Stoke Therapeutics · 1 month ago
Vice President, DMPK & Biomarker Development
Bedford, MA
Full-time
Hybrid
Director/Executive
$330K/yr - $365K/yr
18+ years expStoke Therapeutics is a biotechnology company focused on RNA medicine aimed at restoring protein expression. The Vice President of DMPK & Biomarker Development will provide strategic leadership in DMPK and biomarker discovery to support programs from early discovery through clinical development.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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
Qualification
Required
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 and implementing biomarker strategies to inform drug development across preclinical and clinical stages is essential
Established in leadership role overseeing teams and representing the function to both internal stakeholders
Demonstrated track record of advancing oligonucleotide therapeutics-based programs from early discovery through clinical development and regulatory filings
Knowledge of FDA/EMA/ICH guidelines to support GxP work in DMPK
Experience in overseeing CROs, external consultants, and working with cross-functional program teams
Strong leadership, team building, and communication skills; ability to guide functions and levels
Preferred
Experience in working with therapies targeting neurology is desirable
Benefits
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
Participation in our Employee Stock Purchase Program (ESPP)
Company
Stoke Therapeutics
Stoke is developing antisense oligonucleotide medicines that target RNA splicing to increase gene expression for treatment.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$360.1MKey Investors
Apple Tree Partners
2024-03-27Post Ipo Equity· $125M
2020-11-24Post Ipo Equity· $105.1M
2019-06-19IPO
Leadership Team
Edward Kaye
CEO & Founder
Adrian Krainer
Co-founder & Director
Recent News
BioWorld Financial Watch
2026-01-15
2026-01-13
2026-01-12
Company data provided by crunchbase