Associate Director/Director, Clinical Science

Position Purpose:

The Associate Director/Director, Clinical Science will play a pivotal role in advancing Stoke's ongoing clinical programs and will serve as a scientific and analytical leader, responsible for ensuring the integrity, accuracy, and scientific rigor of clinical data. This individual will play a key role in the interpretation and communication of clinical results, supporting data-driven decision-making across ongoing programs. Working cross-functionally, the Associate Director/Director will provide critical input into data analysis plans, clinical study documentation, and scientific publications to advance Stoke’s clinical and regulatory objectives. This role will serve as a central liaison among Clinical Development, Biostatistics, Data Management, Medical Affairs, Communications and Regulatory, driving analytical deliverables across multiple studies and programs. This position will report into the Senior Director, Clinical Science.

Key Responsibilities:

• Lead cross-functional efforts to identify clinical data analysis needs across studies and programs
• Define and drive the clinical data analysis strategy to support clinical decision-making, safety/efficacy evaluation, publications and communications, and regulatory filings
• Lead the completion of exploratory and ad hoc analyses to 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 externally as needed
• Develop, co-author and review key strategic documents including but not limited to Clinical Development Plans, Protocol Concepts and Full Protocols, Investigator Brochures, Briefing Documents, Safety Updates, IND/NDA submission documents, Responses to Health Authorities Inquires and Clinical Study Reports in conjunction with other members of the clinical study/program teams as needed
• Serve as an interface for clinical studies between clinical development and multiple internal functions including clinical development operations, data management, biostatistics, regulatory, program management and DMPK/biomarkers and external teams as needed for clinical-development initiated projects
• Develop expertise in core clinical assessments incorporated in clinical studies and provide education and training to key stakeholders, including at investigator meetings, as needed, in order to ensure quality completion
• Support medical monitoring activities, including review of eligibility, safety data review and trend identification
• Collaborate with functions including data management to continuously enhance processes for the timely and efficient internal review of clinical data
• Develop effective working relationships with key 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 to present clinical data, as needed

Required Skills & Experience:

• Advanced degree required (e.g., M.S., PharmD, or Ph.D. ) in a life science, clinical research or another similar field
• At least 7 years of clinical drug development experience
• Experience in neurology indications preferred
• Strong knowledge of FDA/EMA requirements and good clinical practice
• Experience having close collaboration with data management, biostatistics/programming teams
• Exceptional written and oral communication skills tailored to varied audiences
• Proven ability to work independently and collaboratively, as required, in a dynamic, fast-paced start-up environment consisting of internal and external team members
• Strong interpersonal skills commensurate with the need to work closely with a broad range of stakeholders, from investigators to internal teams
• Attention to detail and a commitment to delivering high-quality work
• Strong planning, organization and time management skills including the ability to prioritize multiple, complex initiatives
• A sense of passion and urgency to achieve goals and improve the lives of patients

Location(s):

Stoke operates in Bedford, MA. This position is hybrid position with an office setting based in our Bedford, MA location.

Travel:

This position will require approximately 5% 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 at the Associate Director level is $196,000 - $213,000 and at the Director level is $223,000 - $242,000. 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).