThe position is expected to partner effectively with other CDM System staff to ensure high quality deliverables and to aggressively pursue opportunities to further propagate the use of ETO technology and services.\n\nKey Responsibilities include:\n\u2022 Lead study level system requirements meetings with internal and external clients\n\u2022 Design and oversee the development of study specific technical documents\n\u2022 Document possible risk and implement mitigation plans\n\u2022 Manage project related timelines and associated activities\n\u2022 Identify and track study-related technical issues to resolution\n\u2022 Provide a supportive framework for continuous process and quality improvements\n\nOther responsibilities include:\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Provide feedback on clinical protocols as it relates to electronic solutions and ensure the use of data standards and adoption of configurable modules\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such Vendor Providers) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications 5 years of experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry\n\n3 years of biopharmaceutical clinical research experience\n\nCandidate will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\n\u2022 6+ or more years of experience in a technical role within clinical data management, clinical development, clinical setting, or IS/IT\n\u2022 Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Experience successfully implementing and IVR and IWR systems\n\u2022 Work experience integrating other clinical technologies including but not limited to such technologies such as eClinical, RAVE, EDC or other related technology in the pharmaceutical/biotechnology industry\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Working knowledge of Good Clinical Practices and Global Regulatory regulations as applicable\n\u2022 Previous line management experience", "date_new": "2012-05-17 20:57:32", "url": "http://www.amgen.jobs/xml/28771038/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Mgr", "reqid": "15588BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 28771038}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15711BR\nJob Posting Title Medical Information Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This professional will be responsible for working within Medical Information in the Scientific Affairs organization and will be involved with communicating product information to internal and external customers. This position offers an opportunity to work in a matrix environment on a cross-functional team that is focused on supporting Amgen\u2019s innovative scientific programs.\n\nPrimary responsibilities include providing verbal and written clinical and technical information to internal and external customers as it relates to Amgen\u2019s inflammation products; facilitating intake and documentation of adverse events and product complaints as they relate to Amgen products; conducting literature reviews and analyses around the potential impact to the business; monitoring and reviewing the literature to identify competitive issues.\n\nAdditional responsibilities will include developing key deliverables in support of Amgen inflammation products; providing clinical support to other Amgen departments; developing and/or participating in training programs; supporting Amgen customers at major scientific meetings.\n\nKey deliverables and activities include the development of medical information letters; development of Clinical FAQs to be used by the MedInfo healthcare professional staff, regional medical liaisons and/or call center representatives; developing key literature surveillance outputs to ensure timely communication of key data across Amgen; and training vendor HCP staff on data and processes.\nBasic Qualifications ?Doctorate degree\nOR\n?Master\u2019s degree & 3 years of directly related experience\nOR\n?Bachelor\u2019s degree & 5 years of directly related experience\nOR\n\u2022Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Prior experience in Medical Information / Drug Information is strongly preferred. Two or more years of biotech/pharmaceutical and/or clinical experience are also preferred. Knowledge and understanding of clinical and therapeutic issues relevant to Rheumatology and Dermatology preferred.\nStrong verbal and written communication skills are required along with the ability to work in a matrix environment, across multiple teams. Proven scientific literature analysis and evaluation skills; organizational and project management skills, technical writing skills; computer literacy; and the ability to manage a large number of complex projects simultaneously.", "date_new": "2012-05-16 19:08:46", "url": "http://www.amgen.jobs/xml/28737812/job", "country": "United States", "company": "Amgen", "title": "Medical Information Mgr", "reqid": "15711BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737812}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15705BR\nJob Posting Title CDM Systems Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Serve as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams.\n\nThe Manager of Client System Services \u2013 CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner.\n\nThis position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen\u2019s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization.\nMentor and support junior staff\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT\n\u2022 Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery\n\u2022 Previous experience working in a global environment\n\u2022 Previous Data Manager in clinical development setting or study team related experience\n\u2022 Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable\n\u2022 Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable", "date_new": "2012-05-16 19:07:37", "url": "http://www.amgen.jobs/xml/28737777/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Mgr", "reqid": "15705BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28737777}, {"country_short": "CAN", "city": null, "description": "Auto req 15700BR\nJob Posting Title Sr Associate Contract Management (Contract)\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) Canada\nLocation (City) Mississauga\nAmgen Job Description Position: Senior Associate Clinical Contracts & Budgets\nReports to: Manager, Clinical Research Services\nGrade: 4\nStarting:August 2012 (13-month maternity-leave contract)\nLocation: Head Office, Mississauga\n\nInternal Candidates are required to have a discussion with their current manager regarding intent to apply.\n\nJob Purpose:\n\nTo manage all site-related contracting and budget negotiations and to process and track related payments in a timely and efficient manner.