Associate Director, Clinical Operations Study Lead
Dyne Therapeutics
June 27, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Role Summary
The Clinical Operations Study Lead translates clinical strategies into operational plans and executes per clinical development plans (CDPs), ensuring study conduct complies with ICH GCP, local regulations, and company policies/SOPs. Leads one highly complex or multiple medium complexity studies; up to 20% travel (including international). Based in Waltham, MA.
Primary Responsibilities
- Manage study operations from start-up to close-out: timelines, budget, milestones, and compliance with SOPs/guidelines/regulations
- Develop study-level operational strategy and clinical operations plans aligned to program objectives/CDP
- Manage invoices and budget tracking; provide input to forecasting
- Select, oversee, and manage CROs and other vendors; monitor performance to contractual deliverables
- Drive performance, quality, timelines, and partner relationships with CRO/vendors
- Oversee scope, quality, timelines, and budget with internal leads/CRO/vendors
- Lead cross-functional teams and manage study team with the CRO
- Coordinate site engagement and investigator meetings; support patient enrollment strategies
- Conduct proactive data monitoring; evaluate issues, interpret data, and implement solutions/mitigation
- Create and maintain risk assessments/mitigation plans
- Provide clinical operations input to protocol, investigator brochure, regulatory documents, clinical study reports, and related documents
- Perform TMF QC reviews to ensure it is “inspection ready”
- Prepare senior-management reports
- Provide leadership and development to indirect reports
Education/Qualifications
- BS/BA in scientific/health field; advanced degree/business degree desirable
- 8+ years clinical trial management (Phase I–III global); sponsor and/or CRO experience preferred; site/monitoring experience advantageous
- Experience across complex therapeutic areas; neuromuscular/muscle preferred; rare disease and/or pediatric preferred
- Strong drug development process, ICH GCP, clinical trial steps, and US/EU patient privacy law knowledge
- Budgeting/accrual/forecasting knowledge
Skills/Preferred
- Lead teams in a fast-paced matrix environment; prioritize multiple tasks
- Build relationships with KOLs and sites; willing to travel
- Vendor selection/oversight experience
- Collaborate across functions (e.g., Medical Affairs, Commercial)
- Strong problem-solving/judgment; detail-oriented
- Excellent communication
MA Pay Range
$159,000 - $195,000 USD
The Clinical Operations Study Lead translates clinical strategies into operational plans and executes per clinical development plans (CDPs), ensuring study conduct complies with ICH GCP, local regulations, and company policies/SOPs. Leads one highly complex or multiple medium complexity studies; up to 20% travel (including international). Based in Waltham, MA.
Primary Responsibilities
- Manage study operations from start-up to close-out: timelines, budget, milestones, and compliance with SOPs/guidelines/regulations
- Develop study-level operational strategy and clinical operations plans aligned to program objectives/CDP
- Manage invoices and budget tracking; provide input to forecasting
- Select, oversee, and manage CROs and other vendors; monitor performance to contractual deliverables
- Drive performance, quality, timelines, and partner relationships with CRO/vendors
- Oversee scope, quality, timelines, and budget with internal leads/CRO/vendors
- Lead cross-functional teams and manage study team with the CRO
- Coordinate site engagement and investigator meetings; support patient enrollment strategies
- Conduct proactive data monitoring; evaluate issues, interpret data, and implement solutions/mitigation
- Create and maintain risk assessments/mitigation plans
- Provide clinical operations input to protocol, investigator brochure, regulatory documents, clinical study reports, and related documents
- Perform TMF QC reviews to ensure it is “inspection ready”
- Prepare senior-management reports
- Provide leadership and development to indirect reports
Education/Qualifications
- BS/BA in scientific/health field; advanced degree/business degree desirable
- 8+ years clinical trial management (Phase I–III global); sponsor and/or CRO experience preferred; site/monitoring experience advantageous
- Experience across complex therapeutic areas; neuromuscular/muscle preferred; rare disease and/or pediatric preferred
- Strong drug development process, ICH GCP, clinical trial steps, and US/EU patient privacy law knowledge
- Budgeting/accrual/forecasting knowledge
Skills/Preferred
- Lead teams in a fast-paced matrix environment; prioritize multiple tasks
- Build relationships with KOLs and sites; willing to travel
- Vendor selection/oversight experience
- Collaborate across functions (e.g., Medical Affairs, Commercial)
- Strong problem-solving/judgment; detail-oriented
- Excellent communication
MA Pay Range
$159,000 - $195,000 USD