Career CategoryMedical Affairs
Job DescriptionSenior Director, Medical AffairsWhat you will doLet's do this. Let's change the world. In this vital role, the Senior Director Medical Affairs will be accountable for the development and execution of the global medical affairs strategy across the Hematology portfolio, including marketed products, lifecycle opportunities, and pipeline assets, ensuring alignment with enterprise, development, and commercial priorities. The Asset Lead Medical Director will lead the Global Medical Affairs Hematology Team with the objective of maximizing Amgen's medical value proposition, advancing evidence generation, and enabling the successful development and lifecycle management of the hematology assets.
Responsibilities- Lead, coach, and develop a high-performing global medical hematology team, fostering talent development, succession planning, and organizational effectiveness.
- Lead the cross-functional and cross-regional development and execution of the global medical affairs strategy for the assigned asset through the Global Medical Affairs Team.
- Serve as the senior Medical Affairs leader for hematology representative on relevant global strategic, governance, and cross-functional teams, shaping the long-term scientific, evidence-generation, and stakeholder engagement strategy across the therapeutic area.
- Support the development and delivery of the clinical development plan, integrated evidence generation plan, and lifecycle strategy for the assigned asset and/or follow-on indications.
- Actively provide medical and scientific insights to support development of the Target Product Profile and asset strategy.
- Capture clinical, scientific, patient, payer, and health system insights across key markets and translate them into concrete strategies and medical plans.
- Coordinate with regions to develop and lead the external stakeholder management plan, communication strategy, scientific platform, publication plan, and evidence generation plan.
- Develop robust external stakeholder engagement and insight-gathering approaches to strengthen understanding of unmet need and maximize the medical value of the asset.
- Facilitate scientific engagement with a broad range of external stakeholders, including opinion leaders, professional organizations, advocacy groups, payers, regulators, and other healthcare decision makers.
- Provide strategic direction for study design and execution for medical affairs studies and other global evidence-generation activities.
- Partner on evidence generation and ensure key regional and local needs are addressed.
- Align and implement medical communication strategies and related activities, including review, approval, and dissemination of medical communications as appropriate.
- Provide input into value dossiers and support activities that enable access to medicines through clear understanding and communication of treatment value.
- Determine resource and budget allocation necessary to deliver on medical strategies.
- Cultivate collaboration and coordination across medical functions, regions, and cross-functional partners.
- Facilitate and continue to build Amgen's role as a science-based, patient-focused partner.
- Provide insights to support Amgen's understanding of the safety and benefit/risk profile of the molecule.
- Lead or support advisory boards, congress activities, and other scientific meetings.
- Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvement.
- Ensure all medical activities are conducted in full compliance with applicable laws, regulations, guidelines, and Amgen policies and procedures.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a strategic leader with these qualifications.
Basic QualificationsDoctorate degree and 5 years of medical affairs or clinical development experience in the relevant therapeutic area
ORMaster's degree and 8 years of medical affairs or clinical development experience in the relevant therapeutic area
ORBachelor's degree and 10 years of medical affairs or clinical development experience in the relevant therapeutic area
Preferred Qualifications- MD/DO degree from an accredited medical school, PhD, or PharmD.
- MD plus accredited fellowship or equivalent advanced training in a relevant specialty.
- Board certified or board eligible, where applicable.
- 5+ years of clinical research and/or medical affairs experience in a leadership role.
- Minimum of 5 years of Medical Affairs experience in the biopharmaceutical industry, including biotechnology, pharmaceutical, or CRO experience.
- Demonstrated expertise in malignant hematology, including leukemia, lymphoma, myeloma, or related disorders, with a strong understanding of evolving treatment paradigms and competitive landscapes.
- Experience building and executing Integrated Evidence Generation Plans.
- Demonstrated ability to lead through influence in a matrixed, cross-functional, and cross-regional environment.
- Ability to establish effective interactions and engagements with external stakeholders, including opinion leaders, advocacy groups, patients, payers, vendors, professional organizations, and other healthcare decision makers.
- Familiarity with global regulatory organizations, guidelines, and practices.
- Knowledge of Good Clinical Practices, global regulations, and applicable medical affairs guidelines.
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including clinical operations, commercial, regulatory, safety, access, and medical affairs.
- Strong understanding of healthcare systems around the world, including the U.S., Europe, and Asia.
- History of solving complex problems while exhibiting sound scientific and medical judgment and a balanced, realistic understanding of issues.
- Track record of success working with matrixed cross-functional teams.
- Excellent communication, collaboration, strategic planning, and executive presence.
- Ability to synthesize complex scientific, clinical, and business information into clear medical strategies and actionable plans.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range240,359.60USD -325,192.40 USD