\n\nKey Job Functions:\n\n\n1. Negotiates contract with clinical trial site, responding to comments within defined parameters set (produced by Legal) and seeking legal input for issues outside parameters set\n\n2. Leads the review of the budget template with local project manager for country feedback on FMV (Fair Market Value) and the Schedule A template\n\n3. Negotiates site budget from the base budget and payment milestones using appropriate guidelines\n\n4. Escalates contract/budget issues to Legal, Pricing, and/or local & global study manager as appropriate\n\n5. Coordinates and participates in meetings with site/legal to resolve contract issues\n\n6. Manages, executes and reconciles payments ensuring that spending is within approved contract budgets\n\n7. Maintains contract and payment data tracking in appropriate databases and financial systems\n\n8. Manage internal stakeholder needs and expectations through regular communication regarding progress/status of pending contract and payment requests.\n\n9. Actively contributes to results-oriented global and local departmental goals\n\n10. Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness\nBasic Qualifications Qualifications/Experience\n\n\u2022 Bachelor\u2019s degree in a science or business field\n\u2022 3-5 years or more related experience in finance administration, project management, contracting or other relevant work experience in life sciences or medically related field\n\u2022 Work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO is preferred.\n\nCompetencies\n\n\u2022 Ability to work independently with little supervision as well as in a team environment\n\u2022 Strong Negotiation skills\n\u2022 Strong analytical and presentation skills\n\u2022 Excellent written and oral communication skills\n\u2022 Attention to detail\n\u2022 Persistent, tactful and persuasive\n\u2022 Proficiency with computer/database systems\n\u2022 Strong organizational skills with the ability to manage multiple priorities", "date_new": "2012-05-11 18:20:30", "url": "http://www.amgen.jobs/xml/28633380/job", "country": "Canada", "company": "Amgen", "title": "Sr Associate Contract Management (Contract)", "reqid": "15700BR", "state": null, "state_short": null, "location": "Virtual, CAN", "uid": 28633380}, {"country_short": "CHE", "city": "Zug", "description": "Auto req 15674BR\nJob Posting Title Senior Associate Clinical Operations Management\nCareer Category Clinical\nEmployee Subgroup Invoice Paid FT\nCountry (State/Region) Switzerland\nLocation (City) Zug\nAmgen Job Description The Sr. Associate, Clinical Operations Management will support Clinical Operations Managers with overseeing operational activities related to planning, executing, and reporting of Phase 3 and 4 Amgen sponsored clinical trials. Main responsibilies include:\n\nContribute to the design and preparation of the draft informed consent template, ensuring Local content is added\nAssist in the conduct of feasibility assessments for new clinical protocols if required\nContribute to the identification and selection of clinical investigators\nWork with the Clinical Operations Managers (COM\u2019s) and Senior Associate Clinical Operations Management (SACOMs) colleagues to formulate a comprehensive recruitment plan for each new project.\nContribute to the development of study specific processes including study communication plans\nParticipate in identifying study related issues, and work with the COM and MCFO to initiate corrective actions when necessary\nWith the study-specific COM, plan and conduct monthly project review meetings in order to update all Managers on study progress, issues and planned resolutions.\nParticipate in local team meetings, task forces and liaise with Global Study Team if required\nIdentifying and reviewing process issues within the clinical development group and recommending improvements when required\nAccompany CRA in site evaluations, initiations, monitoring and close out if required.\nAct as back up to COMs when required\nCoordinate & actively participate at local investigators meetings\nReview CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues\nPartners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs)\nFor studies with sole project management responsibility (eg Phase 4, follow up and extension studies)\nBasic Qualifications BA/BS/BSc or qualified nurse (RN)\nWork experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)\nPreferred Qualifications Project management experience in life sciences or medically related field obtained working on clinical trials in a biotech, pharmaceutical or CRO company\nOperational performance measurement experience\nInternational collaboration experience", "date_new": "2012-05-09 20:33:38", "url": "http://www.amgen.jobs/xml/28581226/job", "country": "Switzerland", "company": "Amgen", "title": "Senior Associate Clinical Operations Management", "reqid": "15674BR", "state": null, "state_short": null, "location": "Zug, CHE", "uid": 28581226}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15649BR\nJob Posting Title Clinical Research Medical Dir\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Medical Director (Biosimilars) is responsible for:\n\u2022 Supporting the development, execution and communication of the global clinical plan\n\u2022 Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n\u2022 Participating and providing clinical input into safety and regulatory interactions\n\u2022 Supporting the development of key scientific external relationships with opinion leaders\n\nKey Activities\n\u2022 Provide clinical/scientific input during the development and execution of clinical trials\n\u2022 Interpret clinical trial data\n\u2022 Participate in safety assessments\n\u2022 Participate in interactions with regulatory agencies\n\u2022 Author regulatory submissions and publications\n\u2022 Develop key opinion leaders and make scientific presentations\n\u2022 Support in-licensing and partner relationships\n\u2022 Support product lifecycle management\nBasic Qualifications \u2022 MD with clinical experience in Oncology\n\u2022 Three (3) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company\nPreferred Qualifications \u2022 MD plus accredited residency in Oncology, board certified or equivalent\n\u2022 Five (5) or more years of clinical research experience in biotech/pharma/CRO company and basic science research combined with clinical teaching or patient care activities\n\u2022 Experience in all phases of clinical research (Phase 1-4)\n\u2022 Experience interacting with FDA and international regulatory agencies\n\u2022 In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n\u2022 Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n\u2022 Sound scientific and clinical judgment\n\u2022 Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n\u2022 Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n\u2022 Demonstrated ability as a medical expert in a complex matrix environment\n\u2022 History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-05-07 18:07:01", "url": "http://www.amgen.jobs/xml/28478115/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Dir", "reqid": "15649BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28478115}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15618BR\nJob Posting Title Epidemiology Sr Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Observational research (OR) makes important contributions to drug development and commercialization along with randomized clinical trials. OR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions. In the current environment, there is increasing demand for information from OR studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) has been created to address this imperative.