Amgen Clinical Research Medical Director - US Medical Affairs - Inflammation in Thousand Oaks, California

The US Medical Director for Enbrel in the Inflammation therapeutic area 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 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)

  • 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

  • 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 (e.g. 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)

  • 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 (e.g. GRAAS, Global Development)

  • May support US clinical trial conduct

  • Actively participates in US risk management/minimization in collaboration with GRAAS

  • May decide subject matter appropriateness (medical/scientific) of external interactions (e.g. 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

#LI-POST

MD01

Basic Qualifications

MD or DO degree from an accredited medical school

AND

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

Preferred Qualifications

  • Accredited fellowship in Rheumatology, board certified or board eligible

  • 2+ years of medical affairs experience or clinical development experience with deep understanding of medical affairs, 1+ years of which should be from a pharmaceutical or biotechnology company

  • Clinical or research experience in Gastroenterology

  • Broad and formal leadership experience

  • US and/or Global experience

  • 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

Knowledge

  • 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

  • Inflammation knowledge

  • Network of customer contacts in Inflammation

  • Knowledge of local pharmaceutical industry and legal/health system environment

  • Finance/budgeting and resource management experience

  • Track record of leadership

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.

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.