New · posted Nov 14
Stoke Therapeutics · Biotechnology
Associate Director, Clinical Science
- Bedford, MA
- Hybrid
- Full-time
- Director
The role
The Associate Director, Clinical Science will play a pivotal role in advancing Stoke's ongoing clinical programs. The Clinical Scientist will work with the cross-functional team to define medical data review requirements that ensure data quality and interpret data to support strategy. They will contribute/author regulatory documents, publications, and presentations that accurately communicate study results. The Clinical Scientist will support or lead design of clinical protocols, serve as the subject matter expert in clinical outcome assessments and endpoint measures and will provide training for investigators and study teams as needed.
The Clinical Scientist will provide scientific leadership across cross-functional teams. They will partner with the cross-functional team including 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 across program and study level activities. This position will report into the Senior Director, Clinical Science.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
What you need
Required Skills & Experience
- Advanced degree required (e.g., M.S., PharmD, Psy.D. or Ph.D. ) in a life science, clinical research or another similar field
- 5+ years of clinical drug development experience
- Experience in neurology indications or experience with interpretation of clinical outcome assessments of neurodevelopment, cognition, adaptive functioning and behavior (eg, BSID-IV, WPPSI-IV, Vineland-3) is preferred
- Proficient knowledge and skills to support clinical trial data review, trend identification, data interpretation
- 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 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
Skills named in this posting
- Clinical drug development (5+ years)
- Advanced degree (M.S., PharmD, Psy.D., Ph.D.)
- Clinical trial data review and interpretation
- Protocol and clinical study report authoring
- IND/NDA submission documents
- Clinical outcome assessments (neurology)
- Collaboration with data management and biostatistics
- Written and oral communication
What you'll do
- 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
Pay and benefits
$200,000 – $245,000 a year
Employer providedAt Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
The anticipated salary range for this role is $200,000 - $245,000. 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).
Medical, dental and vision insurance
Life and disability insurance
Paid parental leave
401(k) with company match
Unlimited vacation
Employee Stock Purchase Program
Where you'll work
Bedford, MAHybridOpen in Maps (opens in a new tab)
More jobs in Bedford, MAWorking conditions
Travel
This position will require approximately 5% travel.
Location(s)
This position has a flexible work arrangement, with regular presence at our Waltham office, which we will be moving to in January 2026. At Stoke, we value in-person time together for the work that benefits most from it. Expect to be in the office a couple of days most weeks.
From the posting
About Stoke Therapeutics
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/
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.
Culture & Values
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/.
Equal opportunity, accessibility and legal noticesStoke Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 26% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts69 roles publishing pay
Director roles in the US219 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $245,000 |
| Massachusetts (middle half) | $235,500 | $297,000 | $320,000 |
| All US (middle half) | $253,000 | $300,000 | $335,500 |
This role: Stoke Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 292 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Stoke Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- Clinical trial conduct10
- Investigations and CAPA7
- Documentation and SOPs6
- Data and digital systems5
- Lab testing and methods1
- Regulatory submissions1
- Clinical drug development (5+ years)
- Advanced degree (M.S., PharmD, Psy.D., Ph.D.)
- Clinical trial data review and interpretation
- Protocol and clinical study report authoring
- IND/NDA submission documents
- Clinical outcome assessments (neurology)
- Collaboration with data management and biostatistics
- Written and oral communication
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
Company hiring pulse
Stoke Therapeutics on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 1
- Locations
By discipline
- Clinical5 56%
- Regulatory3 33%
- Quality1 11%
By level
- Director5 56%
- VP & Executive2 22%
- Manager2 22%
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Associate Director, Clinical Science at Stoke Therapeutics
Open until filled. $200K–$245K a year, employer provided.