Sr Medical Scientist, Medical Affairs, Oncology
Location:
Thousand Oaks , California
Posted:
February 07, 2017
Reference:
R-30660
The US Medical Sr. Medical Scientist for a US Product supports the implementation of US Medical strategies, including US launch and lifecycle management.
This role is responsible for:
Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
Supporting clinical trial conduct
Participating in engagement of external key stakeholders (often in partnership with other functions)
Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
Supports implementation of Medical governance for respective product, which includes:Safety and pharmacovigilance as a key and effective partner with GRAAS
Clinical trial conduct
US risk management/minimization in collaboration with GRAAS
Subject matter appropriateness (medical/scientific) of external interactions (eg. copy review, multichannel, congresses, 1-1 interactions, etc.)
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 launch and 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
Supports product-specific US clinical trial execution
Medical / Scientific contribution to Value Dossiers , compendia and interactions with payers in collaboration with VA&P
Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
May participate in speaking engagements that represent Amgen to external and internal bodies on medical and scientific issues related to relevant product(s)
Participates in the review of investigator sponsored studies
- 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 Medical Governance
Ensures human subject safety for marketed product in cooperation and effective partnership with responsible functions (eg, GRAAS, Global Development)
May support US clinical trial conduct
Participates with the MAC operating committee in the material reviews.
Actively participates in US risk management/minimization in collaboration with GRAAS
May decide subject matter appropriateness (medical/scientific) of external interactions (eg. copy review, multichannel, congresses, 1-1 interactions, etc.)
- 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
Basic Qualifications
MD
Preferred Qualifications
Accredited fellowship in Oncology or Hematology
Board certified or board eligible
Pharmaceutical experience in Medical Affairs
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
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.


A little about us:
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