Stoke Therapeutics
Associate Director/Director, Clinical Science- Data Strategy and Analysis
Stoke Therapeutics, Bedford, Massachusetts, us, 01730
About Stoke
Stoke Therapeutics
(Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. 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 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.
Stoke's initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).
Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach.
Position Purpose The Associate Director/Director, Clinical Science will serve as a scientific and analytical leader, working cross-functionally to define, plan, and execute key clinical data analyses to support clinical development and publication strategy, regulatory submissions and other integrated activities.
The successful candidate will bring a strong foundation in clinical science and data analysis, with a demonstrated ability to translate scientific questions into visual figures and tables. The Associate Director/Director of Clinical Science will be a key liaison between clinical development, biostatistics, data management, medical affairs/publications, communications and regulatory affairs, driving analytical deliverables across multiple studies and programs.
This role also includes broader clinical scientist responsibilities including leading strategic clinical development initiatives across multiple indications. This individual will provide key input into clinical development activities that include trial design and development of clinical study documents and communications, focusing on data collection and data interpretation. This position will report into the Senior Director, Clinical Science.
Key Responsibilities Clinical Data Analysis Strategy (Primary Focus):
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
Collaborate with biostatistics, and data management to access, structure, and interpret clinical trial datasets and TLFs
Perform and/or support exploratory and ad hoc analyses to support internal discussions, publications/communications and regulatory responses
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
Clinical Science Responsibilities:
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 and rare disease indications highly preferred
Strong knowledge of FDA/EMA/ICH requirements and good clinical practice
Strong analytical ability including familiarity with TLFs/statistical outputs and proficiency in data analysis tools (e.g., Prism, RStudio, JMP)
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.
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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates:
Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center.
For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx.
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.
#J-18808-Ljbffr
(Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. 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 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.
Stoke's initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).
Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach.
Position Purpose The Associate Director/Director, Clinical Science will serve as a scientific and analytical leader, working cross-functionally to define, plan, and execute key clinical data analyses to support clinical development and publication strategy, regulatory submissions and other integrated activities.
The successful candidate will bring a strong foundation in clinical science and data analysis, with a demonstrated ability to translate scientific questions into visual figures and tables. The Associate Director/Director of Clinical Science will be a key liaison between clinical development, biostatistics, data management, medical affairs/publications, communications and regulatory affairs, driving analytical deliverables across multiple studies and programs.
This role also includes broader clinical scientist responsibilities including leading strategic clinical development initiatives across multiple indications. This individual will provide key input into clinical development activities that include trial design and development of clinical study documents and communications, focusing on data collection and data interpretation. This position will report into the Senior Director, Clinical Science.
Key Responsibilities Clinical Data Analysis Strategy (Primary Focus):
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
Collaborate with biostatistics, and data management to access, structure, and interpret clinical trial datasets and TLFs
Perform and/or support exploratory and ad hoc analyses to support internal discussions, publications/communications and regulatory responses
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
Clinical Science Responsibilities:
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 and rare disease indications highly preferred
Strong knowledge of FDA/EMA/ICH requirements and good clinical practice
Strong analytical ability including familiarity with TLFs/statistical outputs and proficiency in data analysis tools (e.g., Prism, RStudio, JMP)
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.
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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates:
Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center.
For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx.
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.
#J-18808-Ljbffr