\n\nJob Summary\n\nThe OR Sr. Manager is a major contributor within one of the CfOR Therapeutic Areas (Oncology, Bone, Cardio/Renal, General Medicine & Inflammation) and reports directly to a Product Lead.\n\nThis position will be located at Amgen's Thousand Oaks headquarters.\n\nAn OR Sr. Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer reviewed journals or for internal reports that enhance the company\u2019s mission.\n\nKey Activities Include\n\u2022 Contributes to research strategy within the product team and observational research TA\n\u2022 Responsible for conducting high-quality observational research to support product strategy within TA\n\u2022 Executes safety-related analyses/studies\n\u2022 Provides support for safety surveillance across the life cycle of Amgen products\n\u2022 Support preparation of PSRM materials\n\u2022 Executes process of patient exposure estimation for marketed products\n\u2022 Supports development of risk management plans\n\u2022 Plans and conducts database analyses to answer key questions with the product teams\n\u2022 Collaborates with Health Economics colleagues to generate evidence to support the value plan\n\u2022 Participates in cross-functional teams to develop the research strategy for products and conducts the observational research\n\n\u2022 Supports relationships with key leaders in observational research\n\u2022 Sets annual product-specific and personal goals\n\u2022 Provides input into observational research department meetings\n\u2022 Stays abreast of the latest developments in the field of observational research and drug development and contributes to the field\n\u2022 Promotes observational research awareness\n\u2022 Promotes understanding and use of state of the art observational research methods\n\u2022 Communicates significant scientific information to a variety of audiences\nBasic Qualifications Doctorate degree & 2 years of directly related experience\nOR\nMaster\u2019s degree & 6 years of directly related experience\nOR\nBachelor\u2019s degree & 8 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Preferred Qualifications \u2022 PhD degree in Epidemiology or Medical degree with observational research experience\n\u2022 6 or more years experience in observational research\n\u2022 Record of publications in peer-reviewed journals\n\u2022 3 years experience with Medical or Doctoral degree\n\u2022 Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting\n\u2022 Experience in research to support drug development\n\u2022 Experience in observational research project planning and management\n\u2022 Experience communicating observational research information (written and oral)\n\u2022 Experience working in multi-disciplinary teams\n\u2022 Managerial experience\n\nKnowledgeable in\n\u2022 Basic observational research study designs and analysis\n\u2022 Programming in SAS or other software (e.g. STATA)\n\u2022 Literature search methods\n\u2022 Observational research methodology and applications within Drug Development\n\u2022 Drug development process and operations\n\u2022 Observational research databases\n\u2022 Knowledge of adverse drug experience data", "date_new": "2012-05-07 18:05:15", "url": "http://www.amgen.jobs/xml/28478106/job", "country": "United States", "company": "Amgen", "title": "Epidemiology Sr Mgr", "reqid": "15618BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28478106}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 15562BR\nJob Posting Title Sr Associate Biostatistical Programming\nCareer Category Clinical\nEmployee Subgroup Hourly FT\nCountry (State/Region) United States - California\nUnited States - Washington\nLocation (City) Seattle\nSouth San Francisco\nThousand Oaks\nAmgen Job Description Position can be filled in Thousand Oaks, CA, San Francisco, CA or Seattle, WA\n\n\u2022Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan, NONMEM specifications\n\u2022Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications\n\u2022Understand and execute department-, product- and study-level macros and utilities\n\u2022Write, test and validate product- and study-level macros and utilities\n\u2022Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings\n\u2022Provide input to and participate in intra-departmental and GBDS meetings\n\u2022Contribute to the continuous improvement of Global Biomedical Data Sciences (GBDS) and programming\n\u2022Assist in the review of GBDS policies, standard operating procedures and other controlled documents\n\u2022Provide support to and mentor more junior programmers\n\u2022Interface with outsourcing partners and vendors\n\u2022Attend external professional organizations, conferences, training and/or meetings\n\nKnowledge\n\u2022Computer programming, preferably SAS or other procedural languages\n\u2022Fundamentals of Project Planning and Management\n\u2022Drug Development Process & Operations\nBasic Qualifications \u2022BS/BSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022Three (3) years relevant career experience\nPreferred Qualifications \u2022MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject\n\u2022Drug Development (pre-, early, late and/or observational) in related industries or academic research\n\u2022Four (4) years relevant career experience", "date_new": "2012-05-03 18:01:32", "url": "http://www.amgen.jobs/xml/28403680/job", "country": "United States", "company": "Amgen", "title": "Sr Associate Biostatistical Programming", "reqid": "15562BR", "state": "California", "state_short": "CA", "location": "Seattle, CA", "uid": 28403680}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15401BR\nJob Posting Title Clinical Data Mgmt Mgr\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Data Management Manager will be accountable for CDM study activities and oversight of the CROs and the Functional Service Provider for multiple therapeutic areas including Early Development Oncology. This role is part of a Therapeutic study team located at Amgen's headquarters in Thousand Oaks, CA . The preference is for the person to be located in Thousand Oaks, CA.\n\n\nThe Clinical Data Mgr\u2019s responsibilities include:\n\nCo-ordination and mentoring of lead data managers within assigned projects\n\nLeading CDM activities for assigned study teams\n\nEnsuring clinical projects are executed according to set timelines with quality and consistency\n\nEnsuring that CDM procedures and processes are adhered to\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications Bachelors degree in life science, computer science, business administration or related discipline\n\n6+ years work experience in clinical data management in the Pharmaceutical or Biotech arena\n\n3+ years project management and planning experience\n\nExperience in oversight of outside vendors (CRO\u2019s, central labs, imaging vendors, etc.)