Senior Medical Scientist - Global Medical - Hematology

The Global Medical Senior Medical Scientist supports the implementation of Global Medical strategies, including Global launch and lifecycle management.

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Responsibilities:

• Supporting the development and execution of Global product medical strategy, via the Global 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
  • 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:

• Participates in development of Global cross functional strategy and supports medical execution
• 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)
• Provides input into medical and scientific insight for incorporation into Global product strategies, via the Global 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 Global evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy
• Supports product-specific Global 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 human subject safety for marketed product in cooperation and effective partnership with responsible functions (e.g. GRAAS, Global Development)
• Actively participates in Global 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

Basic Qualifications

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

Preferred Qualifications

• Accredited fellowship in hematology/oncology, board certified or board eligible
• 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 Global health care compliance considerations
• Experience with opinion leader interactions
• Experience with integrated delivery networks, accountable care organizations, and payers
• Broad and formal leadership experience

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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