Vice President, Clinical Operations

Stoke Therapeutics, Inc.-posted about 1 month ago
$311,000 - $374,000/Yr
Full-time • Executive
Hybrid • Bedford, MA
101-250 employees
Professional, Scientific, and Technical Services
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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.

  • 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.
  • 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.
  • Prior experience in rare disease, pediatric, gene therapy, or other high-complexity indications preferred.
  • 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
  • participation in our Employee Stock Purchase Program (ESPP)
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