Vice President, Head of Clinical R&D

Role Summary

Vice President, Head of Clinical R&D (HoC) – Solid Biosciences. Lead strategic direction and technical leadership for clinical R&D and clinical scientist groups, overseeing Phase I–IV programs, clinical development, pharmacovigilance, trial design and execution, data management, and regulatory alignment. Collaborate with CMO and executive team to guide translational development, IND/lead candidate planning, and potential partnerships. Based in Hood Park, Charlestown, MA or remote on the East Coast.

Responsibilities

• Provide oversight and leadership of Clinical R&D, clinical science, medical monitoring, and pharmacovigilance.
• Collaborate with Research to design preclinical programs supporting clinical translation (CDP, TPP, IND/CTA clearance).
• Ensure patient-centricity from conception through trial conduct to commercial launch; represent patient and physician perspectives in decisions.
• Manage multiple programs across geographies.
• Contribute to development of key marketing materials.
• Identify new therapeutic opportunities aligned with company goals.
• Establish relationships with principal investigators and KOLs to understand clinician needs.
• Communicate clinical and regulatory programs to executive leadership, regulatory agencies, investors, and board.
• Support collaborations with other pharma partners for studies and regulatory activities.
• Attract, motivate, and lead a high-performing clinical development and regulatory team.
• Maintain awareness of competitors and relevant literature; attend scientific meetings as needed.
• Perform ad hoc duties and projects; maintain and adapt R&D structure and cross-functional relationships; foster mentorship and professional growth.

Qualifications

• Board Certified MD with medical research and drug development experience.
• MD with regenerative medicine (e.g., AAV) preferred.
• MD with experience in neuromuscular and/or cardiovascular rare diseases preferred.
• Proven leader of high-potential, high-performing teams.
• Experience in global clinical development leadership across all phases; track record of filing and approval in US and globally.
• Experience interfacing with FDA/EMA; knowledge of GCP and regulatory guidance relevant to the company.
• Excellent interpersonal and communication skills; ability to build relationships with executive team and board.
• Ability to foster a science- and ethics-centered company culture.

Skills

• Clinical development strategy and leadership
• Regulatory affairs and compliance (FDA/EMA, GCP)
• Program management across multiple geographies
• Stakeholder engagement with investigators, KOLs, patients, and partners
• Data analysis and pharmacovigilance oversight
• Team building, mentorship, and cross-functional collaboration

Education

• MD (Board Certified) required; regenerative medicine experience preferred.

Additional Requirements

• Travel: expected 20% travel; may require significant ad hoc travel.