Director, Trial Master File (TMF) Operations

Job Type: Full-time

Salary: $200K-$215K

Location: Hybrid - San Francisco Bay Area, CA / Jersey City, NJ / NY, NY

Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.

The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.

Responsibilities:

• Leading the TMF Operations function to support Clinical Research and Development
• Managing and overseeing the TMF Operations team, including hiring, training, and performance management
• Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
• Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
• Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
• Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
• Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
• Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders

An ideal candidate for this role MUST have…

• Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
• Proven leadership experience in an insourced biotech organization
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
• Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms

Benefits:

• Pre-IPO biotech company
• Competitive salary with comprehensive benefits (100% medical coverage)
• 401K contribution