Medical Sciences Medical Dir - United States
They define, design, and execute early phase clinical and translational projects as the initial strategy for drug development. They typically serve as project leaders for one or more of Amgen’s Product Strategy Teams through their role as an Early Development Leader (EDL). These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
This role will include 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.
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.
Evaluate external opportunities for partnering or licensing new oncology assets
This position can be located in either Thousand Oaks, CA, or San Francisco, CA.
Two (2) or more years of clinical research and/or basic science research experience
Subspecialty board eligibility/certification in Oncology and/or Hematology
Strong basic science or clinical research background in academia or industry
Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
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 including working knowledge of biomarker methods and clinical imaging endpoints
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
Previous experience in late stage oncology clinical trials and regulatory filings
Demonstrated expertise in conducting translational and/or clinical oncology research.
Expertise in Spotfire or other data analysis tools
Knowledge of GCP, EMA, and FDA policies
Expertise in authoring clinical sections of CTA or INDs
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.