Amgen Jobshttp://www.amgen.jobs2012-05-26 15:09:53.941993USAThousand OaksAuto req 15616BR Job Posting Title Feasibility & Patient Recruitment Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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’s 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. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications Advanced Degree preferred - Excellent communication, organizational, and interpersonal skills - Ability to plan and work on projects with minimal supervision - Effective at working with colleagues from all departments and organizational levels while meeting commitments. - Experience working as a member of global drug development teams preferred - Previous management experience of direct reports or clinical projects Proven experience in a pharmaceutical environment - Good experience of biopharmaceutical clinical research - Experience involving a broad exposure to biopharmaceutical clinical development process and procedures - Experience developing and implementing recruitment and retention plans - Experience working independently across departments within a team/matrix environment -Detailed knowledge of international clinical research and drug development - Strong understanding of program and study operations in an international setting -Relevant therapeutic area(s) - Strong computer literacy, including word processing, presentation, spreadsheet and project management applications - Organizational change management process2012-05-21 18:12:39United StatesAmgenCalifornia15616BRCAThousand Oaks, CA28833051http://www.amgen.jobs/xml/28833051/jobUSAThousand OaksAuto req 15775BR Job Posting Title Executive Medical Director Global Development - Neurology Career Category Clinical Development Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. Key Activities include the following: Scientific - Oversee activities related to planning for studies across the product lifecycle - Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the overall program strategy - Provide input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups - Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, clinical study reports, publications and reimbursement submissions) - Provide strategic medical input into all aspects of the Commercialization process (pre-clinical through launch) - Approve medical/scientific components of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs - Communicate current safety and efficacy/effectiveness status of the product internally and externally - Review, approve, and execute publication plan - Provide medical support for licensing activities and support partner relationships Leadership, Collaboration and Management - Co-lead multidisciplinary product strategy team with the Global Commercial Leader - Co-author Global Strategic Plan - Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions - Mentor, coach, and oversee the performance of direct reports - Provide oversight and ensure alignment between clinical development and development operations. - Provide medical/scientific support to other functions as appropriate - Support regional needs for medical/scientific evidence generation - Develop key relationships with global opinion leaders Knowledge - Proven success in development and execution of clinical trials - Excellent knowledge of disease states in therapeutic area - Familiar with investigators or institutions in therapeutic area - Knowledge of regulatory affairs and drug safety - Proven track record in publications - Proven track record in commercialization and business practices - Documented success leading, managing and motivating staff in a complex, multi-functional matrix environment Basic Qualifications MD • Five (5) or more years of either industry or academic research experience • Previous management experience Preferred Qualifications Preferred Qualifications • MD plus accredited residency in relevant sub-specialty (ie, Neurology), board certified • Eight (8) or more years of either industry or academic research experience • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) • Clinical research experience with Migraine programs2012-05-21 18:11:47United StatesAmgenCalifornia15775BRCAThousand Oaks, CA28833024http://www.amgen.jobs/xml/28833024/jobNLDBredaAuto req 15718BR Job Posting Title Clinical Operations Manager Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Field Based Amgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification and site selection Strategically plans and coordinates Amgen sponsored trials (forecasting, resourcing, timelines, baseline recruitment) Adapt ICF to local requirements Defines study specific processes including study communication plans Ensures all study staff understand study deliverables and timelines Tracks local trial implementation, data collection and study reporting Reviews and approves monitoring reports and Site Initiation Packages (SIPs) Responsible with Medical staff for vendor selection and performance evaluation for local studies, including HE studies (services other than FSP) Provides regular updates on study progress to DOM and study sponsors as required, identifying barriers to site activation and patient enrollment and identifying potential solutions Ensures quality of study execution Escalates study-related issues Provides Amgen presence at investigator meetings / key visits Coordinate & actively participate at local investigators meetings Review GCA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Key interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up Project manages local clinical study teams Coordinates SACOM tasks, according to the COM-SACOM RASCI, when those are allocated to support COMs in the oversight of operational activities related to planning, executing and reporting of phase 3 / 4 studies Single point of contact at a project level for LOC staff and GSM Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) Identifies and highlights risk areas (concerning operational readiness, communication and management) Ensures CRA receives necessary TA-related and study-related training Coordinates local study-related administrative tasks e.g. information to finance, status update to BU, status updates in local meetings Actively participates in the regional COM network as required Participate in the hub or country level Functional Management Team (FMT Governance) Basic Qualifications BA/BS/BSC or qualified nurse (RN) work 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) Preferred 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 Clinical trial management experience Operational performance measurement experience International collaboration experience2012-05-21 18:11:05NetherlandsAmgenNone15718BRNoneBreda, NLD28832994http://www.amgen.jobs/xml/28832994/jobUSAThousand OaksAuto req 15617BR Job Posting Title Feasibility & Patient Recruitment Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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’s 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. