Clinical Development Operations Program Lead

About this role

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Director, Development Operations Program Lead drives the clinical development operations program oversight and is accountable for the end-to-end development operational execution of clinical development programs. This role serves as the primary development operational lead at the program level and co-leads the Development Sub Team, translating clinical development strategy into executable global plans and ensuring timely, high-quality delivery of clinical milestones.

The Director operates with a strong execution and strategic mindset, identifying and mitigating potential risks, leads program-level development operational decisions, and escalates cross-program, or portfolio level risks to the Senior Director. This role is critical to ensuring consistency, quality, and accountability across study execution in a highly outsourced model.

This position reports to the Senior Director, Clinical Development Operations Program Lead.

Key Responsibilities:

Program-Level Operational Execution

• 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.

CRO & Vendor Management

• 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.

Financial & Resource Oversight

• 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.

Reporting & Quality

• 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.

Team Leadership & Development

• Provide program-level leadership and coordinatio