\n\nExperience working in Medidata Rave 5.x\n\nSolid understanding of clinical data handling procedures related to clinical oncology in solid tumor indications", "date_new": "2012-04-26 18:19:48", "url": "http://www.amgen.jobs/xml/28203622/job", "country": "United States", "company": "Amgen", "title": "Clinical Data Mgmt Mgr", "reqid": "15401BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28203622}, {"country_short": "GBR", "city": "Uxbridge", "description": "Auto req 15165BR\nJob Posting Title International Dev Medical Dir\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United Kingdom\nLocation (City) Uxbridge\nAmgen Job Description Overview:\n\nThis is a newly formed role in the International Bone, Neuroscience & Inflammation TA.\nAMG 785 is a key program for Amgen and reached EoP2 in summer 2011 for the PMO program and is advancing into phase 3 with two phase 3 PMO protocols, currently planned to start enrollment in 2012. Ongoing phase 2 activities for this molecule includes fracture healing programs in hip and tibia fracture. Proof of concept does not yet exist in these indications. It is expected that the IML for AMG 785 partners with the Prolia IML as appropriate, since strategic alignment is required between these two molecules (partnered with UCB and GSK respectively).\n\nKey responsibilities:\n\n\u2022 Implementation and completion of AST\u2019s (Amgen sponsored studies)\n\u2022 Leads development of study protocols for International AST\u2019s; supports and executes international study protocol preparation, filing, review and approval in line with Amgen processes and policies\n\u2022 Ensures that International input is included as appropriate in GSP/GDP and global study protocols and SCD\u2019s\n\u2022 Supports Affiliates in protocol development of Local AST\u2019s and approves Local AST\u2019s prior to IPRC submission (in conjunction with GDO)\n\u2022 Identify/resolve issues related to study design that arise during study execution\n\u2022 Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program\n\u2022 Participates in the development of Global strategies and tactics in close collaboration with the GDL and the International TA Head\n\u2022 Visits selected KOLs and study groups for strategic discussions and protocol development\n\u2022 Reviews International and Local ISS proposals\n\u2022 Partners with the International Brand Directors in the development and execution of the International product(s) lifecycle management plan\n\u2022 Oversees in-sourced/outsourced International medical programs and logistics\n\u2022 Supports regulatory and ethics approvals for Global development studies\n\u2022 Organizes and/or conducts International Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate\n\u2022 Member of respective IBT\n\u2022 Provides medical expertise for pipeline products\n\u2022 Provides medical expertise for Health Economy and reimbursement requests\n\u2022 Chairs the International Medical Team (IMT)\nBasic Qualifications \u2022 Medical degree with deep scientific expertise in\nPreferred Qualifications \u2022 Substantial clinical development experience, preferably from a pharmaceutical or possibly well established biotechnology company\n\u2022 Experience with clinical study management and conduct\n\u2022 Broad and formal leadership experience\n\u2022 Commercial acumen, ideally launch experience\n\u2022 Knowledge of pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs\n\u2022 Therapeutic area knowledge\n\u2022 Network of customer contacts in therapeutic area\n\u2022 Finance and budgeting experience", "date_new": "2012-04-24 20:49:23", "url": "http://www.amgen.jobs/xml/28152716/job", "country": "United Kingdom", "company": "Amgen", "title": "International Dev Medical Dir", "reqid": "15165BR", "state": null, "state_short": null, "location": "Uxbridge, GBR", "uid": 28152716}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14290BR\nJob Posting Title CDM Systems Manager\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description THIS ROLE CAN BE BASED AT AMGEN\u2019S THOUSAND OAKS, CA OR SOUTH SAN FRANCISCO SITE\n\nServe as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams.\n\nThe Manager of Client System Services \u2013 CDM Systems Interface (CSI) role will ensure the proper, timely, and successful setup and implementation of clinical data management services during study startup, study maintenance, and study closeout for individual study teams. The CSI will ensure the most effective use, implementation, and observance of systems and data standardization, and status of CDM System services including but not limited to EDC, clinical trial database programming deliverables, including database, edit check, custom report programming, CDM Systems lab administration, CDM SAS programming deliverables, including data transfer plans, electronic data load, lab range entry, lab data review, IVRS, IWT, and SAS macros and other clinical data management activities according to study startup timelines in a regulatory compliant manner.\n\nThis position is expected to partner effectively with other CDM System team members to seamlessly ensure high quality deliverables serving as the primary point of contact as a program management function to the systems and technology setup and operations supporting study management activities. The CSI is expected to ensure and support continuous global operations of Amgen\u2019s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization.\n\nOther responsibilities include:\n\u2022 Mentor and support junior staff\n\u2022 Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines.\n\u2022 Procurement and program management of resources, timeline, and services from both internal and external service providers\n\u2022 Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology\n\u2022 Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers\n\u2022 Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives\n\u2022 Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished\n\u2022 Develop strong relationship with external providers (such as FSP and Vendor Provider) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT\n\u2022 Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery\n\u2022 Previous experience working in a global environment\n\u2022 Previous Data Manager in clinical development setting or study team related experience\n\u2022 Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable\n\u2022 Work experience implementing other clinical technologies including but not limited to IVRS, IWT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable", "date_new": "2012-03-14 03:14:47", "url": "http://www.amgen.jobs/xml/27126977/job", "country": "United States", "company": "Amgen", "title": "CDM Systems Manager", "reqid": "14290BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 27126977}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14150BR\nJob Posting Title Principal Scientist (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department.