Job Description

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. 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 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

Stoke’s initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).

Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach.

Position Purpose:

The Director of Regulatory Affairs will be responsible for developing and executing global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio.  Manages compounds through all phases of development, including post approval. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level.  This position will report into the Chief Regulatory Officer.

Key Responsibilities:

• Develop and implement global regulatory strategies and plans for assigned programs.
• Develop risk assessment plans. Proactively anticipates risks and establishes risk mitigation with team and management.  
• Ensure project team colleagues, line management and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Lead regulatory sub-team and represents RA in product development project teams.
• Continually expand therapeutic area knowledge, and ensures strategic messaging and content of global regulatory dossiers.
• Lead cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Direct point of contact with health authorities, leads and manages FDA meetings.
• Prepare and deliver effective presentations for external and internal audiences on a variety of drug development topics.
• Contribute to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise.
• Monitors and anticipates industry trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Required Skills & Experience:

• 10+ years minimum of Regulatory Affairs experience in the pharmaceutical industry. Rare disease development preferred.
• BS., M.S. or Ph.D. in a scientific discipline preferred.
• Strong working knowledge of drug development processes and regulatory requirements.
• Excellent verbal, written, negotiation, and interpersonal skills.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Strong interpersonal skills and proven ability to effectively manage a variety of senior personnel including medical, scientific, and manufacturing staff.

Location(s):

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

Travel:

This position will require approximately 5% travel.