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred Qualifications Preferred Qualifications - Advanced Degree preferred - Excellent communication, organizational, and interpersonal skills - Ability to plan and work on projects with minimal supervision - Effective at working with colleagues from all departments and organizational levels while meeting commitments. - Experience working as a member of global drug development teams preferred - Previous management experience of direct reports or clinical projects Proven experience in a pharmaceutical environment - Good experience of biopharmaceutical clinical research - Experience involving a broad exposure to biopharmaceutical clinical development process and procedures - Experience developing and implementing recruitment and retention plans - Experience working independently across departments within a team/matrix environment -Detailed knowledge of international clinical research and drug development - Strong understanding of program and study operations in an international setting -Relevant therapeutic area(s) - Strong computer literacy, including word processing, presentation, spreadsheet and project management applications - Organizational change management process2012-05-21 18:10:58United StatesAmgenCalifornia15617BRCAThousand Oaks, CA28832988http://www.amgen.jobs/xml/28832988/jobUSAThousand OaksAuto req 15771BR Job Posting Title Biostatistical Programming Mgr Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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 . The Biostatistical Programming Manager is responsible for: • 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 • Writing and/or reviewing statistical programming plans and dataset specifications. • Ensuring the analysis and presentation of biomedical data is accurate and complete. • Adherence to Amgen Policies, SOPs and other controlled documents Basic Qualifications • Bachelor’s degree & 5 years of directly related experience Preferred Qualifications • MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject • Biostatistical Programming using the SAS System • Drug Development (pre-, early, late and/or observational) in related industries or academic research • Project planning • Process improvement participation • International co-operation • Team participation and effectiveness • Six (6) years relevant career experience2012-05-20 19:44:41United StatesAmgenCalifornia15771BRCAThousand Oaks, CA28824683http://www.amgen.jobs/xml/28824683/jobUSAThousand OaksAuto req 15636BR Job Posting Title Sr Assoc Clinical Trial Mgmt Systems Career Category Clinical Employee Subgroup Hourly FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Review and track global organizational performance metrics Highlight performance gaps and identify root cause; recommend meaningful improvement opportunities Co-ordinate the creation and distribution of metrics reports and other status reports as required Manage benchmarking efforts Initiate and build relationships with study teams and business partners to understand study requirements Develop protocol builds and budgets to meet study team requirements Partner with appropriate Dev IS resources on CAAS tools to meet client needs Collaborate with appropriate Dev IS resources of other systems to ensure consistency of data standards and quality Create and distribute written materials to support training, data integrity, or other special projects (as assigned) Provide clients with outstanding support through effective communications and robust processes Lead special projects as assigned Gather stakeholder requirements on applications, metrics and reports Develop processes and reporting to ensure compliance to data standards and compliance to business processes Basic Qualifications Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications BA/BS/BSc in the sciences or RN Specialist work experience in business support role in the life sciences or medically related field 5 years work experience in life sciences or medically related field, including 2 years of clinical development experience involving clinical applications (e.g. CTMS, IVRS, EDC2012-05-18 18:07:27United StatesAmgenCalifornia15636BRCAThousand Oaks, CA28792892http://www.amgen.jobs/xml/28792892/jobUSASouth San FranciscoAuto req 15588BR Job Posting Title CDM Systems Mgr Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen 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. The 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. Key Responsibilities include: • Lead study level system requirements meetings with internal and external clients • Design and oversee the development of study specific technical documents • Document possible risk and implement mitigation plans • Manage project related timelines and associated activities • Identify and track study-related technical issues to resolution • Provide a supportive framework for continuous process and quality improvements Other responsibilities include: • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Provide feedback on clinical protocols as it relates to electronic solutions and ensure the use of data standards and adoption of configurable modules • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • Develop strong relationship with external providers (such Vendor Providers) and utilize strong negotiation skills to ensure a delivery