Medical Director - Medical Affairs - Neurology
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Medical Director - Medical Affairs - NeurologyLive
What you will do
Lets do this. Lets change the world. Reporting to the Aimovig Medical Lead, the Neurology Medical Affairs Director will support the development and execution of the medical affairs strategy for Amgens Aimovig asset (including evidence generation, medical communication, and external engagement), with a focus in the US.
- Support the development and delivery of medical strategies that maximize the value proposition of Aimovig including annual planning and goal setting, launch support and lifecycle management, in collaboration with Medical Asset Lead and/or Medical TA Head, appropriate cross-functional teams and governance
- Synthesize and integrate insights to deliver medical inputs into relevant cross-regional/functional strategies, including relevant brand strategy
- Foster and enhance collaboration and coordination across medical functions
- Contribute to strategy development for scientific engagement across a broad range of partners to strengthen external understanding of the unmet need and value of the product
- Lead/support relationships with the external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate
- Develop and lead/support execution of medical evidence generation that shapes product and informs the practice of medicine, ensuring key needs are met in alignment with global and local medical & relevant brand strategy
- Support appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations; contribute to the development of data interpretation, analysis and communication for medical executed studies
- Facilitate Investigator Sponsored Studies through Amgen governance
- Partner with/support Global Regulatory Affairs and Safety (GRAAS) in product risk management/minimization activities and ensure communication of the implications to internal/external partners
- Provide strategic input into labels/regulatory/reimbursement/policy/promotional materials used to support internal/external interactions
- Determine scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (eg, slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process
- Review, approve and ensure dissemination of medical communications and related activities (eg, product narrative, scientific platform, core content, publications including FPR/FLR, medical education and congresses)
- Lead product/disease state/pipeline specific medical training where appropriate, may deliver training to others
- Lead or support (as appropriate) advisory boards and other relevant meetings (e.g., investigator meetings, and/or expert panels)
- Contribute to the development and/or execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
- Support decisions on IME, donations, medical grants and sponsorships, where appropriate
- In partnership with cross-functional team, ensure informed budget/resource trade-offs, as appropriate (may also develop and manage medical product budget)
- Serve as a medical representative in relevant leadership, governance and cross functional teams
- Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
- Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement
- Foster Amgens reputation as a science-based, innovative and patient-focused reliable partner
What we expect of youBasic Qualifications
- MD/DO degree from an accredited medical school AND 2 years of medical affairs and/or clinical research experience and/or basic science research in Neuroscience
- PhD/PharmD AND 5 years of industry experience in medical affairs or clinical research
- MD plus accredited fellowship in Headache Medicine/Neurology or related medical discipline, 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
- Clinical and disease knowledge base in neurological diseases (particularly migraine/headache disorders)
- 2+ years of clinical or observational research experience and/or basic science combined with clinical teaching and patient care activities
- Experience with stakeholder engagement and interactions (e.g., opinion leaders, 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
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.