Vice President, DMPK & Biomarker Development

Vice President, DMPK & Biomarker Development 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 approach, the company 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.

STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Stoke’s initial focus is on 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 the Company’s proprietary approach.

Reporting to SVP of Translational DMPK and Clinical Pharmacology, this leadership role will be responsible for providing strategic and scientific leadership for DMPK and biomarker discovery and development to support the programs from early discovery through clinical development.

• To ensure that DMPK/ADME and biomarker data inform key decisions to support regulatory submissions.
• Drive the DMPK strategy for new programs and support the functional leads for INDs/CTAs. Oversee related authorship and review of key regulatory documents and engagement with global health authorities.
• Provide thought leadership and decision-making support on IND readiness.
• Collaborate with clinical development team and author and review the relevant sections of IBs, clinical study protocols, CSRs and NDAs/BLAs.
• Contribute on and provide leadership to discovery-stage project teams as a subject matter expert, providing PK and PK/PD input to the design of preclinical studies and predict clinical outcomes.
• Collaborate with R&D team and toxicologist to guide dose selection in preclinical studies, dose/exposure rationale, and safety margins.
• Ensure that appropriate guidance from regulatory agencies is utilized to support GxP work overseen by DMPK team.
• Direct in vitro and in vivo DMPK studies, to enable and inform clinical modeling and translational assessments.
• Lead the integration of biomarker strategies into preclinical and clinical programs to inform drug response, PK/PD modeling and potentially patient stratification.
• Lead integration of bioanalysis, toxicokinetics, and potentially biomarker strategy into nonclinical programs to inform clinical development and regulatory submissions.
• Collaborate with the SMEs and mentor scientists in DMPK team.
• Identify new and manage existing consultants to support DMPK studies.
• Maintain or develop expertise in evolving clinical pharmacology and pharmacometrics approaches.
• Assist in forecasting resources and the department budget.
• Represent the company in external scientific forums, collaborations, and regulatory interactions.
• Excellent communication skills, including the ability to present complex scientific concepts and make actionable recommendations to the team.

• PhD in a scientific discipline with 18+ years of work experience in academia and industry, that is related to drug discovery and development.
• In depth understanding of DMPK and proven track record of leading DMPK strategies.
• Background in developing…