of CDM Systems deliverables Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications 5 years of experience implementing clinical systems, such as CTMS, EDC, IVRS, IWRS, ePRO or other related technology in the pharmaceutical/biotechnology industry 3 years of biopharmaceutical clinical research experience Candidate will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • 6+ or more years of experience in a technical role within clinical data management, clinical development, clinical setting, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and IVR and IWR systems • 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 • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Working knowledge of Good Clinical Practices and Global Regulatory regulations as applicable • Previous line management experience2012-05-17 20:57:32United StatesAmgenCalifornia15588BRCASouth San Francisco, CA28771038http://www.amgen.jobs/xml/28771038/jobUSAThousand OaksAuto req 15711BR Job Posting Title Medical Information Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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’s innovative scientific programs. Primary responsibilities include providing verbal and written clinical and technical information to internal and external customers as it relates to Amgen’s 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. Additional 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. Key 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. Basic Qualifications ?Doctorate degree OR ?Master’s degree & 3 years of directly related experience OR ?Bachelor’s degree & 5 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience Preferred 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. Strong 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.2012-05-16 19:08:46United StatesAmgenCalifornia15711BRCAThousand Oaks, CA28737812http://www.amgen.jobs/xml/28737812/jobUSAThousand OaksAuto req 15705BR Job Posting Title CDM Systems Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The Manager of Client System Services – 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. This 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’s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization. Mentor and support junior staff • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • 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 Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT • Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery • Previous experience working in a global environment • Previous Data Manager in clinical development setting or study team related experience • Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable • 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 • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable2012-05-16 19:07:37United StatesAmgenCalifornia15705BRCAThousand Oaks, CA28737777http://www.amgen.jobs/xml/28737777/jobCANNoneAuto req 15700BR Job Posting Title Sr Associate Contract Management (Contract) Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) Canada Location (City) Mississauga Amgen Job Description Position: Senior Associate Clinical Contracts & Budgets Reports to: Manager, Clinical Research Services Grade: 4 Starting:August 2012 (13-month maternity-leave contract) Location: Head Office, Mississauga Internal Candidates are required to have a discussion with their current manager regarding intent to apply. Job Purpose: To manage all site-related contracting and budget negotiations and to process and track related payments in a timely and efficient manner. Key Job Functions: 1. 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 2. Leads the review of the budget template with local project manager for country feedback on FMV (Fair Market Value) and the Schedule A template 3. Negotiates site budget from the base budget and payment milestones using appropriate guidelines 4. Escalates contract/budget issues to Legal, Pricing, and/or local & global study manager as appropriate 5. Coordinates and participates in meetings with site/legal to resolve contract issues 6. Manages, executes and reconciles payments ensuring that spending is within approved contract budgets 7. Maintains contract and payment data tracking in appropriate databases and financial systems 8. Manage internal stakeholder needs and expectations through regular communication regarding progress/status of pending contract and payment requests. 9. Actively contributes to results-oriented global and local departmental goals 10. Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness Basic Qualifications Qualifications/Experience • Bachelor’s degree in a science or business field • 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 • Work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO is preferred. Competencies • Ability to work independently with little supervision as well as in a team environment • Strong Negotiation skills • Strong analytical and presentation skills • Excellent written and oral communication skills • Attention to detail • Persistent, tactful and persuasive • Proficiency with computer/database systems • Strong organizational skills with the ability to manage multiple priorities2012-05-11 18:20:30CanadaAmgenNone15700BRNoneVirtual, CAN28633380http://www.amgen.jobs/xml/28633380/jobCHEZugAuto req 15674BR Job Posting Title Senior Associate Clinical Operations Management Career Category Clinical Employee Subgroup Invoice Paid FT Country (State/Region) Switzerland Location (City) Zug Amgen 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: Contribute to the design and preparation of the draft informed consent template, ensuring Local content is added Assist in the conduct of feasibility assessments for new clinical protocols if required Contribute to the identification and selection of clinical investigators Work with the Clinical Operations Managers (COM’s) and Senior Associate Clinical Operations Management (SACOMs) colleagues to formulate a comprehensive recruitment plan for each new project. Contribute to the development of study specific processes including study communication plans Participate in identifying study related issues, and work with the