Associate Director, Trial Master File Lead
Dyne Therapeutics
June 27, 2026
Remote friendly (Waltham, MA)
United States
$155,000 - $190,000 USD yearly
Clinical Research and Development
Role Summary
The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end-to-end oversight of the Trial Master File across the clinical portfolio.
Primary Responsibilities Include
- TMF Strategy & Leadership: define and own TMF strategy; lead scalable TMF operating models; serve as internal SME on TMF best practices/regulations/inspection trends; represent TMF leadership in cross-functional forums.
- Governance & Process Ownership: establish/maintain TMF governance (policies, SOPs, work instructions, quality standards); oversee TMF lifecycle (planning/setup through closeout/archival); define TMF roles/responsibilities and RACI across teams/vendors; monitor adherence and drive CAPAs; ensure timely TMF document collection/review/management.
- TMF Oversight & Compliance: provide strategic oversight (quality reviews, completeness assessments, KPIs); ensure TMFs are inspection ready; lead TMF preparation for audits/inspections/regulatory submissions; analyze TMF metrics/trends to identify risks/gaps.
- Vendor & Technology Management: oversee TMF service providers/CROs/technology platforms; optimize eTMF system workflows/integrations with IT/business; ensure vendor contractual/performance/quality adherence; stay current on TMF-related industry/regulatory trends.
- Cross Functional Partnership & Support: guide TMF planning/milestones/document management; train/coach partners on TMF processes and regulatory requirements; advise leadership on TMF health/readiness.
Education and Skills Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 8+ years in clinical operations/document management or related GxP environment with significant TMF expertise.
- Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations.
- Proven experience developing TMF strategy/governance/enterprise processes.
- Ability to lead cross-functionally without authority; demonstrated portfolio-level TMF leadership.
- eTMF system and CRO/vendor oversight experience.
- Excellent communication, influencing, and stakeholder management.
Pay Range
$155,000 - $190,000 USD
The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end-to-end oversight of the Trial Master File across the clinical portfolio.
Primary Responsibilities Include
- TMF Strategy & Leadership: define and own TMF strategy; lead scalable TMF operating models; serve as internal SME on TMF best practices/regulations/inspection trends; represent TMF leadership in cross-functional forums.
- Governance & Process Ownership: establish/maintain TMF governance (policies, SOPs, work instructions, quality standards); oversee TMF lifecycle (planning/setup through closeout/archival); define TMF roles/responsibilities and RACI across teams/vendors; monitor adherence and drive CAPAs; ensure timely TMF document collection/review/management.
- TMF Oversight & Compliance: provide strategic oversight (quality reviews, completeness assessments, KPIs); ensure TMFs are inspection ready; lead TMF preparation for audits/inspections/regulatory submissions; analyze TMF metrics/trends to identify risks/gaps.
- Vendor & Technology Management: oversee TMF service providers/CROs/technology platforms; optimize eTMF system workflows/integrations with IT/business; ensure vendor contractual/performance/quality adherence; stay current on TMF-related industry/regulatory trends.
- Cross Functional Partnership & Support: guide TMF planning/milestones/document management; train/coach partners on TMF processes and regulatory requirements; advise leadership on TMF health/readiness.
Education and Skills Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 8+ years in clinical operations/document management or related GxP environment with significant TMF expertise.
- Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations.
- Proven experience developing TMF strategy/governance/enterprise processes.
- Ability to lead cross-functionally without authority; demonstrated portfolio-level TMF leadership.
- eTMF system and CRO/vendor oversight experience.
- Excellent communication, influencing, and stakeholder management.
Pay Range
$155,000 - $190,000 USD