Neuromuscular Clinical Development Director

Soufflé Therapeutics; Watertown (MA); On-site; USD 250,000 - 320,000; Full time

Job summary

Soufflé Therapeutics is seeking a Senior Director, Clinical Development, Neuromuscular to lead the clinical strategy and execution for our neuromuscular program. This role includes shaping study design, medical leadership, regulatory submissions, and cross-functional collaboration across the US and Europe.

You will drive development plans, monitor safety, and ensure adherence to ICH-GCP while engaging with regulators, investigators and external partners.

Qualifications

• MD/DO required to practice medicine and lead clinical programs.
• Neuromuscular disease clinical development experience is highly preferred.
• Demonstrated ability to design and execute multi-phase, multi-region clinical programs.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.

Responsibilities

• Lead creation and execution of medical plans across the US, Europe, and other jurisdictions.
• Develop and oversee study protocols, IBs, CSRs, and regulatory submissions.
• Serve as Medical Monitor and provide oversight of safety data and regulatory adherence.
• Partner with R&D, regulatory affairs, safety, and operations to enable program success.

Skills

Analytical skills

Strategic thinking

Communication skills

Medical leadership

Cross-functional collaboration

Regulatory interactions

Education

MD/DO

Neuromuscular clinical development

Job description

Soufflé Therapeutics is seeking a Senior Director, Clinical Development, Neuromuscular to lead the clinical strategy and execution for our neuromuscular program. This role includes shaping study design, medical leadership, regulatory submissions, and cross-functional collaboration across the US and Europe.

You will drive development plans, monitor safety, and ensure adherence to ICH-GCP while engaging with regulators, investigators and external partners.