COM and MCFO to initiate corrective actions when necessary With the study-specific COM, plan and conduct monthly project review meetings in order to update all Managers on study progress, issues and planned resolutions. Participate in local team meetings, task forces and liaise with Global Study Team if required Identifying and reviewing process issues within the clinical development group and recommending improvements when required Accompany CRA in site evaluations, initiations, monitoring and close out if required. Act as back up to COMs when required Coordinate & actively participate at local investigators meetings Review CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) For studies with sole project management responsibility (eg Phase 4, follow up and extension studies) Basic Qualifications BA/BS/BSc or qualified nurse (RN) Work 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) Preferred Qualifications Project management experience in life sciences or medically related field obtained working on clinical trials in a biotech, pharmaceutical or CRO company Operational performance measurement experience International collaboration experience2012-05-09 20:33:38SwitzerlandAmgenNone15674BRNoneZug, CHE28581226http://www.amgen.jobs/xml/28581226/jobUSAThousand OaksAuto req 15649BR Job Posting Title Clinical Research Medical Dir Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Medical Director (Biosimilars) is responsible for: • Supporting the development, execution and communication of the global clinical plan • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program • Participating and providing clinical input into safety and regulatory interactions • Supporting the development of key scientific external relationships with opinion leaders Key Activities • Provide clinical/scientific input during the development and execution of clinical trials • Interpret clinical trial data • Participate in safety assessments • Participate in interactions with regulatory agencies • Author regulatory submissions and publications • Develop key opinion leaders and make scientific presentations • Support in-licensing and partner relationships • Support product lifecycle management Basic Qualifications • MD with clinical experience in Oncology • Three (3) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company Preferred Qualifications • MD plus accredited residency in Oncology, board certified or equivalent • 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 • Experience in all phases of clinical research (Phase 1-4) • Experience interacting with FDA and international regulatory agencies • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • Familiarity with concepts of clinical research and clinical trial design, including biostatistics • Sound scientific and clinical judgment • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication • Demonstrated ability as a medical expert in a complex matrix environment • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-05-07 18:07:01United StatesAmgenCalifornia15649BRCAThousand Oaks, CA28478115http://www.amgen.jobs/xml/28478115/jobUSAThousand OaksAuto req 15618BR Job Posting Title Epidemiology Sr Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Job Summary The 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. This position will be located at Amgen's Thousand Oaks headquarters. An 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’s mission. Key Activities Include • Contributes to research strategy within the product team and observational research TA • Responsible for conducting high-quality observational research to support product strategy within TA • Executes safety-related analyses/studies • Provides support for safety surveillance across the life cycle of Amgen products • Support preparation of PSRM materials • Executes process of patient exposure estimation for marketed products • Supports development of risk management plans • Plans and conducts database analyses to answer key questions with the product teams • Collaborates with Health Economics colleagues to generate evidence to support the value plan • Participates in cross-functional teams to develop the research strategy for products and conducts the observational research • Supports relationships with key leaders in observational research • Sets annual product-specific and personal goals • Provides input into observational research department meetings • Stays abreast of the latest developments in the field of observational research and drug development and contributes to the field • Promotes observational research awareness • Promotes understanding and use of state of the art observational research methods • Communicates significant scientific information to a variety of audiences Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master’s degree & 6 years of directly related experience OR Bachelor’s degree & 8 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Preferred Qualifications • PhD degree in Epidemiology or Medical degree with observational research experience • 6 or more years experience in observational research • Record of publications in peer-reviewed journals • 3 years experience with Medical or Doctoral degree • Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting • Experience in research to support drug development • Experience in observational research project planning and management • Experience communicating observational research information (written and oral) • Experience working in multi-disciplinary teams • Managerial experience Knowledgeable in • Basic observational research study designs and analysis • Programming in SAS or other software (e.g. STATA) • Literature search methods • Observational research methodology and applications within Drug Development • Drug development process and operations • Observational research databases • Knowledge of adverse drug experience data2012-05-07 18:05:15United StatesAmgenCalifornia15618BRCAThousand Oaks, CA28478106http://www.amgen.jobs/xml/28478106/jobUSASeattleAuto req 15562BR Job Posting Title Sr Associate Biostatistical Programming Career Category Clinical Employee Subgroup Hourly FT Country (State/Region) United States - California