Medical Director, US Medical Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement the Medical Affairs strategy and US Plan of Action for aficamten.

• Act as a medical and scientific authority on hypertrophic cardiomyopathy.

• Educate healthcare professionals regarding aficamten’s clinical profile and its role in HCM therapy.

• Provide medical leadership throughout development, launch preparation, and lifecycle management.

• Carry out medical launch initiatives.

• Offer medical insights for brand strategy, evidence generation, market access, and lifecycle management plans.

• Deliver medical expertise for REMS activities.

• Collaborate with Clinical Development, Commercial, Regulatory, Safety, HEOR, Market Access, and Legal/Compliance teams.

• Strategize for scientific congresses, advisory boards, field-force training, medical information responses, and related strategic projects.

• Partner with regional, global, and US Field Medical Affairs colleagues.

• Support medical education initiatives, grant processes, sponsorship reviews, and evaluate initiative metrics.

• Oversee medical programs, vendors, timelines, budgets, contracts, and performance measures.

• Address inquiries from healthcare professionals by providing clinical and scientific support.

• Review medical and promotional scientific materials through MLR processes.

• Contribute to integrated evidence planning, identifying evidence gaps, real-world evidence, and investigator-sponsored research.

• Establish priorities for field medical science, training plans, and stakeholder engagement strategies.

• Analyze insights from field medical interactions to guide medical, evidence-generation, and educational strategies.

• Aid in the development of field materials and field medical education initiatives.

• Create and maintain a network of US hypertrophic cardiomyopathy key opinion leaders.

• Engage with external hypertrophic cardiomyopathy experts for scientific discussions.

⛳️ Requirements

• An MD/DO or PharmD is required.

• A minimum of 3-5 years of experience in Medical Affairs is required.

• Prior experience as a Medical Director in the pharmaceutical industry and Medical Affairs is essential.

• Cardiovascular training and clinical experience are strongly preferred.

• Understanding of Medical Affairs strategy, including evidence generation, scientific communications, and external engagement is necessary.

• Experience with product approvals, launches, and peri-launch activities is highly desirable.

• A background in academic medicine and clinical research is important.

• Familiarity with biostatistics and epidemiology is expected.

• Experience in managing vendors, budgets, and strategic timelines is necessary.

• Proven ability to develop medical plans and align medical objectives with broader product and organizational strategies.

• Knowledge of OPDP, PhRMA code, and key pharmaceutical industry regulations is important.

• Capability to evaluate and interpret clinical trial data, peer-reviewed literature, treatment guidelines, and real-world evidence is required.

• Ability to work independently as well as part of an integrated, interdisciplinary team is essential.

• Skill in translating complex scientific information into clear, accurate, and actionable medical guidance is necessary.

• Strong project management abilities, including managing multiple priorities, budgets, vendors, timelines, and deliverables.

• Working knowledge of congress strategy, advisory boards, medical education, and scientific communications is crucial.

• Excellent oral, written, presentation, and executive communication skills are required.

• High levels of scientific integrity, sound medical judgment, professionalism, and commitment to patient benefit are essential.

• Proficiency in Microsoft Office is necessary.

• Willingness to travel approximately 30% of the time is required.

🏝️ Benefits

• Equity in the form of stock options and/or restricted stock units.

• Comprehensive health, dental, vision, life, and disability insurance coverage.

• 401k retirement benefits with employer matching.

• Learning stipends.

• Wellness stipends.

• Paid time off.