Clinical Research Medical Director - Oncology
Category: Clinical Development Job ID: R-102300 Location: Thousand Oaks, CA, US 91360 Additional Location: Posted Date: 7/27/2020 Amgen’s Global Development team is looking for a Clinical Research Medical Director within Oncology in Thousand Oaks, CA. Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types. Accountabilities · Contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities · Lead the design and development of clinical study protocols · Serve as a member of the Clinical Study Team - Leadership Team (CST-LT) to provide strategic oversite and execution of clinical trials. Responsibilities • Provide medical and scientific leadership for design of clinical studies (traditional & innovative) and contribute to trial execution from Phase 2 through life cycle management o Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication. o Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP). o Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution. o Monitor, analyse, and interpret clinical study data • As a Global Development Representative o Responsible for development of Clinical Development Plan for Ph2 and beyond o Contributes to TPP and GPS development o Contributes to discussions and decision on long-cycle time activities (AC in Ph2, PRO, device, patient voice, TDM, companion diagnostics) o Create development options and present to GDRC, FSC o Responsible for interfacing with TA leadership and extended team to develop options o Responsible for interfacing with CfDA, CfOR, CPMS, etc to bring innovative later dev options • Contribute to the development of overall program clinical strategy, EGP, and program level activities o Identify and evaluate new clinical research opportunities o Contribute to the development of program clinical development strategy and lifecycle management strategies o Participate in interactions with regulatory agencies o Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents o Develop KOL network and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL) o Support review of Investigator Sponsored Studies (ISS) proposals o Provide support to regional and local Amgen sponsored clinical studies, as necessary • Support due diligence for business development activities o Represent Global Development TA to review available confidential clinical data for a given asset/program o In partnership with Commercial and Business Development, champion generation of TPPs (target product profiles) for assets/program under review o Propose GANTT clinical development timelines Basic Qualifications MD degree from an accredited medical school OR PhD AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Medical Doctor or Ph.D. Preferred Qualifications • MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent • Thoracic oncology experience preferred • Eight (8) 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) • Previous management experience Knowledge • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials • Medical knowledge in the relevant therapeutic area • Sound scientific and clinical judgment • Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements • Understanding of new drug commercialization and business practices • Understanding of resourcing and budgeting Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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