Vice President/Senior Vice President, Medical Affairs
VP/SVP, of Medical Affairs will be responsible for designing Medical Affairs strategy and building out the Medical Affairs organization, supporting the transition of the company from Research and Development organization to a commercial organization.
VP/SVP, of Medical Affairs will be responsible for designing Medical Affairs strategy and building out the Medical Affairs organization, supporting the transition of the company from Research and Development organization to a commercial organization. This person will oversee Medical Affairs including development of strategies and supporting execution for sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications, Value Evidence and Strategy, and Patient Advocacy). The VP/SVP has broad experience across multiple functions within Medical Affairs, the ability to interact with senior leadership and cross-functionally, and a proven track record of successful launches in the US and globally.
Responsibilities:
Build Medical Affairs leadership including developing strategic plans, evaluating specific unmet medical needs, and creating results-oriented plans to fill medical product data gaps in rare diseases
Responsible for overseeing the Medical Affairs team, including MSLs, Medical Communication/Publications/Education, Medical Information, Patient Advocacy, Value Evidence and Strategy
Provides medical/clinical expertise to internal (Commercial, Manufacturing, Market Access, Regulatory, R&D, and Legal) and external (healthcare professionals, patients, advocacy groups, etc.) stakeholders
Collaborate with cross-functional teams to drive development plan and brand strategy, ensuring alignment and compliance in messaging and communication strategy
Partner with Clinical Development and Clinical Operations to provide support for Beam-sponsored clinical studies (recruitment, engagement, study design, and endpoint selection)
Partner with R&D and program teams to provide medical input into early pipeline prioritization
Develop and manage clinical advisors and KOL relationships, assist in the selection of outside experts and maintain key relationships around clinical trials, guidelines, and advisory boards
Develops and delivers scientific and medical presentations, organizes and leads medical advisory boards, participates in investigator meetings, provides medical support to commercial advisory boards. Identify relevant medical meetings and congresses; determine appropriate participation
Collaborate with future commercial teams (eg, Sales and Marketing teams) with therapeutic area and drug-related materials, training, and educational updates
Partner with Clinical Development, Regulatory and Pharmacovigilance on execution of Phase IV studies and registries
Create and facilitate submission/review processes for Investigator Initiated Studies (IIS), materials approval, grants, and publications
Qualifications:
MD, PhD, PharmD, or equivalent degree, with 20+ years experience, 15+ in medical affairs – Level will be commensurate with experience
Experience building and leading a Medical Affairs team
Demonstrated ability to present complex scientific and medical information to a range of audiences; ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and approach.
A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices
Excellent interpersonal skills with a demonstrated track record of achieving results and optimizing team performance
Launch experience required
Experience with gene therapy and/or rare disease preferred
Ability to travel ~25%
Posted
3 months ago
Pharma.fan is a pharma, biotech and med device jobs portal. List your company jobs for free.