Senior Medical Director, Global Medical Affairs

The Senior Medical Director, reporting to the VP, Head of Medical Affairs, will be a member of the Medical Affairs Leadership Team (MALT), responsible for providing strategic and medical/scientific leadership for the apitegromab program. The successful candidate will lead the medical subteam to develop the Global Medical strategy in alignment with the program strategy. This individual will be accountable for the strategic oversight of all Medical Affairs activities, globally. The successful candidate will serve as the primary point of contact for all program specific Medical Affairs activities and will liaise with counterparts in Clinical Development, Regulatory, Safety, Program Leadership, Global Marketing, Global Access, and other functional areas. The successful candidate will provide effective leadership, strategic insight, and ensure execution of key initiatives while collaborating cross functionally to ensure successful preparation and launch of the apitegromab program.

The work you'll be doing

• • Provide strategic and medical/scientific leadership to the apitegromab therapeutic program by leading the Medical Affairs subteam to develop and execution of the Global Medical Affairs strategy in alignment with the apitegromab program strategy
  • Accountable for strategic oversight of all Global Medical Affairs activities
  • Represent Medical Affairs at Program Team and other cross functional meetings as needed (eg, Global Brand team)
  • Collaborate with Clinical Development, Regulatory, Commercial, Clinical Development Operations and other functions as needed to establish portfolio strategy, ensuring appropriate alignment, prioritization, and execution of apitegromab strategy and plans
  • Partner with cross-functional stakeholders to define and prioritize evidence gaps, develop and implement 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 Medical Communications to ensure timely dissemination of scientific data (publications and congress presentations)
  • Work closely with Global Marketing to define key stakeholder engagement strategy and oversee engagement activities of global KOLs
  • Partner with Medical Communications and Field Medical to develop and deliver high quality scientific and skill-based training to Medical Affairs team, globally
  • Other duties and responsibilities as required

The expertise we're looking for

• • Must have PharmD, PhD, MD or equivalent
  • 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)
  • 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
  • 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%

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.