\n\nThe Principal Scientist will be the PKDM Development Project Team Representative on the Early and/or Global Development Teams in the area of Oncology. He/she will support small and large molecule drug development, registration, and post-marketing activities. He/she will be responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution, and functional representation for Amgen internal governance reviews, face-to-face interactions with global regulatory authorities, and external scientific communities. The individual will effectively lead PKDM Development Project Team, and interface with internal business stakeholders (such as Clinical Development, Early Development, Biostatistics, Regulatory Affairs, Research, Toxicology, etc.). This PKDM Development Project Team Reprehensive will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications - Doctorate degree & 5 years of scientific experience\nOR\n- Master\u2019s degree & 12 years of scientific experience\nOR\n- Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required\n- Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) in Oncology with working knowledge in bioanalytical and drug metabolism\n- Experience in PK/PD modeling and population-based analyses/simulations (e.g. hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc) and PK analysis (e.g. proficiency in WinNONLIN)\n- Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Excellent interpersonal, technical, and communication skills that enable effective management and resolution of complex issues involving collaborations within a cross-functional team setting\n- Project management skills for timeline tracking and resource planning\n- Comprehensions in R&D processes for small molecules and/or protein therapeutics. General understanding in biology (mechanism of action)/pharmacology, toxicology, clinical immunology, protein sciences, statistics, pharmaceutics, and clinical development, etc.", "date_new": "2012-02-29 22:31:16", "url": "http://www.amgen.jobs/xml/26849248/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist (Quantitative Pharmacology/PKDM)", "reqid": "14150BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849248}, {"country_short": "USA", "city": "Seattle", "description": "Auto req 14154BR\nJob Posting Title Director Preclinical (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - Washington\nLocation (City) Seattle\nAmgen Job Description Amgen, Inc. is seeking a highly motivated candidate for the position of Director in the Quantitative Pharmacology Group of the PKDM Department.\n\nThe Director will provide strategic vision and portfolio leadership in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for portfolio-level strategic and resource planning, communication, scientific/technical deliverables, and issue resolution. A key focus will be to serve as functional representation for Amgen internal governance reviews and external scientific and regulatory communities including face-to-face interactions with global regulatory/health authorities.\n\nThe individual will interface with internal business stakeholders (such as Research, Toxicology, Early Development, Clinical Development, Biostatistics, CMC, Regulatory Affairs, etc.). The candidate will mentor and advise a group of project team representatives at all stages of discovery and clinical development and implement advanced modeling & simulation (M&S) strategies across the portfolio to influence decision making. The individual will be responsible for the development of key operational efficiencies and new technologies within the quantitative pharmacology group.\nBasic Qualifications - Doctorate degree & 7 years of scientific experience\nPreferred Qualifications - PhD in Pharmacokinetics, Pharmaceutical Sciences, or with equivalent professional degrees (e.g. MD, PharmD) with 10 years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training\n- Experience as PKDM/Clinical Pharmacology functional representative on product development teams\n- Experience with PK and PK/PD data analysis, interpretation, and reporting for small molecule and/or protein therapeutics\n- Hands-on experiences in population PK/PD modeling and simulations (M&S)\n- Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities\n- R&D experience in oncology therapeutics, inflammation and/or metabolic therapeutic areas\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Excellent interpersonal, technical, and communication skills to lead a group of quantitative pharmacology scientists\n- Excellent problem scoping, planning and business skills necessary to drive decision making and influence senior leadership\n- Project management skills for timeline tracking and resource planning\n- Solid publication record as senior author and growing reputation with external peers.\n- The successful candidate will have strong interpersonal communication and leadership skills.", "date_new": "2012-02-29 22:30:57", "url": "http://www.amgen.jobs/xml/26849234/job", "country": "United States", "company": "Amgen", "title": "Director Preclinical (Quantitative Pharmacology/PKDM)", "reqid": "14154BR", "state": "Washington", "state_short": "WA", "location": "Seattle, WA", "uid": 26849234}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14148BR\nJob Posting Title Sr Scientist (Quantitative Pharmacology/PKDM)\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Senior Scientist in the in the Quantitative Pharmacology Group of Pharmacokinetics and Drug Metabolism (PKDM) Department.\n\nThe Senior Scientist will serve as a PK/PD expert to support early and late development programs in various therapeutic areas (e.g. Neurosciences, Cardiovascular, or other therapeutic areas). The individual will effectively interface within the PKDM department and with external functions (such as Early Development, Clinical Development, Biostatistics, Statistical Programming, Clinical Data Management, Regulatory Affairs, etc.). The successful candidate will develop PK/PD strategy, perform modeling & simulation analyses and report writing, and prepare regulatory document sections as appropriate. This individual may also serve as a PKDM Development Project Team Reprehensive who will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent Amgen PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications - Doctorate degree & 2 years of scientific experience\nOR\n- Master\u2019s degree & 8 years of scientific  experience\nOR\n- Bachelor\u2019s degree & 10 years of scientific experience\nPreferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 3+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required\n- Specialized in PK/PD modeling and population-based analyses/simulations (hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc).