Encoded Therapeutics Inc.

Medical Director

• Define and implement the strategic plan for Encoded’s ETX301 clinical development program for pain
• Collaborate with Scientific Communications, Clinical Development, the Medical Office, and Patient Advocacy
• Build relationships with Key Opinion Leaders to support clinical trial design and enrollment
• Partner with Commercial, Strategy, Pre-clinical/Translational, Clinical Development/Operations, and Regulatory teams
• Provide scientific and competitive insights from conferences and medical engagements
• Develop and manage Investigator Sponsored Studies, observational studies, and other research supporting endpoint development or validation
• Develop disease-state, mechanism-of-action, target-product-profile, and clinical-trial communication plans
• Prepare or review scientific communication materials
• Define and manage long-range budget forecasts
• Identify, recruit, and manage vendors
• Develop methods and procedures for scientific presentations
• Represent Encoded and present data at advisory boards, investigator meetings, congresses, and other forums

Director, Medical Affairs

• Own and manage assigned clinical, regulatory, and preclinical deliverables supporting Encoded’s programs.
• Research, author, edit, and manage clinical and regulatory documents, including protocols, Investigator Brochures, clinical study reports, INDs/CTDs, BLAs, amendments, plans, safety updates, narratives, summaries, and briefing books.
• Partner with cross-functional teams to analyze and interpret clinical data and translate findings into scientifically accurate content, conclusions, and key messaging.
• Perform literature and scientific database searches to support analyses and background summaries.
• Contribute medical writing expertise to document strategy, organization, messaging, consistency, efficiency, and clarity.
• Develop and implement medical and scientific writing infrastructure, including templates, processes, standards, style guides, workflows, operating procedures, QC practices, publishing readiness, and editing standards.
• Develop timelines, manage multiple writing projects, communicate risks or resource needs, and coordinate workload with the Head of Medical Writing.
• Collaborate with authors, vendors, service providers, and clinical investigators to support document development and track milestones.
• Coordinate review cycles, adjudicate comments, and produce high-quality, scientifically accurate, compliant final deliverables.
• Ensure documents adhere to company standards, style guides, and ICH, FDA, EMA, and other regulatory requirements.
• Review Statistical Analysis Plans and Tables, Figures, and Listings and provide feedback on data presentation.
• Maintain scientific, medical, regulatory, and technical knowledge relevant to the pipeline, gene therapy platform, clinical studies, and disease areas.

Associate Director, Medical Writing

Therapist

• Drive day-to-day execution of regulatory activities for ETX-301 and supporting work on ETX-101 and other gene therapy programs
• Contribute to clinical regulatory strategy for adult neuropathic pain and CNS-targeted gene therapy
• Prepare, review, and coordinate regulatory submissions, including IND/IMPD amendments, briefing packages, and responses to health authority questions
• Support interactions with US and ex-US health authorities, including FDA, EMA, and relevant national agencies
• Partner with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams
• Monitor, interpret, and communicate global regulatory guidelines and expectations in gene therapy and neurology/pain
• Contribute to regulatory risk identification, mitigation planning, and issue resolution
• Ensure consistent messaging and documentation across regulatory submissions and internal stakeholders
• Maintain accurate tracking, documentation, and archival of regulatory submissions and correspondence
• Report into the regulatory leadership team

Director, Medical Affairs

Associate Director, Medical Writing

Manager, Regulatory Affairs – Gene Therapy