Senior Director, Regulatory Labeling Development and Advertising & Promotional en Stoke Therapeutics
Stoke Therapeutics · Bedford, Estados Unidos De América · Hybrid
- Senior
- Oficina en Bedford
About Stoke:
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 Senior Director, Regulatory Labeling, Advertising & Promotion will serve as an expert on FDA regulations, guidance, and enforcement trends governing the labeling development and promotion of Stoke’s products. Provides regulatory oversight to ensure regulatory compliance of promotional materials generated for assigned investigational medicinal products and subsequently approved products. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. This position will report into the Chief Regulatory Officer.
Key Responsibilities:
- Responsible for strategy, development, and implementation of labeling as well as systems to manage labeling lifecycle.
- Provide label strategies to ensure claims can be supported by development.
- Lead cross-functional Labeling teams to align labeling strategy and content.
- Develop and maintain the target product profile, the company core datasheet, the patient labeling, the USPI, and the summary of product characteristics or international equivalents.
- Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
- Interpret regulations and guidance relevant to the development and implementation of labeling.
- Provide strategic oversight to ensure promotional materials and non-promotional materials generated for external communication regarding commercialized products and/or compounds in development adhere to regulatory compliance standards.
- Develop systems for material content review and approval.
- Provide regulatory input and guidance to relevant stakeholders regarding marketing strategies, promotion objectives, and plans.
- Represent regulatory at promotional review meetings to assist commercial with development of compliant promotional materials.
- Primary liaison with FDA’s OPDP.
- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, Ad Agencies, and Compliance to ensure alignment and effective execution of corporate objectives while mitigating potential regulatory risk.
Required Skills & Experience:
- A BS/BA degree or equivalent, and a minimum of 12 years’ experience in Regulatory Affairs specific to Regulatory Affairs Labeling, Advertising and Promotion.
- Knowledge of applicable regulations and regulatory guidance specific to labeling, advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Proven ability to manage multiple complex projects, with the flexibility and adaptability to re-prioritize workload.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
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.
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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center.
For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx.
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.
