Amgen

Medical Director - US Medical Affairs - Cardio (Repatha)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 19, 2019
Ref
R-72413
Required Education
Masters Degree/MBA
Position Type
Full time
The US Medical Director for Repatha supports the implementation of US Medical strategies, including US launch and lifecycle management.

The US MD is responsible for:

  • Supporting the development and execution of US product medical strategy, via the US Medical Plan, including lifecycle management, in collaboration with Product Team and alignment with Global strategy
  • Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
  • Participating in engagement of external key stakeholders (in partnership with other functions)
  • Participating in development of data communication strategy (including congress)
  • Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • Ensuring appropriate medical support of compliance


Key Activities:

Maximizes Amgen's value proposition of respective product(s) through management and delivery of all medical and scientific activities, including lifecycle management, in alignment with Global strategy and Evidence Generation Team (EGT)
  • Participates in development of US cross functional strategy and supports medical execution.
  • Provides input into medical and scientific insight for incorporation into US product strategies, via the US Medical Plan, and provides insights into Global strategies, plans and tactics as a participant in the Commercialization process
  • Ensures understanding and incorporation of patient perspectives in all activities
  • Executes product-specific US evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy
  • Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P
  • May participate in speaking engagements that represent Amgen to external and internal bodies on medical and scientific issues related to relevant product(s)

Supports or implements external Stakeholder Strategy
  • Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders
  • Participates in advocacy from a medical perspective in partnership with Commercial, Government Affairs and GRAAS policy
  • Builds Amgen's reputation as a science-based and patient-focused reliable partner

Ensures appropriate medical leadership of compliance; accountable for the conduct of medical activities according to all relevant compliance standards, regulations and SOP`s; Role models appropriate and compliant behaviors and contributes to creating a climate of compliance adherence across the organization

#LI-POST

MD01

Basic Qualifications

MD/DO degree from an accredited medical school

AND

2 years of medical affairs, clinical/biomedical research experience and/or basic science research

Preferred Qualifications
  • MD plus accredited fellowship, board certified or board eligible
  • PhD with extensive experience in the cardiometabolic space; expertise in real world data/observational research will be appreciated
  • Experience in US cardiovascular medicine
  • Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with clinical study management and conduct
  • Familiarity with US health care compliance considerations
  • Experience with opinion leader interactions
  • Experience with integrated delivery networks, accountable care organizations, and payers
  • Broad and formal leadership experience
  • Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
  • Network of customer contacts in therapeutic area
  • Knowledge of local pharmaceutical industry and legal/health system environment
  • Finance/budgeting and resource management experience


Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.

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.