Vice President, Clinical Operations

Vice President, Clinical Operations at Stoke Therapeutics. 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 approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Zorevunersen, Stoke’s first medicine in development, 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, and 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. Position Purpose 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. Key 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. Required Skills & Experience 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. Prior experience in rare disease, pediatric, gene therapy, or other high‑complexity indications preferred. 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 programmes 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. Location(s) Stoke operates sites in Bedford, MA. This position is a hybrid/remote‑based position that will require a consistent presence in our office at least 3 days a week. Travel Approximately 15% 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 $311,000 - $374,000. 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. Medical, dental and vision insurance Life, long‑term and short‑term disability insurance Paid parental leave 401K plan with company match Unlimited vacation time Tuition assistance 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. Job Details Seniority Level: Executive Employment Type: Full‑time Job Function: Research, Analyst, and Information Technology Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center. https://www.stoketherapeutics.com/careers/ For more information, visit https://www.stoketherapeutics.com/. 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. #J-18808-Ljbffr