Global VP, Regulatory Strategy & CMC Leadership

Stoke Therapeutics; Bedford (MA); Híbrido; USD 345.000 - 395.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity-based compensation

Medical, dental & vision

401(k) with match

Paid parental leave

Unlimited vacation

Descripción de la vacante

Stoke Therapeutics is seeking a Vice President, Regulatory Strategy & CMC to lead global regulatory and CMC strategies across the portfolio. This leader guides interactions with FDA and other major agencies to support clinical development, regulatory approvals, and lifecycle management.

The VP will direct cross-functional teams in Regulatory, CMC, Quality, Clinical Development, and Supply Chain, mentoring leaders and shaping post-approval activities.

Formación

• Ph.D., Pharm.D., MS, or advanced scientific degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, or related discipline preferred.
• 12+ years of progressive experience in biotechnology, pharmaceutical, or cell and gene therapy industries, with at least 6 years in a leadership capacity.
• Deep expertise in global Regulatory Affairs and CMC development.
• Demonstrated success leading major regulatory submissions and health authority interactions.
• Experience advancing products from early development through commercialization.
• Significant experience managing multiple development programs.
• Proven executive leadership experience building and managing multidisciplinary teams.

Responsabilidades

• Develop and execute global regulatory and CMC strategies across Stoke's portfolio.
• Lead INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions.
• Serve as executive lead for interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other agencies.
• Provide strategic regulatory guidance to executive leadership and program teams on development pathways and risk mitigation.
• Monitor evolving regulatory requirements and assess impacts on development and commercial programs.
• Support corporate business development, licensing, due diligence, and portfolio evaluation activities.
• Lead cross-functional collaboration across Regulatory Affairs, Technical Operations, CMC, Quality, Clinical Development, Supply Chain, and external partners.

Conocimientos

Executive leadership

Regulatory strategy

CMC development

Global regulatory affairs

Health authority interactions

Project management

Educación

Ph.D./Pharm.D./MS in Pharmaceutical Sciences or related

Herramientas

INDs/CTAs/NDAs management

Descripción del empleo

Stoke Therapeutics is seeking a Vice President, Regulatory Strategy & CMC to lead global regulatory and CMC strategies across the portfolio. This leader guides interactions with FDA and other major agencies to support clinical development, regulatory approvals, and lifecycle management.

The VP will direct cross-functional teams in Regulatory, CMC, Quality, Clinical Development, and Supply Chain, mentoring leaders and shaping post-approval activities.