Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiency, which are disease caused by a loss of about half of the normal protein function. Rather than replace, repair, or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing the broad potential for our approach to helping people with severe diseases.
The early results have been promising. Stoke’s first medicine in development, STK-001 has demonstrated positive Phase 1/2 results for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy that is associated with a number of debilitating non-seizure comorbidities. Behind that, is STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential treatments for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts.
The Director/Senior Director of Regulatory Affairs reports to the Chief Regulatory Officer & SVP Quality and will be responsible for developing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio. This role will provide regulatory support for various departments, projects, and teams.
Leads the development and implementation of regulatory strategy and activities for assigned programs.
Represents RA in product development project teams advising on timelines, regulations, processes, and requirements.
Serves as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
Provides regulatory guidance from early stage (pre-IND/CTA) through commercialization
Identifies and evaluates regulatory risks and establishes risk mitigation
Plans and executes successful regulatory agency meetings and interactions per regulatory strategy
Develops and implements global regulatory strategies and plans for assigned programs.
Initiates and plans health authority meetings with global regulatory agencies.
Prepares and delivers effective presentations for external and internal audiences.
Contributes to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise
Identifies and monitors regulatory and policy issues
Develops risk assessment plans; Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation)
Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes, and SOPs, and approves and ensures implementation to establish a compliant culture.
Required Skills & Experience:
M.S. or Ph.D. in Life Sciences or related degree preferred
7-8 years minimum of pharmaceutical/biotechnology industry experience in a Regulatory Affairs lead role.
Experience in rare disease drug development would be ideal.
Experience and comfort with a fast-paced biotech company environment.
Experience in working with US, EU, and Japanese Regulatory Agencies is highly desirable.
Knowledge and experience in the interpretation of regulations, guidelines, policy statements, etc.
Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs, including both clinical and pre-clinical aspects of the project; direct experience in interfacing with relevant regulatory authorities.
Proven ability to foster effective, positive interactions with regulatory agencies, and corporate partners.
Proven ability to demonstrate excellent leadership and communication skills.
Demonstrated strong organizational skills.
Strong interpersonal skills and proven ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
Well organized, self-motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail-oriented, with effective written and oral communication skills.
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 individuals’ 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 to 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.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Cambridge, MA location.
This position will require approximately 10% travel.
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 https://www.stoketherapeutics.com/ or follow the company on Twitter 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.