Associate Director, Clinical Science

Stoke Therapeutics•Bedford, MA

1d•$200,000 - $245,000•Hybrid

About The Position

The Associate Director, Clinical Science will advance Stoke Therapeutics’ clinical programs by working with cross-functional teams to define medical data review requirements, ensure data quality, and interpret data to support program strategy. The role contributes to and authors regulatory documents, publications, and presentations; supports or leads clinical protocol design; serves as a subject matter expert in clinical outcome assessments and endpoint measures; and provides training to investigators and study teams. The position provides scientific leadership across cross-functional teams, partnering with medical directors, data management, clinical operations, regulatory, medical affairs, and external stakeholders to align program and study documents, support endpoint strategy, and provide scientific input. It reports to the Senior Director, Clinical Science. The role has a flexible work arrangement with regular presence at the Waltham office, generally a couple of days most weeks, and requires approximately 5% travel.

Requirements

Advanced degree (e.g., M.S., PharmD, Psy.D., or Ph.D.) in a life science, clinical research, or similar field.
At least 5 years of clinical drug development experience.
Proficient knowledge and skills to support clinical trial data review, trend identification, and data interpretation.
Experience collaborating closely with data management and biostatistics/programming teams.
Exceptional written and oral communication skills tailored to varied audiences.
Ability to work independently and collaboratively in a dynamic, fast-paced environment with internal and external team members.
Strong interpersonal skills to work closely with a broad range of stakeholders, from investigators to internal teams.
Attention to detail and commitment to high-quality work.
Strong planning, organization, and time-management skills, including the ability to prioritize multiple complex initiatives.
Passion and urgency to achieve goals and improve patients’ lives.

Nice To Haves

Experience in neurology indications or experience interpreting clinical outcome assessments of neurodevelopment, cognition, adaptive functioning, and behavior (e.g., BSID-IV, WPPSI-IV, Vineland-3).

Responsibilities

Lead cross-functional efforts to identify clinical data analysis needs across studies and programs.
Define and drive clinical data analysis strategy to support clinical decision-making, safety and efficacy evaluation, publications and communications, and regulatory filings.
Lead exploratory and ad hoc analyses that support the clinical data analysis strategy.
Ensure analytical outputs align with scientific objectives and regulatory expectations, maintaining data integrity and consistency across documents.
Present complex data findings clearly to cross-functional teams and external audiences as needed.
Develop, co-author, and review strategic documents, including Clinical Development Plans, Protocol Concepts and Full Protocols, Investigator Brochures, Briefing Documents, Safety Updates, IND/NDA submission documents, responses to health authority inquiries, and Clinical Study Reports.
Serve as an interface between clinical development and internal functions—including clinical development operations, data management, biostatistics, regulatory, program management, and DMPK/biomarkers—as well as external teams for clinical-development-initiated projects.
Develop expertise in core clinical assessments used in studies and educate and train stakeholders, including at investigator meetings, as needed, to support quality completion.
Support medical monitoring, including eligibility review, safety data review, and trend identification.
Collaborate with functions such as data management to improve processes for timely and efficient internal clinical data review.
Build effective working relationships with stakeholders, including investigators, to optimize scientific quality and innovation in clinical study design, execution, reporting, and publication.
Represent clinical development at advisory boards, investigator meetings, site initiations, and other external engagements.
Attend scientific meetings to interact with investigators and advisors and present clinical data as needed.