Associate Director, Clinical Science

Position Purpose

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.

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 Clinical Development Plans, Protocol Concepts and Full Protocols, Investigator Brochures, Briefing Documents, Safety Updates, IND/NDA submission documents, Responses to Health Authorities Inquiries and Clinical Study Reports
• 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
• Develop expertise in core clinical assessments incorporated in clinical studies and provide education and training to key stakeholders, including at investigator meetings
• 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, 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