Job Title: Director, Trial Master File (TMF) Operations
Location: Millbrae, CA, USA
Salary: $200,000 - $215,000 per year
Job Type: Full-time
Company Overview:
EPM Scientific is a pre-IPO clinical stage biotech company focused on developing therapies for cancer and autoimmune diseases. The company has raised nearly $1 billion in funding and is continuing to advance its clinical programs. EPM Scientific is backed by VCs and offers strong compensation packages, stability, and growth opportunities.
Position Overview:
The Director of TMF Operations will lead TMF operations for all clinical trials across the organization. This individual will drive change at a strategic level, ensuring that Trial Master Files (TMFs) are complete, accurate, and compliant with regulations. The role requires strong communication, collaboration skills, and the ability to manage a team of TMF professionals.
Key Responsibilities:
Leadership and Management:
Lead the TMF Operations function to support Clinical Research and Development.
Manage the TMF Operations team, including hiring, training, and performance management.
Maintain relationships with TMF third-party vendors, driving resolution of issues and remediation activities.
Process and Procedure Development:
Develop and implement TMF processes and procedures that adhere to regulatory requirements and industry best practices.
Create TMF-related training materials and ensure the team is trained accordingly.
Collaboration and Stakeholder Management:
Develop and maintain strong relationships with internal stakeholders, 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.
Quality Control and Regulatory Compliance:
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival.
Establish TMF Key Performance Indicators (KPIs) globally for internal staff, CROs, and other stakeholders.
Qualifications:
Experience:
Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years 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.
Skills:
Strong leadership and team management abilities.
Exceptional communication and collaboration skills.
Expertise in TMF document management and quality control.
Benefits:
Pre-IPO biotech company.
Competitive salary with comprehensive benefits, including 100% medical coverage.
401K contribution.
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