United States - Washington Location (City) Seattle South San Francisco Thousand Oaks Amgen Job Description Position can be filled in Thousand Oaks, CA, San Francisco, CA or Seattle, WA •Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan, NONMEM specifications •Write, 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 •Understand and execute department-, product- and study-level macros and utilities •Write, test and validate product- and study-level macros and utilities •Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings •Provide input to and participate in intra-departmental and GBDS meetings •Contribute to the continuous improvement of Global Biomedical Data Sciences (GBDS) and programming •Assist in the review of GBDS policies, standard operating procedures and other controlled documents •Provide support to and mentor more junior programmers •Interface with outsourcing partners and vendors •Attend external professional organizations, conferences, training and/or meetings Knowledge •Computer programming, preferably SAS or other procedural languages •Fundamentals of Project Planning and Management •Drug Development Process & Operations Basic Qualifications •BS/BSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject •Three (3) years relevant career experience Preferred Qualifications •MS degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject •Drug Development (pre-, early, late and/or observational) in related industries or academic research •Four (4) years relevant career experience2012-05-03 18:01:32United StatesAmgenCalifornia15562BRCASeattle, CA28403680http://www.amgen.jobs/xml/28403680/jobUSAThousand OaksAuto req 15401BR Job Posting Title Clinical Data Mgmt Mgr Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The Clinical Data Mgr’s responsibilities include: Co-ordination and mentoring of lead data managers within assigned projects Leading CDM activities for assigned study teams Ensuring clinical projects are executed according to set timelines with quality and consistency Ensuring that CDM procedures and processes are adhered to Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications Bachelors degree in life science, computer science, business administration or related discipline 6+ years work experience in clinical data management in the Pharmaceutical or Biotech arena 3+ years project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.) Experience working in Medidata Rave 5.x Solid understanding of clinical data handling procedures related to clinical oncology in solid tumor indications2012-04-26 18:19:48United StatesAmgenCalifornia15401BRCAThousand Oaks, CA28203622http://www.amgen.jobs/xml/28203622/jobGBRUxbridgeAuto req 15165BR Job Posting Title International Dev Medical Dir Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description Overview: This is a newly formed role in the International Bone, Neuroscience & Inflammation TA. AMG 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). Key responsibilities: • Implementation and completion of AST’s (Amgen sponsored studies) • Leads development of study protocols for International AST’s; supports and executes international study protocol preparation, filing, review and approval in line with Amgen processes and policies • Ensures that International input is included as appropriate in GSP/GDP and global study protocols and SCD’s • Supports Affiliates in protocol development of Local AST’s and approves Local AST’s prior to IPRC submission (in conjunction with GDO) • Identify/resolve issues related to study design that arise during study execution • Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program • Participates in the development of Global strategies and tactics in close collaboration with the GDL and the International TA Head • Visits selected KOLs and study groups for strategic discussions and protocol development • Reviews International and Local ISS proposals • Partners with the International Brand Directors in the development and execution of the International product(s) lifecycle management plan • Oversees in-sourced/outsourced International medical programs and logistics • Supports regulatory and ethics approvals for Global development studies • Organizes and/or conducts International Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate • Member of respective IBT • Provides medical expertise for pipeline products • Provides medical expertise for Health Economy and reimbursement requests • Chairs the International Medical Team (IMT) Basic Qualifications • Medical degree with deep scientific expertise in Preferred Qualifications • Substantial clinical development experience, preferably from a pharmaceutical or possibly well established biotechnology company • Experience with clinical study management and conduct • Broad and formal leadership experience • Commercial acumen, ideally launch experience • 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 • Therapeutic area knowledge • Network of customer contacts in therapeutic area • Finance and budgeting experience2012-04-24 20:49:23United KingdomAmgenNone15165BRNoneUxbridge, GBR28152716http://www.amgen.jobs/xml/28152716/jobUSAThousand OaksAuto req 14290BR Job Posting Title CDM Systems Manager Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description THIS ROLE CAN BE BASED AT AMGEN’S THOUSAND OAKS, CA OR SOUTH SAN FRANCISCO SITE Serve as primary point-of-contact to coordinate and lead comprehensive and holistic Clinical Data Management system services to Data Management Therapeutic teams. The Manager of Client System Services – 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. This 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’s Data Management operations and systems and work collaboratively with the Thousand Oaks and UK based CDM teams and stakeholders enabling operational effectiveness and utilization. Other responsibilities include: • Mentor and support junior staff • Ensure quality deliverables to systems implementations to standard operating procedures and regulatory agency guidelines. • Procurement and program management of resources, timeline, and services from both internal and external service providers • Provide technical