Position Overview:

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%