Senior Director, Regulatory Writing and Operations

Title: Senior Director, Regulatory Writing and Operations

Location: Bedford United States

Job Description:

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 approach, the company 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 entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights

STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Stoke’s initial focus is on 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 the Company’s proprietary approach.

Position Purpose:

The Senior Director, Regulatory Writing and Operations oversees the strategic direction and management for both the Regulatory Writing and Regulatory Operations functions within Stoke.  This position is responsible for the preparation, collaborative authoring, and completion of ICH-compliant regulatory documents, including those for clinical. Additionally, this position oversees submission and document management, publishing, and the Regulatory Information Management System (RIM). Demonstrates excellent understanding of drug development and leadership behaviors consistent with level.  This position will report into the Chief Regulatory Officer.

Key Responsibilities:

• Partners with stakeholders to author complex regulatory documents including but not limited to; clinical study protocols, clinical study reports, investigator’s brochures, regulatory briefing packages, regulatory responses, and sections of marketing authorization applications.
• Develop and manage SOPs, editorial standards, internal templates, and style guides.
• Partner with peers to increase visibility of upcoming submissions and deliverables across the regions.
• Work directly with team members to communicate and drive timelines, lead document review and roundtable discussions.  
• Provide expert review of study-level and program-level documents for consistency in messaging and formatting.
• Effectively manage workloads and product quality of internal and contract medical writers.
• Direct the development and implementation of standards (SOPs and work processes) for dossier development, management, publishing, archiving, metrics, and submission process.
• Accountable for QC and validation of submissions to ensure they are error-free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements.
• Oversee maintenance, validation, implementation and training on operations systems.
• Drive continuous process improvement and increased communications across regulatory through leadership of initiatives to capture learnings, integration of new tools and technologies, and identify opportunities for change.
• Lead or participate in process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable. 

Required Skills & Experience:

• In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents (e.g., GCP, ICH).

• Sound working knowledge of writing, publishing and RIM computer applications

• Excellent written and oral communication skills.
• Ability to manage teams and individuals.
• A BS/BA degree or equivalent, and a minimum of 10 years’ experience in Medical or Regulatory Writing.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Proven ability to lead complex projects, with flexibility and adaptability.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Location(s):

Stoke is located in Bedford, MA.  This position is a hybrid position with an office setting based in Bedford, MA location.

Travel:

This position will require approximately 5% 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 $262,000 - $299,000. 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. 

Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.