expertise and leadership by partnering with Global Lead Data Managers to utilize the CDM Systems services and technology • Build effective relationships and partnerships with Global Development Operations, IS, Global Statistical Programming, Quality Assurance, and other key stakeholders and service providers • Participate / Lead optimization efforts in operational effectiveness and department or cross company initiatives • Gather and analyze status and performance metric information and ensure performance targets and goals are accomplished • 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 Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT • Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery • Previous experience working in a global environment • Previous Data Manager in clinical development setting or study team related experience • Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Medidata RAVE, Oracle Siebel eClinical, or Oracle Remote Data Capture hands on operational and system knowledge desirable • 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 • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable2012-03-14 03:14:47United StatesAmgenCalifornia14290BRCAThousand Oaks, CA27126977http://www.amgen.jobs/xml/27126977/jobUSAThousand OaksAuto req 14150BR Job Posting Title Principal Scientist (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. Basic Qualifications - Doctorate degree & 5 years of scientific experience OR - Master’s degree & 12 years of scientific experience OR - Bachelor’s degree & 15 years of scientific experience Preferred 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 - 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 - 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) - Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities - Leadership quality for effective team building with strong decision making and problem solving skills - Excellent interpersonal, technical, and communication skills that enable effective management and resolution of complex issues involving collaborations within a cross-functional team setting - Project management skills for timeline tracking and resource planning - 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.2012-02-29 22:31:16United StatesAmgenCalifornia14150BRCAThousand Oaks, CA26849248http://www.amgen.jobs/xml/26849248/jobUSASeattleAuto req 14154BR Job Posting Title Director Preclinical (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - Washington Location (City) Seattle Amgen Job Description Amgen, Inc. is seeking a highly motivated candidate for the position of Director in the Quantitative Pharmacology Group of the PKDM Department. The 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. The 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. Basic Qualifications - Doctorate degree & 7 years of scientific experience Preferred 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 - Experience as PKDM/Clinical Pharmacology functional representative on product development teams - Experience with PK and PK/PD data analysis, interpretation, and reporting for small molecule and/or protein therapeutics - Hands-on experiences in population PK/PD modeling and simulations (M&S) - Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities - R&D experience in oncology therapeutics, inflammation and/or metabolic therapeutic areas - Leadership quality for effective team building with strong decision making and problem solving skills - Excellent interpersonal, technical, and communication skills to lead a group of quantitative pharmacology scientists - Excellent problem scoping, planning and business skills necessary to drive decision making and influence senior leadership - Project management skills for timeline tracking and resource planning - Solid publication record as senior author and growing reputation with external peers. - The successful candidate will have strong interpersonal communication and leadership skills.2012-02-29 22:30:57United StatesAmgenWashington14154BRWASeattle, WA26849234http://www.amgen.jobs/xml/26849234/jobUSAThousand OaksAuto req 14148BR Job Posting Title Sr Scientist (Quantitative Pharmacology/PKDM) Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. The 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. Basic Qualifications - Doctorate degree & 2 years of scientific experience OR - Master’s degree & 8 years of scientific experience OR - Bachelor’s degree & 10 years of scientific experience Preferred 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 - Specialized in PK/PD modeling and population-based analyses/simulations (hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc). - Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) - 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. - Knowledge of PK and PK/PD for small molecule and/or protein therapeutics. - Leadership quality for effective team building with strong decision making and problem solving skills - Experience in authoring regulatory documentation (IND, IMPD, CTX, etc) and interaction with regulatory authorities. - Experience as PK/PD lead on discovery or development project teams in Neurosciences, Cardiovascular, or other therapeutic areas.2012-02-29 22:30:55United StatesAmgenCalifornia14148BRCAThousand Oaks, CA26849231http://www.amgen.jobs/xml/26849231/jobUSAThousand OaksAuto req 14147BR Job Posting Title Clinical Research Sr Medical Scientist - Cardiology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Clinical Research Sr. Medical Scientist is responsible for: - Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Participating and providing clinical input into safety and regulatory interactions - Provide clinical/scientific input during the development and execution of clinical trials - Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols) - Interpret clinical trial data - Participate in safety assessments - Review and provide clinical scientific input to TLGs and safety narratives - Review scientific literature - Initiate database analyses to support commercial/clinical objectives - Contribute to the preparation of clinical study reports and regulatory submissions - Participate in interactions with regulatory