Amgen

Medical Director - Medical Sciences (Oncology)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 19, 2019
Ref
R-80313
Discipline
Science/R&D, Oncology
Required Education
Doctorate/PHD/MD
Position Type
Full time
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. We need collaborative and innovative world-class talent to ensure these molecules become medicines and that they will strive to reach their full potential while helping patients.

To support that effort, the Translational Medicine Group is looking for a Medical Director in Oncology.

The Medical Director will lead early phase clinical development of oncology compounds from first-in-human 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.

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


Basic Qualifications

MD/DO degree from an accredited medical school

AND

2 years of clinical research and/or basic science research experience

Preferred Qualifications
  • 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


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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