Senior Director, Clinical Development (Neuromuscular)

Senior Director, Clinical Development, Neuromuscular

Soufflé Therapeutics

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. Its team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-built lab and office space in Watertown. Come and join us in our quest!

Position Summary

The Senior Director, Clinical Development, Neuromuscular will develop the clinical strategy and execution of our neuromuscular disease development program. Working closely with internal and external stakeholders, this individual will drive clinical development plans, provide medical leadership for one or more clinical studies, and contribute to study design, protocol development, data interpretation, regulatory submissions, publications, and presentations. As a key member of the development team, this individual will guide cross-functional activities to achieve program objectives while ensuring compliance with ICH-GCP and applicable regulatory requirements. This is an individual-contributor role with no direct reports at this time.

Key Responsibilities

Clinical Strategy & Leadership

• Lead creation and execution of medical plans across the US, Europe, and other potential jurisdictions.
• Ensure alignment with overall portfolio objectives and corporate strategy.
• Provide medical leadership and scientific guidance to cross-functional program teams through all phases of clinical development.
• Evaluate and integrate emerging scientific, clinical, and competitive insights into development strategies.

Clinical Trial Design & Execution

• Provide scientific/medical input and contribute to the development of clinical content including protocols, amendments, investigator brochures, informed consent forms, clinical study reports, statistical analysis plans, and study manuals.
• Responsible for developing and implementing study protocols in conjunction with the clinical development team.
• Serve as Medical Monitor, or provide oversight and guidance to designated Medical Monitors, across clinical programs; provide medical oversight, review safety data, and ensure adherence to protocol and regulatory standards.
• Partner with clinical operations to support site selection, investigator training, and issue resolution during study conduct.

Safety & Compliance

• Oversee the assessment and interpretation of safety data, including adverse events, safety signals, and risk mitigation strategies.
• Work closely with pharmacovigilance to ensure timely evaluation and reporting of safety information.
• Ensure clinical programs follow ICH-GCP, ethical standards, and regional/global regulatory requirements.

Regulatory & Scientific Communication

• Contribute to the preparation and review of regulatory submissions including INDs, CTAs, briefing documents, and NDAs/BLAs.
• Represent the clinical program in interactions with health authorities such as FDA, EMA, and other global agencies.
• Develop and review key clinical documents including protocols, investigator brochures (IBs), clinical study reports (CSRs), and publications.

Cross-Functional Collaboration

• Partner cross-functionally with R&D, clinical operations, biostatistics, regulatory affairs, safety, patient affairs, medical affairs, and commercial teams.
• Provide medical and scientific expertise for internal decision-making and external communication.
• Support advisory boards, KOL engagement, and scientific congress activities.

External Engagement

• Build and maintain relationships with investigators, key opinion leaders, and external experts.
• Stay current on scientific advances, competitive intelligence, and therapeutic area trends to inform program direction.

Qualifications

• M.D. or D.O. required; significant neuromuscular disease clinical development experience strongly preferred (e.g., neuromuscular neurology, physiatry, or related specialty training).
• Minimum of 10–15 years of relevant experience with a demonstrated track record of success in clinical research and drug development within academia, biotechnology, and/or the pharmaceutical industry.
• Demonstrated experience designing and executing clinical programs across multiple phases and geographic regions.
• Strong knowledge of GCP, ICH guidelines, global regulatory requirements, and the drug development process.
• Proven medical and scientific leadership of cross-functional teams, with experience engaging regulatory agencies, investigators, KOLs, and external partners.
• Excellent analytical, strategic, and communication skills.
• Experience authoring and reviewing key clinical and regulatory documents and contributing to global regulatory submissions and health authority interactions.

Education

• M.D. or D.O. required.

Compensation

At Soufflé Therapeutics, we are intentional about building an equitable culture. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.