Associate Director, Toxicology bei Stoke Therapeutics
Stoke Therapeutics · Bedford, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in 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 Associate Director will be responsible for preparation of preclinical safety data packages for clinical development. The ideal candidate will have extensive experience with the design, execution and interpretation of in vitro and in vivo toxicology studies. The candidate will be responsible for coordinating and interfacing with CROs to undertake these studies, and will be accountable for the review, analysis and reporting of the safety pharmacology and toxicology data. This individual will need to work across a multi-disciplinary team to advance programs through the pipeline. The successful candidate will have extensive experience of reviewing and creating regulatory documents (INDs, CTAs, NDAs etc.) and interacting with global regulatory agencies. This position will report to the Executive Director, Head of Toxicology.
Key Responsibilities:
- Provide leadership, technical oversight, and guidance for all nonclinical safety studies conducted to support discovery and development programs and ensure delivery of a high-quality safety package for development.
- Design and manage nonclinical safety studies, including the evaluation, interpretation an integration of safety pharmacology, toxicology and toxicokinetic information.
- Manage the preparation and presentation of nonclinical safety data for project teams, regulatory agencies, and management.
- Prepare toxicology sections in regulatory documents (IND, CTA, IB and annual reports) and aid in preparation of responses to regulatory agencies.
- Develop an optimal CRO network to support non-clinical safety studies and manage external CROs to conduct appropriate studies.
- Manage toxicology goals, priorities, resource requirements, budget, and timelines.
- Collaborate with Discovery Research, DMPK, Chemistry/CMC functions as well as with key Clinical and Regulatory stakeholders.
- Regularly assess the oligonucleotide drug development field and use best practice for safety studies.
- Represent Stoke Therapeutics toxicology with key external stakeholders, partners, and consultants.
Required Skills & Experience:
- M.S. similar in Pharmacology, Toxicology, or a relevant discipline and 12+ years of experience or PhD and 8+ years of experience in Toxicology or a relevant field
- Track record supporting drug discovery programs from target identification through development with small molecules and/or oligonucleotides
- Experience in all aspects of toxicology including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology
- Knowledge of FDA GLP and ICH guidelines
- Experience authoring regulatory documents and interacting with FDA and ideally, EU regulatory agencies.
- Effective management of external collaborations and service providers (CROs) and ability to bring pragmatic business minded approach to balancing internal and external capabilities.
- Familiarity with oligonucleotides or messenger RNA therapeutics
- Experience with drug development in the CNS and/or eye is a plus
- Strong organizational and recordkeeping skills.
- Strong presentational skills to be able to communicate to both internal and external audiences.
- Highly motivated cross-functional team player with the ability to work in a fast-paced environment. Ability to provide novel, innovative solutions to challenging problems.
Location(s):
Stoke is located in Bedford, MA. This position is a hybrid position with an office based in Bedford, MA location.
Travel:
This position will require approximately 10% 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 $189,000 - $258,000. 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 Committee (DIB) 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.