agencies - 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 - Identify new clinical research opportunities Knowledge: - Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Medical knowledge in the relevant therapeutic area - Sound scientific and clinical judgment - Familiarity with regulatory agency organization, guidelines, and practices - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Basic Qualifications M.D. degree Preferred Qualifications - M.D. plus accredited residency in Cardiology, board certified or equivalent - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities2012-02-29 22:29:59United StatesAmgenCalifornia14147BRCAThousand Oaks, CA26849201http://www.amgen.jobs/xml/26849201/jobUSAThousand OaksAuto req 13564BR Job Posting Title Clinical Research Medical Director - Hematology / Oncology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Medical Director will work within the Hematology/Oncology Therapeutic Area. The responsibilities for this role include: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - Experience in clinical research in hematology and/or oncology2012-02-16 21:58:36United StatesAmgenCalifornia13564BRCAThousand Oaks, CA26576276http://www.amgen.jobs/xml/26576276/jobUSAThousand OaksAuto req 13963BR Job Posting Title Principal Scientist Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Basic Qualifications • Doctorate degree & 5 years of scientific experience OR • Master’s degree & 12 years of scientific experience OR • Bachelor’s degree & 15 years of scientific experience Preferred Qualifications •Ph.D in life sciences and 2+ years of post-doctoral experience and 4+ years of industry experience. •Experience in the discovery and implementation of biomarkers within clinical studies for cardiovascular disease (e.g. lipid regulation, dyslipidemia, atherosclerosis). •Strong desire to be part of the flexible and dynamic environment of early development, and be capable of supporting a broad portfolio of novel projects. •A strong background in cardiovascular biology, with emphasis on the understanding of pathway interventions applied as therapeutics. •Strong skills in critical thinking, laboratory experimentation and analysis, and understanding of the advantages and limitations of exploratory analyses in the clinical setting. •Effective communication and interpersonal skills and the ability to work in a matrix environment are essential.2012-02-15 22:00:25United StatesAmgenCalifornia13963BRCAThousand Oaks, CA26547305http://www.amgen.jobs/xml/26547305/jobUSAThousand OaksAuto req 13910BR Job Posting Title Medical Sciences Medical Dir - Oncology Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Medical Sciences Group is looking for a strong leader in Hematology/Oncology. The 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’s Product Strategy Teams through their role as an Early Development Leader (EDL). This 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. In addition, the candidate will have the following responsibilities: Serve as an internal clinical expert in translational and clinical oncology. Serve as medical monitor for clinical trials and assists in resolving major issues that may affect the studies. Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams. Coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources. Provide 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. Ensure appropriate training, recruitment, and development requirements for matrix team resources. Basic Qualifications •MD •Two(2)or more years of clinical research and/or basic science research experience Preferred Qualifications •MD plus accredited residency in Oncology and/or Malignant Hematology, board certified •MD/PhD and a strong basic science or clinical research background in academics or pharma •Effective presentation and communication abilities (both written and oral) •Ability to anticipate problems and find creative solutions •In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale •A record of high quality peer-reviewed publications •Experience functioning as a medical expert in a complex matrixed environment •Previous experience in early phase development and/or biomarker work is a strong plus2012-02-15 21:59:43United StatesAmgenCalifornia13910BRCAThousand Oaks, CA26547283http://www.amgen.jobs/xml/26547283/jobUSAThousand OaksAuto req 13888BR Job Posting Title Medical Sciences Medical Dir Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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’s early development pipeline. Basic Qualifications • MD • 3 years clinical trial experience in industry and/or academic setting Preferred Qualifications • Residency in Internal Medicine or related discipline • Subspecialty fellowship training in Clinical Pharmacology, or an Internal Medicine subspecialty, with a background in translational medicine • Experience interacting with or serving on an IRBs or Ethics Committees • Board certification or eligible • M.D./Ph.D. in biological science • Excellent oral and written communication skills • Excellent interpersonal skills • Experience in early clinical trials • Solid understanding of GCP and Healthcare Compliance • Experience in basic research and clinical trial methodology • Publication track record • Ability to lead, manage and motivate teams2012-02-14 20:00:48United StatesAmgenCalifornia13888BRCAThousand Oaks, CA26520634http://www.amgen.jobs/xml/26520634/jobUSAThousand OaksAuto req 13890BR Job Posting Title Principal Scientist - PKDM Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen 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. Basic Qualifications •Doctorate degree & 5 years of scientific experience OR •Master’s degree & 12 years of scientific experience OR •Bachelor’s degree & 15 years of scientific experience Preferred Qualifications •PhD 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 •Specialized in PK/PD modeling and population-based analyses/simulations with established track-record records of model-based drug development •Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations. •Leadership quality for effective team building with strong decision making and problem solving skills •Excellent