TMF Strategy Director | Global Trial Master File Lead

Dyne Therapeutics; Waltham (MA); On-site; USD 155,000 - 190,000; Full time

Job summary

A biotechnology company located in Waltham is seeking an Associate Director, Trial Master File (TMF) Lead. This role involves developing TMF strategies, ensuring compliance with regulatory requirements, and overseeing documentation quality. The ideal candidate will possess over 8 years of experience in clinical operations and TMF expertise, strong communication skills, and the ability to lead cross-functional teams. The position offers a salary range of $155,000 - $190,000 USD, reflecting experience and qualifications.

Qualifications

• 8+ years of experience in clinical operations or related GxP environment.
• Significant TMF expertise required.
• Strong knowledge of ICH GCP and regulatory expectations.

Responsibilities

• Develop and drive the global TMF strategy.
• Ensure TMF operations meet regulatory requirements.
• Monitor adherence to processes and manage TMF quality issues.

Skills

Clinical operations

Document management

Regulatory compliance

Leadership without authority

Stakeholder management

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Tools

eTMF systems

Job description

A biotechnology company located in Waltham is seeking an Associate Director, Trial Master File (TMF) Lead. This role involves developing TMF strategies, ensuring compliance with regulatory requirements, and overseeing documentation quality. The ideal candidate will possess over 8 years of experience in clinical operations and TMF expertise, strong communication skills, and the ability to lead cross-functional teams. The position offers a salary range of $155,000 - $190,000 USD, reflecting experience and qualifications.