Amgen Jobshttp://www.amgen.jobs2012-05-26 15:09:25.786539USAThousand 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/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/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 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 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