The posting
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 TANGO (Targeted Augmentation of Nuclear Gene Output) approach, 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’s initial focus are 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 Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/
Position Overview
We are seeking a dynamic, experienced Head of Translational Development to lead the strategy connecting preclinical research with clinical development across a growing portfolio of RNA based therapeutics. This individual will oversee clinical pharmacology, pharmacokinetics, translational biomarkers, regulated bioanalysis, and antidrug antibody assessment.
The successful candidate will bring deep expertise in translating preclinical data into clinical development strategies, informing dose selection, establishing exposure response relationships, and generating evidence to support clinical and regulatory decision making.
The portfolio includes clinical-stage assets in rare central nervous system indications. The ideal candidate combines broad scientific expertise and industry perspective with strong organizational leadership and the ability to communicate effectively with executive leadership, regulatory authorities, and cross functional teams.
This leader will partner closely with research, nonclinical development, clinical development, regulatory affairs, biostatistics, CMC, and program management. The ideal candidate combines scientific depth with strategic leadership and can guide programs from preclinical development through clinical execution and regulatory submission. As a senior R&D leader, this individual will lead and develop the translational development team, help shape R&D priorities and broader corporate strategy, and champion novel translational science.
Key Responsibilities
- Establish and lead an integrated translational development strategy across preclinical and clinical stage programs.
- Establish vision and provide strategic and organizational enterprise leadership across the translational team, including clinical pharmacology, pharmacokinetics, translational biomarkers, regulated bioanalysis, and immunogenicity assessment.
- Serve as the senior translational development and clinical pharmacology expert for cross functional program teams and executive leadership.
- Communicate the translational medicine strategy, program risks, and development recommendations clearly to executive leadership and other key stakeholders, including presentations to the executive leadership team and Board of Directors.
- Contribute translational development perspectives to R&D priorities, portfolio decisions, and broader corporate strategy.
- Translate clinical pharmacology, toxicology, DMPK, biomarker, and bioanalytical findings into clinical development strategies.
- Develop clinical starting dose, dose escalation, dose optimization, and regimen selection strategies.
- Lead pharmacokinetic, pharmacodynamic, exposure response, and population pharmacokinetic analyses.
- Integrate clinical pharmacology and translational data to support patient selection, target engagement, proof of mechanism, and clinical proof of concept.
- Establish biomarker strategies spanning preclinical model development, clinical assay implementation, and interpretation of patient data.
- Oversee regulated bioanalytical strategy, including assay development, validation, sample analysis, vendor selection, and data interpretation.
- Direct antidrug antibody and broader immunogenicity assessment strategies for advanced therapeutic modalities.
- Ensure translational findings are incorporated into clinical protocols, investigator brochures, development plans, regulatory documents, and program decisions.
- Represent translational development and clinical pharmacology in interactions with global regulatory authorities.
- Contribute to IND, NDA, and other regulatory submissions, including the preparation and review of clinical pharmacology, biomarker, and bioanalytical content.
- Provide scientific and strategic oversight across Discovery to Early Development transition, diverse therapeutic programs, ensuring the delivery of relevant translational models, clinical pharmacology strategies, and support of clinical stage programs
- Advance novel translational science and build productive relationships with KOLs and other external scientific leaders.
- Represent the organization at scientific congresses and support the presentation and publication of translational findings.
- Evaluate and proactively manage external partners, including contract research organizations, consultants, and scientific collaborators, to ensure timely execution, adherence to budget and overall operational excellence
- Identify translational risks, data gaps, and critical scientific questions while recommending practical solutions aligned with program priorities and urgency for patients.
- Serve as a key pillar of the R&D leadership team, helping define and execute the company’s drug development vision and strategy while driving a collaborative, egalitarian culture driven by scientific rigor, excellence, accountability, portfolio focus, and patient impact and defined by kindness and mutual respect.
Candidate Qualifications
- Advanced degree in clinical pharmacology, pharmacokinetics, pharmaceutical sciences, biomedical sciences, or a related discipline; PhD, PharmD, or MD preferred.
- Significant translational development and clinical pharmacology leadership experience within biotechnology or pharmaceutical drug development required.
- Demonstrated success managing and developing technically strong scientific leaders and multidisciplinary teams, building talent, strengthening leadership capabilities, and fostering a culture of scientific rigor, excellence, collaboration, and accountability.
- Experience contributing scientific and translational perspectives to broader R&D and corporate strategy.
- Deep expertise in clinical pharmacology and pharmacokinetics, including dose selection, exposure response analysis, population pharmacokinetics, and pharmacokinetic and pharmacodynamic modeling.
- Experience supporting both preclinical and clinical stage development programs required.
- Demonstrated expertise across the development continuum and ability to translate preclinical findings into clinical development, biomarker, and dose optimization strategies.
- Experience developing and implementing translational biomarker strategies across preclinical and clinical programs.
- Strong knowledge of regulatory process and stage-appropriate expectations for bioanalysis, including assay development, validation, vendor oversight, and regulatory requirements.
- Experience developing and interpreting antidrug antibody and immunogenicity assessment strategies.
- Experience contributing to global regulatory interactions and clinical pharmacology components of regulatory submissions required.
- Demonstrated success working across the spectrum of functional partners, including research, nonclinical development, clinical development, regulatory affairs, biostatistics, CMC, program management, commercial, and medical affairs.
- Broad, enterprise-oriented perspective with a collaborative approach to decision making and demonstrated experience helping set and execute strategy as part of an R&D leadership team.
- Experience leading programs through late-stage development, regulatory approval, or product launch strongly preferred.
- Direct experience developing advanced modalities strongly preferred but not required.
- Experience with advanced therapeutic modalities beyond traditional small molecules preferred.
- Clinical development experience in rare central nervous system indications preferred.
- Strong executive presence with the ability to communicate complex scientific and quantitative concepts to senior leadership.
- Track record of advancing novel science and engaging externally with KOLs, including experience presenting at scientific congresses and contributing to scientific publications.
- Ability to operate effectively in both large pharmaceutical organizations and smaller, resource conscious biotechnology environments.
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 $322,00 - $374,00. 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.
