Clinical Development Operations Program Lead
Stoke Therapeutics
August 19, 2026
Remote friendly (Bedford, MA)
United States
Operations
Position Purpose:
- Drive clinical development operations program oversight and end-to-end operational execution of clinical development programs; primary program-level development operations lead and co-lead of the Development Sub Team, translating strategy into executable global plans and delivering timely, high-quality clinical milestones.
Key Responsibilities:
- Lead integrated development operations plan; translate strategy into operational plans, timelines, and resourcing models.
- Manage program-level risks/dependencies/critical path; identify and escalate issues with mitigations.
- Oversee CRO/vendor/site performance metrics; hold partners accountable for performance, quality, timelines, and budget adherence.
- Lead Development Sub-Team; serve as Clinical Development Operations Lead in the Core Program Team.
- Support development/monitoring of program budgets; escalate financial risks.
- Provide program-level operational status reporting for governance/milestone reviews; maintain documentation for audits/inspections.
- Provide leadership and coordination across study-level operational teams; support onboarding of team members/external partners.
Required Skills & Experience:
- Bachelor’s degree required; advanced degree preferred.
- 10+ years in clinical operations/clinical development operations program management; hands-on trial management; strong end-to-end drug development knowledge.
- Experience leading clinical programs in an outsourced CRO model.
- Strong strategic risk management; GCP and global regulatory knowledge; inspection-readiness.
- Cross-functional leadership/influence; excellent communication/organization/problem-solving.
- Ability to operate independently and manage complexity; travel ~15%.
Compensation & Benefits:
- Annual bonus and equity participation; medical/dental/vision; life and long-/short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
- Apply via Stoke’s Career Center: https://www.stoketherapeutics.com/careers/
- Drive clinical development operations program oversight and end-to-end operational execution of clinical development programs; primary program-level development operations lead and co-lead of the Development Sub Team, translating strategy into executable global plans and delivering timely, high-quality clinical milestones.
Key Responsibilities:
- Lead integrated development operations plan; translate strategy into operational plans, timelines, and resourcing models.
- Manage program-level risks/dependencies/critical path; identify and escalate issues with mitigations.
- Oversee CRO/vendor/site performance metrics; hold partners accountable for performance, quality, timelines, and budget adherence.
- Lead Development Sub-Team; serve as Clinical Development Operations Lead in the Core Program Team.
- Support development/monitoring of program budgets; escalate financial risks.
- Provide program-level operational status reporting for governance/milestone reviews; maintain documentation for audits/inspections.
- Provide leadership and coordination across study-level operational teams; support onboarding of team members/external partners.
Required Skills & Experience:
- Bachelor’s degree required; advanced degree preferred.
- 10+ years in clinical operations/clinical development operations program management; hands-on trial management; strong end-to-end drug development knowledge.
- Experience leading clinical programs in an outsourced CRO model.
- Strong strategic risk management; GCP and global regulatory knowledge; inspection-readiness.
- Cross-functional leadership/influence; excellent communication/organization/problem-solving.
- Ability to operate independently and manage complexity; travel ~15%.
Compensation & Benefits:
- Annual bonus and equity participation; medical/dental/vision; life and long-/short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
- Apply via Stoke’s Career Center: https://www.stoketherapeutics.com/careers/