SVP, Head of Clinical Development

Company Overview:

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

Role Summary:

The SVP, Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will provide strategic leadership for the clinical and medical aspects and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. The role is responsible for overseeing trials in clinical development and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs. The Head of Development will act as a cross functional advisor and will work closely with the internal and/or external Clinical Development, Pharmacovigilance, biostatistics group(s), R&D, Regulatory, and the Commercial Development teams to execute clinical trial strategy and design.

This role is based in Waltham, MA without the possibility of being remote. 

Primary Responsibilities Include:

• Design and oversee execution of multi-layered clinical development strategies
• Maintain compliance with regulatory guidelines, that identify opportunities for breakthrough therapy designation and accelerated approval while identifying subsequent opportunities for label expansion
• Inform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities
• Manage drug safety and pharmacovigilance activities for ongoing trial(s)
• Prepare clinical portions of IND submissions and BLAs, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios
• Rapidly integrate new insights from on-going in-house or external clinical trials, translational science into development plans and clinical trial activities
• Create compelling data presentations for external disclosures
• Collaborate with research leadership and drug discovery teams to shape the company’s drug discovery portfolio
• Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings
• Establish and maintain relationships with external companies (such as CROs), investigators and opinion leaders to optimize performance on clinical trial activities
• Prepare manuscripts for technical journals and make presentations at scientific meetings
• Work collaboratively with Research to provide input into design of preclinical studies to support drug products entering or in the clinic and by helping initiate IND submissions
• Provide input to evaluate products for in licensing/out licensing
• Participate in business development processes as needed
• Provide clinical portion of regulatory documents such as Investigator Brochure updates, and Drug Safety Update Reports
• Manage and be responsible for pharmacovigilance for clinical projects including review and reporting with support from the pharmacovigilance team
• Provide leadership and guidance for the clinical development team to ensure efficient execution to meet deliverables and timelines
• Oversee medical monitor activities for all phases of studies through direct execution of activities or supervision of a medical monitor

 Education and Skills Requirements:

• PhD, PharmD, or MD required
• 20+ years of progressive relevant experience within the biopharmaceutical/biotech industry in translational medicine/biology, clinical phar