Clinical Development Operations Program Lead

Stoke Therapeutics•Bedford, MA

2h•$236,000 - $260,000•Hybrid

About The Position

Stoke Therapeutics is a biotechnology company focused on restoring protein expression using RNA medicine. Their proprietary TANGO approach develops antisense oligonucleotides (ASOs) to selectively restore natural protein levels. The company's first medicine, zorevunersen, is in a Phase 3 study for Dravet syndrome. Stoke's primary focus is on central nervous system and eye diseases caused by haploinsufficiency, with potential applications in other areas. The company is headquartered in Bedford, Massachusetts.

Requirements

Bachelor’s degree required; advanced degree preferred.
10+ years of clinical operations and clinical development operations program management experience, including hands-on trial management and strong understanding of the end-to-end drug development process.
Demonstrated experience leading clinical programs in an outsourced CRO model.
Strong Strategic mindset with proactive risk management and solution / results orientated.
Strong knowledge of GCP, global regulatory requirements, and inspection-readiness expectations.
Demonstrated ability to work cross functionally and lead with influence and motivating others.
Excellent communication, organizational, and problem-solving skills.
Ability to operate independently, manage complexity, and drive execution in a fast-paced environment.

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; proactively identify and escalate issues with proposed mitigations.
Provides 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.
Proactively identify program risks and mitigations, work with cross-functional teams to develop contingency plans and escalate to the Sr. Director, Clinical Development Operations Program Lead.
Execute program delivery within established Clinical Development Operations standards, processes, and vendor governance frameworks.
Collaborate with external development partners to support alignment on program-level operational plans, timelines, and execution.
Supports the Clinical Study Teams in holding CROs and vendors accountable for program-level performance, quality, timelines, and budget adherence.
Coordinate resolution of program-specific CRO or vendor performance issues in collaboration with study teams and functional partners. Escalate systemic or cross-program vendor issues to the Senior Director.
Support development and monitoring of program-level clinical budgets, ensuring alignment between operational plans, resourcing assumptions, and program priorities, and escalating financial risks as needed.
Provide program-level operational status reporting, including timelines, risks, and key trade-offs, and prepare materials for program governance forums and milestone reviews.
Support program readiness for audits and inspections by maintaining clear documentation of program status, risks, and key operational decisions.
Lead program-level operational status reporting, including timelines, risks, and trade-offs.
Prepare materials for program governance forums and milestone reviews.
Provide program-level leadership and coordination across study-level operational teams to support effective execution of clinical development programs.
Foster a collaborative and accountable working environment across internal teams, CRO partners, clinical vendors, and functional stakeholders.
Support onboarding of new team members and external partners to the program, ensuring alignment with program objectives and priorities.