Stoke Therapeutics · 2 months ago
Vice President, Clinical Operations
Bedford, Massachusetts, United States
Full-time
Hybrid
Director/Executive
$311K/yr - $374K/yr
20+ years expStoke Therapeutics is a biotechnology company dedicated to restoring protein expression through RNA medicine. The Vice President of Clinical Operations will provide leadership for global clinical trial operations, ensuring studies are conducted in accordance with regulatory requirements and strategic goals.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
Bachelor's or advanced degree in Life Sciences or a related field
Approximately 20 years of progressive experience in Clinical Operations
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
Preferred
Prior experience in rare disease, pediatric, gene therapy, or other high-complexity indications
Benefits
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)
Company
Stoke Therapeutics
Stoke is developing antisense oligonucleotide medicines that target RNA splicing to increase gene expression for treatment.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$360.1MKey Investors
Apple Tree Partners
2024-03-27Post Ipo Equity· $125M
2020-11-24Post Ipo Equity· $105.1M
2019-06-19IPO
Leadership Team
Edward Kaye
CEO & Founder
Adrian Krainer
Co-founder & Director
Recent News
BioWorld Financial Watch
2026-01-15
2026-01-13
2026-01-12
Company data provided by crunchbase