Vice President, Clinical Operations

Stoke Therapeutics • Bedford, MA

32d • $311,000 - $374,000 • Hybrid

About The Position

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 approach, the company 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 entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights
STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Stoke’s initial focus is on 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 the Company’s proprietary approach.
The Vice President (VP) of Clinical Operations is a strategic executive responsible for providing leadership, oversight, and direction for all global clinical trial operations. Reporting to the Senior Vice President (SVP), Clinical Development Operations, the VP will drive the successful, timely, and cost-effective execution of the clinical trial portfolio. This role leads a high-performing Clinical Operations organization and partners closely with other functions to ensure studies are conducted in accordance with Good Clinical Practice (GCP), regulatory requirements, and the company’s strategic goals. The VP will also serve as the deputy for the SVP, Clinical Development Operations, providing executive-level support, representation, and continuity of leadership as needed.

Requirements

• Bachelor’s or advanced degree in Life Sciences or a related field, with approximately 20 years of progressive experience in Clinical Operations, including at least 3 years leading a Clinical Operations department.
• Demonstrated success in delivering complex global clinical programs across multiple therapeutic areas and phases.
• Experience building or scaling the clinical operations function from early-stage to late-stage programs in a biotech setting.
• Familiarity with global trial execution across US, EU, Japan, emerging markets and with multi-region regulatory submission strategies.
• Experience implementing clinical operations systems (CTMS), process improvements and change management.
• Direct experience contributing to regulatory submissions and marketing authorization applications (e.g., NDA, BLA, MAA, or equivalent).
• Experience with regulatory inspections (FDA, EMA, PMDA, or other authorities), including preparation and post-inspection follow-up.
• Deep understanding of ICH GCP, FDA, EMA, and global regulatory requirements.
• Strong vendor/CRO oversight, budget management, and strategic execution expertise.
• Exceptional communication, leadership presence, and strategic decision-making skills.
• Ability to thrive in a fast-paced, dynamic, and highly collaborative environment.

Nice To Haves

• Prior experience in rare disease, pediatric, gene therapy, or other high-complexity indications preferred.

Responsibilities

• Provide operational leadership for Clinical Operations across all programs, from study planning and start-up through execution and close-out.
• Oversee selection, performance and governance of CROs, external vendors and service partners, ensuring consistent alignment with company standards, timelines, quality expectations, and budgets.
• Partner cross-functionally with leaders across Clinical Development Operations, Regulatory Affairs, Medical, Biostatistics, Medical Affairs, and other key functions to drive integrated program delivery.
• Provide oversight of the framework for defining, reviewing, and acting on key performance indicators (KPIs) and risk management plans, ensuring proactive issue escalation and alignment between Clinical Operations, Clinical Outsourcing, and Quality.
• Build, mentor, and empower a high-performing Clinical Operations organization, fostering accountability and professional growth.
• Lead or contribute to regulatory submission strategies (e.g., NDA, BLA, MAA) and provide operational leadership during inspections and health authority interactions.
• Champion a culture of quality, operational excellence, and collaboration across the organization.
• Oversee the implementation of best practices and industry standards in clinical operations, maintaining up-to-date SOPs and continuous process improvement initiatives.
• Support the SVP, Clinical Development Operations in strategic planning, governance meetings, and executive decision-making; act as deputy when required.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive