Medical Sciences Medical Director - Early Development Oncology
The Medical Sciences Group is looking for a Medical Director in Hematology/Oncology.
The Medical Director will lead early phase clinical development of oncology compounds from first-in-man studies through proof of concept. They define, design, and execute early phase clinical and translational projects as the initial strategy for drug development. They typically serve as clinical 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/Early Development 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.
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 (preferred), or San Francisco, CA.
MD Degree and 2 years of clinical research and/or basic science research experience
PhD/PharmD and 10 years of clinical research industry experience in Hematology/Oncology
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 committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.