Amgen Senior Medical Scientist - Intercontinental - Hematology-Oncology in Thousand Oaks, California

The Senior Medical Scientist (SMS) for a product supports the implementation of Medical strategies, including launch and lifecycle management.

The SMS is responsible for:

Supporting the development and execution of product medical strategy, via the Medical Plan, including launch support and lifecycle management, in collaboration with cross-functional brand team 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

  • 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 Global Medical Affairs Team (GMAT)

  • Participates in development of cross functional strategy and supports medical execution

  • Provides input into medical and scientific insight for incorporation into product strategies, via the 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 evidence generation strategy, in alignment with GMAT, and supports execution of data communication strategy

  • Supports product-specific clinical trial execution

  • Medical / Scientific contribution 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 clinical trial conduct

  • Actively participates in 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

MD01

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Basic Qualifications

MD or DO degree from an accredited medical school OR PhD OR PharmD

Preferred Qualifications

2+ years of medical affairs experience or clinical development experience with deep understanding of medical affairs

1+ years of experience in pharmaceutical or biotechnology company

Region and/or Global experience with Hematology/Oncology therapeutics

Accredited fellowship in respective product, board certified or board eligible

Experience with clinical study management and conduct

Experience with opinion leader interactions

Broad and formal leadership experience

Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including Clinical Operations, Commercial, Regulatory, and Medical Affairs

Knowledge of local pharmaceutical industry and legal/health system environment

Finance/budgeting and resource management experience

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.