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Stoke TherapeuticsCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading global clinical trials, managing CROs and vendors, and ensuring compliance with ICH-GCP guidelines. Proficient in clinical study budgeting, risk management, and maintaining study timelines while collaborating with cross-functional teams.
Highest-signal resume keywords
Global Clinical Trial LeadershipCRO ManagementICH-GCP KnowledgeClinical Study BudgetingPediatric Rare Disease Experience
About the role
Key responsibilities & impact- Lead cross-functional clinical study teams and manage all aspects of assigned global clinical studies
- Oversee partner CROs and vendors to ensure studies follow protocol, GCP, timelines, and budget under the Clinical Development Plan
- Lead study feasibility, site and country selection, and timely site activation
- Oversee vendor selection, qualification, setup, and required user acceptance testing
- Provide input into clinical study protocols, informed consent forms, and other study documents
- Oversee operational plans to maintain study compliance and quality
- Develop and maintain study timelines and collaborate with internal functional stakeholders
- Identify study risks and coordinate mitigations with the study team, CROs, and vendors
- Coordinate study status updates with internal stakeholders
- Coordinate with CMC on drug forecasting and supply to clinical sites
- Support database locks through monitoring plans and data review/reconciliation
- Support clinical study budgeting, accruals, and forecasts
- Participate in scenario planning for timelines and costs
- Ensure the Trial Master File meets inspection-readiness requirements
- Provide and review study dashboards with cross-functional teams
- Contribute to department initiatives, SOPs, and process development
Requirements
What you’ll need- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 8 years of progressive experience leading global pivotal clinical trials within biotech, pharmaceutical, CRO industry or equivalent clinical research experience
- Experience managing and providing oversight to CROs and vendors, ensuring delivery on time, with quality and within budget
- Experience providing oversight review of PSVs, SIVs, IMVs, and COVs
- Strong knowledge of ICH-GCP guidelines and regulations
- Strong knowledge of the drug development process
- Proficiency in Microsoft Word, Excel, Outlook, PowerPoint, and MS Project
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively in a fast-paced start-up environment with internal and external team members
- Analytical thinking, excellent problem-solving skills, and ability to adapt to changing priorities and deadlines
- Excellent planning, organization, and time management skills, including ability to support and prioritize multiple projects
- Pediatric rare disease and neurology clinical study experience highly desirable
- Rare disease and pediatric experience preferable, but not required
- Dose-escalating/dose-finding study experience including Safety Monitoring Committee experience ideally preferred
Benefits
Comp & perks- Flexible work arrangements balancing individual needs and business needs
- Remote work with approximately 1 day per week on site and flexibility to work in the office when needed
- Employee-led Diversity, Inclusion, and Belonging (DIB) Committee
- Approximately 15% travel opportunity/coverage
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ManagementRisk Identification and MitigationStudy Protocol DevelopmentData Review and ReconciliationOperational Planning
Soft Skills
Excellent Communication SkillsAnalytical ThinkingProblem-Solving SkillsPlanning and OrganizationCollaboration
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft OutlookMicrosoft PowerPointMS Project
Industry Keywords
Clinical Development PlanTrial Master FilePediatric Clinical StudiesDose-Escalating StudiesSafety Monitoring Committee