Clinical Development Operations Program Lead

Clinical Development Operations Program Lead

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.

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

• 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 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.

Required Skills & Experience

• 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.
• Willingness to travel as needed (approximately 15%).

Location(s)

Stoke is in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position, currently based in Bedford and will later be based in Waltham.

Travel

This position will require approximately 15% travel.

Compensation & Benefits

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $236,000 - $260,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes 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 and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.