Senior Director, Medical Affairs

Edgewise Therapeutics

8d•$225,000 - $285,000

About The Position

The Senior Director, Medical Affairs is an experienced, highly collaborative, and action-oriented leader responsible for developing and executing medical affairs strategy within the cardiovascular therapeutic area. This individual will provide strategic medical leadership across external scientific engagement, evidence generation, scientific communications, medical education, and cross-functional launch readiness activities. The role requires deep scientific expertise, strong judgment, and the ability to translate complex clinical and scientific information into clear, compliant, and impactful medical strategies. As a key member of the Cardiovascular Strategy Team, the Senior Director will partner closely with Field Medical Affairs, Scientific Communications, Clinical Development, Clinical Operations, Regulatory, Commercialization, Market Access, and other cross-functional stakeholders to support the successful advancement of Edgewise’s cardiovascular pipeline.

Requirements

Master’s degree or advanced degree in a health-related field required; MD, PhD, DNP, or PharmD preferred.
12+ years of relevant experience, including significant experience in Medical Affairs, medical strategy, clinical development, scientific communications, or related roles within the biotechnology or pharmaceutical industry.
Advanced scientific degree with 7+ years of cardiovascular experience strongly preferred.
Demonstrated cardiovascular expertise required; experience in cardiomyopathy, heart failure, rare cardiovascular disease, or specialty cardiovascular therapeutics preferred.
Strong knowledge of Medical Affairs strategy, including medical planning, launch readiness, external engagement, scientific communications, and field medical enablement.
Strong understanding of the drug development process, clinical trial design and execution, and medical/legal/regulatory review processes.
In-depth knowledge of the U.S. healthcare environment, including regulatory requirements, payer considerations, treatment pathways, and healthcare provider networks.
Proven ability to develop, review, and approve high-quality scientific and medical content in accordance with legal, regulatory, compliance, company policy, and Good Publication Practice requirements.
Demonstrated ability to communicate complex scientific and medical information clearly and effectively to a range of internal and external audiences.
Excellent communication, presentation, project management, and stakeholder management skills, with the ability to build productive relationships across functions and with external experts.
Strong proficiency with commonly used office software, including Microsoft Word, Excel, and PowerPoint.

Nice To Haves

Track record of contributing to successful product launches or late-stage launch preparation within the previous 3-5 years preferred.
Experience managing medical communications agencies, vendors, and/or freelance scientific partners preferred.

Responsibilities

Develop and lead cardiovascular Medical Affairs strategy and tactical planning, including scientific exchange, advisory boards, field medical communications, annual planning, and medical launch readiness activities.
Provide senior medical leadership in the development and execution of integrated evidence plans, including data generation, data communication, investigator-initiated studies, and real-world evidence activities in collaboration with HEOR and cross-functional partners.
Build and maintain strategic relationships with clinical investigators, key opinion leaders, professional societies, collaborative groups, advocacy organizations, and other external healthcare stakeholders.
Maintain a high level of scientific expertise in cardiovascular disease areas of interest, including the competitive landscape, clinical practice trends, trial methodology, treatment guidelines, and Edgewise’s cardiovascular pipeline.
Partner with Field Medical Affairs leadership to shape and execute disease- and indication-specific regional strategies, ensuring appropriate prioritization, resource allocation, and alignment with broader medical objectives.
Provide strategic medical input into publications and scientific communications, including congress abstracts, posters, presentations, manuscripts, digital materials, and related scientific content.
Lead or contribute to the development of scientifically rigorous, balanced, and compliant educational materials, advisory board content, medical information response documents, and other medical resources.
Support scientific symposia, medical congress activities, and external education initiatives in accordance with applicable legal, regulatory, and compliance requirements.
Lead or participate in Medical Information processes, ensuring timely, accurate, balanced, and compliant responses to medical inquiries.
Develop tailored scientific education plans for healthcare professionals and advanced practice providers through appropriate enduring, live, and field-enabled programs.
Serve as a compliant scientific and medical subject matter resource for internal stakeholders, including Commercialization, Market Access, Patient Advocacy, Clinical Development, Regulatory, and other cross-functional teams.
Provide medical affairs input into the design, conduct, interpretation, and communication of clinical trials, as appropriate.
Manage the Medical Affairs budget for assigned activities, ensuring appropriate resource allocation, operational discipline, and alignment with company priorities.
Assess the impact of Medical Affairs strategies using relevant performance metrics and insights, and adjust plans to enhance effectiveness and alignment with company objectives.
Read, understand, and comply with all workplace health and safety policies, safe work practices, and company policies and procedures.
Perform other duties as assigned by supervisor.