Global Medical Affairs Lead - Leukemia Pipeline
The Global Medical Affairs Lead (GMAL) is accountable for the development and execution of global medical affairs strategy for Amgen's pipeline portfolio of early assets in Acute Myeloid Leukemia, including evidence generation, communication, and global external engagement.
The Global Medical Affairs Lead (GMAL) for Leukemia Pipeline will:
- Gather clinical insights and translate them into actionable strategies
- Facilitate scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and medical value of Amgen's pipeline portfolio of assets in AML
- Serve as a core member of the Evidence Generation Team, partner with Global Development Leads on evidence generation activities, and ensure the Evidence Generation Plan addresses key regional/local needs.
- Develop Potential Area of Scientific Interest (PASI) for Investigator Sponsored Studies (ISS), and approve competitive grants, if applicable
- Provide strategic direction for study design and execution for global medical affairs studies
- Represent medical perspective on Product Team and other teams, as necessary
- Enable access to medicines through clear understanding and education of treatment value in partnership with cross-functional stakeholders
- Establish strategy for medical communications and related activities, e.g., product narrative, scientific platform, core content, publications, medical education, and congresses
- Develop global medical strategic plan and ensure consistent execution of outputs through the Global Medical Affairs Teams (GMAT)
- Contribute to Amgen's Global Safety and global Benefit/Risk profile of a molecule and ensure communication of the implications to external stakeholders
- Facilitate and continue to build Amgen's role as a science-based, patient-focused partner
- Contribute to Advisory Board development and execution
- Contribute to Global Value Dossier
- Determine resource and budget allocation necessary to deliver on global medical strategy
MD/DO degree from an accredited medical school OR PhD OR PharmD
4 years of Medical Affairs experience or related experience in Hematology-Oncology
Clinical and disease knowledge base in AML
- MD plus accredited fellowship in Hematology-Oncology, board certified or board eligible
- 5 years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
- 2 years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
- Experience with stakeholder engagement and interactions (e.g., OLs, advocacy groups, payers)
- Familiarity with global regulatory organizations, guidelines, and practices
- Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
- History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
- In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale
- Track record of success working with matrixed cross-functional teams
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.