Associate Medical Affairs Director
Neurocrine Biosciences
2 months ago
Remote friendly (San Diego, CA)
United States
Medical Affairs
About The Role
- Responsible for the development of medical affairs strategy, planning, and tactical implementation for medical affairs functions, including publication planning, data generation and communication, KOL interactions, knowledge management, medical education, advisory boards, and cross-functional partnership.
- Travel to congresses and other external meetings as necessary.
Your Contributions
- Medical Affairs Planning: Partner with cross-functional stakeholders to develop aligned Medical Affairs Plans; represent and continuously update plans internally; develop a fully referenced scientific platform/lexicon (derivation, MOA, multimodal attributes, and potential to treat disorders with unmet need); gain endorsement from internal/external opinion leaders and educate the organization.
- Data Generation: Identify key areas for IIS, collaborative research agreements, and Phase IV trials; design and direct collaborative research and Phase IV trials; serve on review committees for investigator-initiated and medical education grant requests; provide medical input into clinical development and lifecycle management; collaborate with Clinical Development.
- Data Communication: Develop and execute publication plans with Medical Communications; participate in congress planning (medical education, competitive intelligence); build relationships with KOLs and payers to identify landscape, data gaps, and educational unmet needs and gather feedback; consult internal stakeholders (and potentially external stakeholders).
- Serve as Medical/Scientific Subject Matter Expert: Provide expertise for assigned products (e.g., PRC, health outcomes plans, MSL activities, speaker programs, training, CME grant reviews, and other internal processes).
Requirements
- PhD + 7+ years experience (clinical practice + Medical Affairs or related pharmaceutical consulting) OR
- PharmD + 7+ years experience (clinical practice + Medical Affairs or related pharmaceutical consulting) OR
- MD preferred + 2+ years relevant experience (preferred: clinical practice in Psychiatry, Neurology, or Movement Disorders).
Preferred/Additional Qualifications & Skills
- Internal thought leader with technical/business expertise; solves critical issues innovatively.
- Experience evaluating complex, ambiguous, cross-functional initiatives.
- Strong interpersonal, communication, organizational, and team leadership skills.
- Ability to work independently; prioritize multiple tasks; deliver on time/budget.
- Passion for education and addressing unmet medical needs in Psychiatry or Neurology (or related area).
- Strong specialty knowledge preferred: Neurology, Movement Disorders, Psychiatry (or related).
- Comprehensive knowledge of GCP, ICH, ICJME Guidelines, FDA and other international regulatory requirements.
- Experience engaging internal/external leaders as medical affairs representative.
- Understands the connection of clinical, medical, and business needs; aligns business/scientific goals.
- Working knowledge of budget development; proven project management/problem-solving.
- Strong analytical and writing skills; develops policies/processes.
- Responsible for the development of medical affairs strategy, planning, and tactical implementation for medical affairs functions, including publication planning, data generation and communication, KOL interactions, knowledge management, medical education, advisory boards, and cross-functional partnership.
- Travel to congresses and other external meetings as necessary.
Your Contributions
- Medical Affairs Planning: Partner with cross-functional stakeholders to develop aligned Medical Affairs Plans; represent and continuously update plans internally; develop a fully referenced scientific platform/lexicon (derivation, MOA, multimodal attributes, and potential to treat disorders with unmet need); gain endorsement from internal/external opinion leaders and educate the organization.
- Data Generation: Identify key areas for IIS, collaborative research agreements, and Phase IV trials; design and direct collaborative research and Phase IV trials; serve on review committees for investigator-initiated and medical education grant requests; provide medical input into clinical development and lifecycle management; collaborate with Clinical Development.
- Data Communication: Develop and execute publication plans with Medical Communications; participate in congress planning (medical education, competitive intelligence); build relationships with KOLs and payers to identify landscape, data gaps, and educational unmet needs and gather feedback; consult internal stakeholders (and potentially external stakeholders).
- Serve as Medical/Scientific Subject Matter Expert: Provide expertise for assigned products (e.g., PRC, health outcomes plans, MSL activities, speaker programs, training, CME grant reviews, and other internal processes).
Requirements
- PhD + 7+ years experience (clinical practice + Medical Affairs or related pharmaceutical consulting) OR
- PharmD + 7+ years experience (clinical practice + Medical Affairs or related pharmaceutical consulting) OR
- MD preferred + 2+ years relevant experience (preferred: clinical practice in Psychiatry, Neurology, or Movement Disorders).
Preferred/Additional Qualifications & Skills
- Internal thought leader with technical/business expertise; solves critical issues innovatively.
- Experience evaluating complex, ambiguous, cross-functional initiatives.
- Strong interpersonal, communication, organizational, and team leadership skills.
- Ability to work independently; prioritize multiple tasks; deliver on time/budget.
- Passion for education and addressing unmet medical needs in Psychiatry or Neurology (or related area).
- Strong specialty knowledge preferred: Neurology, Movement Disorders, Psychiatry (or related).
- Comprehensive knowledge of GCP, ICH, ICJME Guidelines, FDA and other international regulatory requirements.
- Experience engaging internal/external leaders as medical affairs representative.
- Understands the connection of clinical, medical, and business needs; aligns business/scientific goals.
- Working knowledge of budget development; proven project management/problem-solving.
- Strong analytical and writing skills; develops policies/processes.