Director, EU Medical Affairs (EDG-2025050)

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

The Director, EU Medical Affairs is responsible for Medical Affairs activities in the EU, including operations, the development and management of medical communication and publication activities, supporting Medical Affairs activities at our scientific congresses, including HCP engagement, and supporting the annual planning and budgeting processes for Medical Affairs. The Director, EU Medical Affairs, reports into the head of Medical Affairs.

Essential Job Duties and Functions:

• Develop and support conference planning activities, publication planning activities and annual planning and budgeting for Medical Affairs, with an emphasis on EU based activities and support.
• Provide project and operations support across Medical Affairs workstreams, including organization and development of shared resources, policies and processes.
• Assess Medical Affairs capabilities, systems, and processes to identify gaps and recommend improvements.
• Support medical communication materials and publication development as needed.
• Working with key stakeholders within Medical Affairs, support the planning and execution of Scientific Advisory Boards, ensuring the proper development of content and key strategic questions for the advisor.
• In collaboration with key stakeholders within Medical Affairs and other cross-functional partners, support all medical and scientific activities at key medical congresses, including the development of medical and/or therapeutic area booth materials, abstract development, poster development and symposium content development.
• Develop and track metrics for medical affairs activities.
• Assist in the management of all financial and contractual aspects of assigned projects, including external vendors.
• Assist in the review of assigned medical content for medical accuracy and fair balance.
• Develop and expand scientific proficiency in assigned therapeutic area(s).
• Participate in and lead department initiatives/projects.

IME/Grants/External Sponsored Research (ESRs) Management:

• Serve as the key point of contact for all IME/Grants/ESR-related requests with internal and external stakeholders.
• Partner with cross functional teams to develop and implement an IME/Grants/ESR request process, including proposal review, approval, funding, and execution.
• Monitor ongoing requests, ensuring milestone tracking, study reporting, and data dissemination.
• Ensure that requests align with scientific and strategic objectives while maintaining compliance with regulatory and legal requirements.
• Build and maintain relationships with external medical and scientific communities, including medical societies, KOLs, and academic researchers.
• Ensure timely and transparent communication with investigators, maintaining strong external partnerships.

EU Clinical Site Liaison:

• Engage and establish relationships with Key Opinion Leaders and other HCPs in the EU in support of all Medical Affairs activities within the region as needed.
• Work cross-functionally with colleagues within the clinical team in support of clinical trial sites to ensure all medical scientific needs and goals are addressed as needed.

Required Education, Experience and Skills:

• Ability to create and manage the creation of high-quality documents that effectively and clearly convey scientific data, properly identify/target the audience for each document, and communicate clearly and concisely.
• Demonstrated ability to apply strategic thinking and scientific acumen to projects and plans.
• Demonstrated experience interacting with and collaborating with external experts; ability to effectively interact with internal and external stakeholders.
• Experience managing external agencies and supporting the RFP process to identify agencies and systems.
• Excellent oral communication and interpersonal skills and written communication skills.
• Understand clinical trial research, the drug development process, and have experience with reviewing clinical trial data.
• Prior medical content development or management of medical content experience preferred.
• Proficiency with computer programs such as MS Word, Excel, and PowerPoint, as well as databases such as PubMed.
• Travel will vary, plan on 10-20%.