\n- Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s)\n- Excellent interpersonal, scientific, technical, and communication skills that enable effective management and resolution of complex, project-related issues involving multiple functional areas and levels of management.\n- Knowledge of PK and PK/PD for small molecule and/or protein therapeutics.\n- Leadership quality for effective team building with strong decision making and problem solving skills\n- Experience in authoring regulatory documentation (IND, IMPD, CTX, etc) and interaction with regulatory authorities.\n- Experience as PK/PD lead on discovery or development project teams in Neurosciences, Cardiovascular, or other therapeutic areas.", "date_new": "2012-02-29 22:30:55", "url": "http://www.amgen.jobs/xml/26849231/job", "country": "United States", "company": "Amgen", "title": "Sr Scientist (Quantitative Pharmacology/PKDM)", "reqid": "14148BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849231}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 14147BR\nJob Posting Title Clinical Research Sr Medical Scientist - Cardiology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Clinical Research Sr. Medical Scientist is responsible for:\n\n- Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Participating and providing clinical input into safety and regulatory interactions\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)\n- Interpret clinical trial data\n- Participate in safety assessments\n- Review and provide clinical scientific input to TLGs and safety narratives\n- Review scientific literature\n- Initiate database analyses to support commercial/clinical objectives\n- Contribute to the preparation of clinical study reports and regulatory submissions\n- Participate in interactions with regulatory agencies\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL\n- Identify new clinical research opportunities\n\nKnowledge:\n\n- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Medical knowledge in the relevant therapeutic area\n- Sound scientific and clinical judgment\n- Familiarity with regulatory agency organization, guidelines, and practices\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues\nBasic Qualifications M.D. degree\nPreferred Qualifications - M.D. plus accredited residency in Cardiology, board certified or equivalent\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities", "date_new": "2012-02-29 22:29:59", "url": "http://www.amgen.jobs/xml/26849201/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Sr Medical Scientist - Cardiology", "reqid": "14147BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26849201}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13564BR\nJob Posting Title Clinical Research Medical Director - Hematology / Oncology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Medical Director will work within the Hematology/Oncology Therapeutic Area.\n\nThe responsibilities for this role include:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- Experience in clinical research in hematology and/or oncology", "date_new": "2012-02-16 21:58:36", "url": "http://www.amgen.jobs/xml/26576276/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Hematology / Oncology", "reqid": "13564BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26576276}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13963BR\nJob Posting Title Principal Scientist\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This is an exciting opportunity in the Early Development/ Molecular Sciences group at Amgen that could be situated in either the Seattle, WA or Thousand Oaks, CA campus for an individual to explore and apply pharmacodynamic and patient stratification biomarkers in the context of informing the decision-making process in drug development for cardiovascular therapeutics. The successful candidate will be responsible for leading and coordinating the biomarker effort for a portfolio of concurrent research and clinical projects. This responsibility would extend from efforts discovering and evaluating candidate biomarkers to overseeing the execution of biomarker assessments in clinical trials. The candidate will drive the implementation of biomarker strategy in clinical studies through close collaboration with discovery research, preclinical and early clinical development teams in the metabolism and general medicine areas. The candidate will also be responsible for organizing and contributing to the cross-functional and cross-site team interaction including meetings, reports and presentations.\nBasic Qualifications \u2022 Doctorate degree & 5 years of scientific experience\nOR\n\u2022 Master\u2019s degree & 12 years of scientific experience\nOR\n\u2022 Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022Ph.D in life sciences and 2+ years of post-doctoral experience and 4+ years of industry experience.\n\u2022Experience in the discovery and implementation of biomarkers within clinical studies for cardiovascular disease (e.g. lipid regulation, dyslipidemia, atherosclerosis).\n\u2022Strong desire to be part of the flexible and dynamic environment of early development, and be capable of supporting a broad portfolio of novel projects.\n\u2022A strong background in cardiovascular biology, with emphasis on the understanding of pathway interventions applied as therapeutics.\n\u2022Strong skills in critical thinking, laboratory experimentation and analysis, and understanding of the advantages and limitations of exploratory analyses in the clinical setting.\n\u2022Effective communication and interpersonal skills and the ability to work in a matrix environment are essential.", "date_new": "2012-02-15 22:00:25", "url": "http://www.amgen.jobs/xml/26547305/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist", "reqid": "13963BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26547305}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13910BR\nJob Posting Title Medical Sciences Medical Dir - Oncology\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Medical Sciences Group is looking for a strong leader in Hematology/Oncology.\n\nThe Medical Sciences leaders identify, organize, and execute early phase clinical and translational projects and substantially contribute to drug development. Throughout this continuum, they identify and manage external collaborators and consultants in completion of key projects. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They typically serve as project leaders for at least one of Amgen\u2019s Product Strategy Teams through their role as an Early Development Leader (EDL).\n\nThis person filling this position must have demonstrated expertise in conducting translational and/or clinical oncology research, and will be the primary Medical Sciences contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing later clinical development.