interpersonal, technical, and communication skills to lead cross-functional teams •Candidate with R&D experience to support small and/or large molecule oncology therapeutics •Demonstrated experience with modeling and simulation software (e.g. NONMEM, SAS, S-Plus, Pharsight Clinical Trial Simulator) •Excellence and eminence in field of PK/PD and modeling & simulation with peer-review articles and external presentations.2012-02-10 18:17:40United StatesAmgenCalifornia13890BRCAThousand Oaks, CA26456588http://www.amgen.jobs/xml/26456588/jobUSAThousand OaksAuto req 13870BR Job Posting Title Clinical Research Medical Director - Oncology - Xgeva Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This Clinical Research Medical Director is responsible for: - Supporting the development, execution and communication of the global scientific/medical evidence plan - Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program - Supporting the development of key scientific external relationships with opinion leaders - Participating and providing clinical input into safety and regulatory interactions Key Activities: - Provide clinical/scientific input during the development and execution of clinical trials - Interpret clinical trial data - Participate in safety assessments - Participate in interactions with regulatory agencies - Author CSRs, publications and regulatory submissions - Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL - Identify new clinical research opportunities - Support in-licensing and out-licensing activities and partner relationships - Support product lifecycle management for new indications as directed by Global Development Leader - Provide clinical content input to: - Regulatory interactions and documents - Safety interactions and documents - Materials to be used in Scientific Affairs - Materials to be used by the Commercial Organization Basic Qualifications - MD - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Preferred Qualifications - MD plus accredited residency in relevant sub-specialty, board certified or equivalent - Experience in GU Oncology - Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities - Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) - prior oncology clinical research / experience Knowledge - In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale - Familiarity with concepts of clinical research and clinical trial design, including biostatistics - Sound scientific and clinical judgment - Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements - Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication - Demonstrated ability as a medical expert in a complex matrix environment - History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues2012-02-09 23:44:48United StatesAmgenCalifornia13870BRCAThousand Oaks, CA26445010http://www.amgen.jobs/xml/26445010/jobUSAThousand OaksAuto req 12729BR Job Posting Title Biomedical Data Stewardship Sr Manager Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description • 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. • Lead the Global Standardized Data Presentation Governance Committee • Lead the continuous improvement of data presentation processes and supporting technology Responsibilities: • Ensuring best data presentation practice through leadership of cross-functional Global Standardized Data Presentation Governance Committee • Maintaining compliance and compatibility with CDISC standards particularly ADaM. • Contributing to the development and strategy of the GBDS Data Stewardship organization Key Activities: • Collaborate cross-functionally and within GBDS Data Stewardship to drive forward compliance with standards, processes and training • Track key metrics and reporting to GBDS and R&D Senior Management • Lead, motivate and develop the Global TFL Committee • Develop and maintain strong working relationships with key stakeholders Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Bachelors degree in statistics/ biostatistics, programming, life science, computer science - 8 years work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena - 3+ years experience in a global organization - Demonstrated ability to influence decision making - Development of policies and SOPs - Experience collaborating on global cross-functional teams - Knowledge of project management, documentation writing, training, and compliance - Interest in process improvement methodologies - Use of software and data applications within drug development - Appreciation of computer system architecture and hardware2011-11-28 21:33:28United StatesAmgenCalifornia12729BRCAThousand Oaks, CA25067075http://www.amgen.jobs/xml/25067075/jobUSASouth San FranciscoAuto req 12764BR Job Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations Career Category Clinical Development Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) South San Francisco Thousand Oaks Amgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site. The CDM Systems Mgr – EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen’s 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. The 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. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience OR Associate’s degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications • 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements • Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm • Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable • Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary • Knowledge of ITIL v3 and basic Industry IS best practices • Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills • Excellent time management and organization skills required • Must have sound problem resolution, judgment, and decision-making abilities • Must be able to work well in a global team-based matrix environment with minimal supervision • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable • 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. The 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’s 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.2011-11-28 21:31:18United StatesAmgenCalifornia12764BRCASouth San Francisco, CA25067023http://www.amgen.jobs/xml/25067023/job