Strategic Clinical Development Operations Program Lead

Socket.dev; Bedford (MA); Hybrid; USD 236,000 - 260,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life, long‑ and short‑term disability

Paid parental leave

401K plan with company match

Unlimited vacation time

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, is seeking a Director of Development Operations Program Lead to oversee end-to-end clinical development program execution in a highly outsourced model. The role requires translating strategy into executable global plans and ensuring timely delivery of milestones.

The candidate will lead program-level decisions, manage risks, and collaborate with CROs and vendors to maintain quality, timelines, and budgets, reporting to the Senior Director.

Qualifications

• 10+ years of clinical operations and clinical development operations program management experience.
• Demonstrated experience leading clinical programs in an outsourced CRO model.
• Strong strategic mindset with proactive risk management and results orientation.
• Strong knowledge of GCP, global regulatory requirements, and inspection-readiness expectations.

Responsibilities

• Lead the integrated development operations plan for a clinical development program or defined group of studies.
• Translate clinical development strategy into detailed operational plans, timelines, and resourcing models.
• Manage program-level risks, dependencies, and critical path activities; mitigate issues with proposed mitigations.
• Provide oversight of CRO, vendor, and site performance metrics within the clinical program.
• Lead Development Sub-Team and serve as Clinical Development Operations Lead in the Core Program Team.
• Identify program risks and develop contingency plans with cross-functional teams.
• Execute program delivery within established Clinical Development Operations standards and governance.
• Collaborate with external development partners on alignment of plans and execution.

Skills

Clinical Development Operations

Program management

GCP knowledge

Outsourced CRO experience

Cross-functional leadership

Education

Bachelor’s degree

Advanced degree preferred

Job description

Stoke Therapeutics, headquartered in Bedford, MA, is seeking a Director of Development Operations Program Lead to oversee end-to-end clinical development program execution in a highly outsourced model. The role requires translating strategy into executable global plans and ensuring timely delivery of milestones.

The candidate will lead program-level decisions, manage risks, and collaborate with CROs and vendors to maintain quality, timelines, and budgets, reporting to the Senior Director.