\n\nIn addition, the candidate will have the following responsibilities:\n\nServe as an internal clinical expert in translational and clinical oncology.\n\nServe as medical monitor for clinical trials and assists in resolving major issues that may affect the studies.\n\nPresent information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.\n\nCoordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.\n\nProvide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.\n\nEnsure appropriate training, recruitment, and development requirements for matrix team resources.\nBasic Qualifications \u2022MD\n\u2022Two(2)or more years of clinical research and/or basic science research experience\nPreferred Qualifications \u2022MD plus accredited residency in Oncology and/or Malignant Hematology, board certified\n\u2022MD/PhD and a strong basic science or clinical research background in academics or pharma\n\u2022Effective presentation and communication abilities (both written and oral)\n\u2022Ability to anticipate problems and find creative solutions\n\u2022In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n\u2022A record of high quality peer-reviewed publications\n\u2022Experience functioning as a medical expert in a complex matrixed environment\n\u2022Previous experience in early phase development and/or biomarker work is a strong plus", "date_new": "2012-02-15 21:59:43", "url": "http://www.amgen.jobs/xml/26547283/job", "country": "United States", "company": "Amgen", "title": "Medical Sciences Medical Dir - Oncology", "reqid": "13910BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26547283}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13888BR\nJob Posting Title Medical Sciences Medical Dir\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The candidate must be able to identify and organize preclinical and clinical scientific data in order to execute on early clinical studies that substantially contribute to early product development. Serve as a leader within Early Development (ED), with an interest and growing capability in representing the department on internal groups, such the ED protocol review committee. Identify and maintain relationships with key external collaborators. Contribute critical intellectual insights to strategy for generating decision-making, early clinical trial data. Collaborate in a team atmosphere, on interpretation and reporting of early clinical trial data. Responsible for responding to queries from regulatory agencies and participate in negotiations with these groups. The successful candidate will have the opportunity to lead late stage pre-clinical/early clinical Product Strategy Teams (PST) for Amgen\u2019s early development pipeline.\nBasic Qualifications \u2022 MD\n\u2022 3 years clinical trial experience in industry and/or academic setting\nPreferred Qualifications \u2022 Residency in Internal Medicine or related discipline\n\u2022 Subspecialty fellowship training in Clinical Pharmacology, or an Internal Medicine subspecialty, with a background in translational medicine\n\u2022 Experience interacting with or serving on an IRBs or Ethics Committees\n\u2022 Board certification or eligible\n\u2022 M.D./Ph.D. in biological science\n\u2022 Excellent oral and written communication skills\n\u2022 Excellent interpersonal skills\n\u2022 Experience in early clinical trials\n\u2022 Solid understanding of GCP and Healthcare Compliance\n\u2022 Experience in basic research and clinical trial methodology\n\u2022 Publication track record\n\u2022 Ability to lead, manage and motivate teams", "date_new": "2012-02-14 20:00:48", "url": "http://www.amgen.jobs/xml/26520634/job", "country": "United States", "company": "Amgen", "title": "Medical Sciences Medical Dir", "reqid": "13888BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26520634}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13890BR\nJob Posting Title Principal Scientist - PKDM\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Amgen is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will serve as a PK/PD expert and Pharmacometrican to support Amgen Development and Discovery programs in the Oncology Therapeutic Area. The successful candidate will implement advanced modeling & simulation (M&S) strategy, develop M&S cutting edge methodology, and work collaboratively with cross-functional teams to optimize PK/PD study design and study protocol. He/she will be responsible for hands-on PK/PD analyses, modeling & simulations, report writing, and the preparation and maintenance of Investigator Brochures, IND/IMPD/CTX/RTQ/CTD, and other summary documents for regulatory submissions. He/she may transition into the role of PKDM Development Project Team Representative and independently represent the function area when appropriate. Development of junior members and interaction with the line-management will also be key responsibilities.\nBasic Qualifications \u2022Doctorate degree & 5 years of scientific experience\nOR\n\u2022Master\u2019s degree & 12 years of scientific experience\nOR\n\u2022Bachelor\u2019s degree & 15 years of scientific experience\nPreferred Qualifications \u2022PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training\n\u2022Specialized in PK/PD modeling and population-based analyses/simulations with established track-record records of model-based drug development\n\u2022Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations.\n\u2022Leadership quality for effective team building with strong decision making and problem solving skills\n\u2022Excellent interpersonal, technical, and communication skills to lead cross-functional teams\n\u2022Candidate with R&D experience to support small and/or large molecule oncology therapeutics\n\u2022Demonstrated experience with modeling and simulation software (e.g. NONMEM, SAS, S-Plus, Pharsight Clinical Trial Simulator)\n\u2022Excellence and eminence in field of PK/PD and modeling & simulation with peer-review articles and external presentations.", "date_new": "2012-02-10 18:17:40", "url": "http://www.amgen.jobs/xml/26456588/job", "country": "United States", "company": "Amgen", "title": "Principal Scientist - PKDM", "reqid": "13890BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26456588}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 13870BR\nJob Posting Title Clinical Research Medical Director - Oncology - Xgeva\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description This Clinical Research Medical Director is responsible for:\n\n- Supporting the development, execution and communication of the global scientific/medical evidence plan\n- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program\n- Supporting the development of key scientific external relationships with opinion leaders\n- Participating and providing clinical input into safety and regulatory interactions\n\nKey Activities:\n\n- Provide clinical/scientific input during the development and execution of clinical trials\n- Interpret clinical trial data\n- Participate in safety assessments\n- Participate in interactions with regulatory agencies\n- Author