Vice President, Regulatory Strategy and CMC

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

About Stoke:

Stoke Therapeutics(Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Vice President, Regulatory Strategy & CMC is responsible for leading teams to develop and execute global regulatory and Chemistry, Manufacturing & Controls (CMC) strategies across the company’s product portfolio. This leader provides strategic direction for regulatory interactions, product development, manufacturing, quality, and commercialization activities to support clinical development, regulatory approvals, and lifecycle management.

The VP will lead cross-functional collaboration across Regulatory Affairs, Technical Operations, CMC , Quality, Clinical Development, Supply Chain, and external partners to ensure successful advancement of programs from early development through commercialization. The role serves as the primary executive advisor on regulatory and CMC risks, opportunities, and policy considerations impacting corporate strategy.

Key Responsibilities

Regulatory Strategy Leadership

• Provide oversight and guidance into development and implementation of integrated global regulatory strategies for Stoke programs.
• Lead and manage teams responsible for INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions.
• Serve as the executive lead for interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies.
• Provide strategic regulatory guidance to executive leadership and program teams regarding development pathways, agency expectations, accelerated programs, 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.

CMC Strategy & Technical Operations

• Provide oversight and guidance into enterprise-wide CMC strategies for drug substance, drug product, analytical development, process development, manufacturing, supply, and combination drug-device development.
• Ensure phase-appropriate CMC development plans are aligned with regulatory expectations and business objectives.
• Lead and manage teams responsible for CMC readiness activities supporting clinical studies, registration, launch, and lifecycle management.
• Partner with Quality and Technical Operations to ensure compliance with cGMP, ICH, FDA, EMA, and global regulatory requirements.
• Provide strategic regulatory guidance on long-range manufacturing and supply strategies to support global commercial expansion.

Organizational Leadership

• Build, mentor, and lead high-performing Regulatory Strategy and CMC teams.
• Establish department goals, governance processes, resource planning, and budget management.
• Foster a collaborative, science-driven, and compliance-focused culture.
• Influence company strategy through participation on executive leadership committees and governance boards.
• Manage external consultants, CROs, CDMOs, and strategic partnerships supporting regulatory and manufacturing activities.

Commercialization & Lifecycle Management

• Support launch readiness activities and commercial regulatory strategies.
• Oversee post-approval changes, global lifecycle management activities, and market expansion initiatives.
• Ensure regulatory compliance throughout the product lifecycle while enabling operational flexibility and business growth.
• Identify regulatory and manufacturing risks and develop proactive mitigation strategies.

Required Skills & Experience:

• Ph.D., Pharm.D., M.S., 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.

Critical Competencies

• Executive presence and ELT-level communication
• Risk assessment and decision-making
• Cross-functional influence and collaboration
• Change management and organizational leadership
• Negotiation and stakeholder management
• Financial and operational planning

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position, currently based in Bedford and will later be based in Waltham.

Travel:

This position will require approximately 10% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $345,000 - $395,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.