Senior Director, US Medical Affairs

Overview

Encoded Therapeutics is a biotechnology company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases. For more information, please visit

Reporting to the VP Clinical/Medical Affairs, the Senior Director of US Medical Affairs is a high-impact leadership role responsible for building and executing the US Medical Affairs strategy as Encoded prepares for BLA and commercial launch.

This individual will provide critical input across the product lifecycle and must be a creative thinker capable of producing and executing rapid, high-quality strategic plans. Collaborating closely with cross-functional teams, this is a highly visible internal and externally-facing position to ensure appropriate education, insights, and launch excellence.

US Launch Strategy & Execution

• Drive the development and execution of the integrated US Medical Affairs strategy, ensuring alignment between clinical development and commercial launch requirements.
• Design US Field Medical strategy and planning, defining engagement models and territory mapping across US treatment centers, as well as performing field-based engagement and research, as needed.
• Remain at the forefront of gene therapy science and the competitive landscape to inform internal strategy and external positioning. Provide clinical and competitive insights to shape launch needs and market entry.

External Engagement & Execution

• Cultivate and maintain deep professional relationships with US Key Opinion Leaders (KOLs), healthcare professionals, and industry experts to exchange scientific knowledge, identify clinical trial opportunities, and understand commercial needs.
• Represent Encoded at major medical congresses, advisory boards, and investigator meetings, presenting complex data with clarity

Cross-Functional Collaboration

• Collaborate closely with Scientific Communications to ensure medical messages, publication plans, and educational materials are scientifically rigorous and strategically aligned with US regulatory standards.
• Work in lockstep with Patient Advocacy to ensure the patient voice is integrated into clinical trial design and commercial planning.
• Support development of a comprehensive US HEOR and outcomes research plan to support market access, PBM negotiations, and reimbursement.
• Partner with Clinical and HEOR teams to design evidence generation activities, including Investigator Sponsored Studies (ISS) and observational research to support regulatory approval and endpoint validation.
• Partner with Commercial, Regulatory, and Clinical to ensure a seamless transition from development to market.
• Lead US-specific initiatives, including payer/HTA research and value messaging, launch roadmaps, and center of excellence and patient journey mapping to ensure development of approaches that address the unique opportunities and challenges of gene therapy.
• Develop and manage long-range budget forecasts and oversee vendors to ensure timely delivery of US medical materials.

• Educational Background: MD, PhD, Pharm
  
  D or MD/PhD.
• Experience:
  
  A minimum of 10–12 years in Medical Affairs, including at least 3–5 years specifically supporting Phase 1–3 clinical development and a proven track record in US pre-commercial planning and building US Medical Affairs functions.
• Strong familiarity with US payer and/or PBM requirements for value demonstration and reimbursement.
• Prior expertise in gene therapy (ATMPs), neuroscience (e.g., epilepsy/CNS), and/or pediatric rare diseases.
• Deep understanding of FDA guidelines, OIG compliance, and US-specific requirements for scientific exchange.
• Strategic thinker while maintaining tactical execution excellence; a self-starter who can produce complex plans and adapt rapidly. Exemplary organizational skills.
• Exceptional ability to build collaborative partnerships in a matrixed, small-team environment, and to forge strong external relationships with external subject matter experts.
• Strong skills in interpreting scientific/clinical research and translating it into actionable medical strategy to support treatment access…