CSRs, publications and regulatory submissions\n- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL\n- Identify new clinical research opportunities\n- Support in-licensing and out-licensing activities and partner relationships\n- Support product lifecycle management for new indications as directed by Global Development Leader\n- Provide clinical content input to:\n- Regulatory interactions and documents\n- Safety interactions and documents\n- Materials to be used in Scientific Affairs\n- Materials to be used by the Commercial Organization\nBasic Qualifications - MD\n- Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\nPreferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent\n- Experience in GU Oncology\n- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities\n- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)\n- prior oncology clinical research / experience\n\nKnowledge\n\n- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale\n- Familiarity with concepts of clinical research and clinical trial design, including biostatistics\n- Sound scientific and clinical judgment\n- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements\n- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication\n- Demonstrated ability as a medical expert in a complex matrix environment\n- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues", "date_new": "2012-02-09 23:44:48", "url": "http://www.amgen.jobs/xml/26445010/job", "country": "United States", "company": "Amgen", "title": "Clinical Research Medical Director - Oncology - Xgeva", "reqid": "13870BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 26445010}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 12729BR\nJob Posting Title Biomedical Data Stewardship Sr Manager\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description \u2022 Drive and facilitate the expansion of data presentation standards within GBDS taking primary responsibility for standardizing the presentation of clinical trial results in Tables, Figures and Listings. The role is positioned within the Biomedical Data Stewardship (BMDS) organization and the successful candidate would work alongside other BMDS staff in the development of end-to-end data standards and ensure that TFL requirements are considered in the development of collection standards.\n\n\u2022 Lead the Global Standardized Data Presentation Governance Committee\n\n\u2022 Lead the continuous improvement of data presentation processes and supporting technology\n\nResponsibilities:\n\n\u2022 Ensuring best data presentation practice through leadership of cross-functional Global Standardized Data Presentation Governance Committee\n\n\u2022 Maintaining compliance and compatibility with CDISC standards particularly ADaM.\n\n\u2022 Contributing to the development and strategy of the GBDS Data Stewardship organization\n\nKey Activities:\n\n\u2022 Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training\n\n\u2022 Track key metrics and reporting to GBDS and R&D Senior Management\n\n\u2022 Lead, motivate and develop the Global TFL Committee\n\n\u2022 Develop and maintain strong working relationships with key stakeholders\nBasic Qualifications - Doctorate degree & 2 years of directly related experience\nOR\n- Master\u2019s degree & 6 years of directly related experience\nOR\n- Bachelor\u2019s degree & 8 years of directly related experience\nOR\n- Associate\u2019s degree & 10 years of directly related experience\nOR\n- High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications - Bachelors degree in statistics/ biostatistics, programming, life science, computer science\n\n- 8 years work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena\n\n- 3+ years experience in a global organization\n\n- Demonstrated ability to influence decision making\n\n- Development of policies and SOPs\n\n- Experience collaborating on global cross-functional teams\n\n- Knowledge of project management, documentation writing, training, and compliance\n\n- Interest in process improvement methodologies\n\n- Use of software and data applications within drug development\n\n- Appreciation of computer system architecture and hardware", "date_new": "2011-11-28 21:33:28", "url": "http://www.amgen.jobs/xml/25067075/job", "country": "United States", "company": "Amgen", "title": "Biomedical Data Stewardship Sr Manager", "reqid": "12729BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 25067075}, {"country_short": "USA", "city": "South San Francisco", "description": "Auto req 12764BR\nJob Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site.\n\nThe CDM Systems Mgr \u2013 EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen\u2019s global Electronic Data Capture Operations service. The manager will have operational responsibility for delivery of electronic data collection systems such as Medidata Rave and Oracle InForm. These responsibilities include the delivery of EDC system capabilities, design and implementation of key system integrations, and the development of system-related EDC best practices.\n\nThe position is expected to partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report programming, and other clinical data management activities related to the use electronic data capture technology. Through active service management of service providers the manager is responsible for representing Amgen in supporting the Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services, ensuring quality service delivery and supplier performance.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT\n\u2022 Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm\n\u2022 Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable\n\u2022 Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable\n\u2022 Leadership Skills : The manager, EDC Operations will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have extensive clinical trial technical experience and leadership expertise. He or she will have substantial technical background to deliver the EDC operations associated with the Amgen portfolio. With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues.\n\nThe ideal candidate has a proven track record and experience in either working in and/or leading a technical team. The candidate must be able to represent Amgen\u2019s business requirements and needs by effective partnering and working with outsourced service delivery partners such as an FSP, ensure operational experience with clinical database management systems (preferably Medidata Rave and Oracle InForm) and have strong communication skills to maintain a high level of transparency between CDM systems centers of excellence, clinical study team members, CDM business units, and other stakeholders.", "date_new": "2011-11-28 21:31:18", "url": "http://www.amgen.jobs/xml/25067023/job", "country": "United States", "company": "Amgen", "title": "Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations", "reqid": "12764BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 25067023}]