The US Head of Medical Affairs, reporting to the SVP Head of Global Medical Affairs, will be a member of the Medical Affairs Leadership Team (MALT). She/he will be responsible for providing strategic and medical/scientific leadership to the US launch of the apitegromab and pipeline programs. The successful candidate will lead the US medical team in the development of the US medical strategy in alignment with the program strategy. This individual will be accountable for the strategic oversight of all US Medical Affairs activities, will serve as the primary point of contact for all program specific US Medical Affairs activities, and will liaise with cross functional counterparts in Commercial, Clinical Development, Regulatory, Safety, Program Leadership, Access, and other functional areas. The successful candidate will provide effective leadership, strategic insight and guidance, and will own the development and execution of key US launch medical initiatives in close collaboration with internal and external stakeholders.

Position Responsibilities:

• • Provide strategic and medical/scientific leadership to the apitegromab and pipeline programs.
  • Lead the US Medical Affairs team in the development and execution of the US Medical Affairs strategy in alignment with the apitegromab global program strategy.
  • Accountable for the strategic oversight and execution of all US Medical Affairs activities
  • Represent US Medical Affairs at Program, Launch, and other cross functional team meetings
  • Collaborate with Global Medical, Clinical Development, Regulatory, Commercial, Operations and other functions as needed to create the US medical strategy, to ensure strong cross functional alignment, and to execute on the US medical strategy and tactics of apitegromab and pipeline products
  • Partner with cross-functional stakeholders to define and prioritize US evidence gaps, develop and implement US evidence generation strategy (e.g. natural history studies, phase 4 studies, disease registries, post-hoc analyses etc.) to address strategic gaps and inform evidence-based clinical and payer decision making
  • Provide medical oversight of prospective and retrospective observational studies, comparative effectiveness research, chart reviews, registry studies, and other evidence generation projects
  • Partner with Global Medical Communications to formulate the US data dissemination/publication strategy, and its timely dissemination in the field and at key US meetings
  • Work closely with internal teams to define the key US stakeholder engagement strategy and tactics.
  • Drive excellence in scientific engagement with key US external stakeholders to gain a deep understanding of customer needs, and to foster a positive experience.
  • Oversee the creation and implementation of internal and external US training and education activities
  • Manage the US medical affairs budget
  • Other duties and responsibilities as required.

Candidate Requirements:

• • PharmD, PhD, MD or equivalent scientific degree. MBA is a plus
  • 7+ years of demonstrated high-level professional knowledge and skills in the areas of Medical Affairs and R&D in the pharmaceutical or biotech industry
  • 3+ years in leading teams in R&D (Medical Affairs, Medical Operations, and/or Clinical Development)
  • Medical launch experience
  • Demonstrate experience in working with rare or genetic diseases in a fast clinical and product development timeline
  • Knowledge of the biopharmaceutical industry and evidence generation with an understanding of key regulatory bodies
  • Ability to operate in a matrix team-oriented structure
  • High degree of professionalism, maturity, and confidentiality
  • Strong written and verbal communication skills as well as strong leadership and interpersonal skills
  • Demonstrated reputation as a well-respected, dynamic team leader, player and coach
  • Capable of managing shifting priorities in a rapidly changing and environment
  • Ability to deliver on company global program goals and objectives as they pertain to Medical Affairs
  • Ability to affect positive organizational change at the company and team levels
  • Travel will be required (approximately 25%)