Director, Trial Master File (TMF) Operations
Company: EPM Scientific
Location: Millbrae, CA, USA (San Francisco Bay Area)
Job Type: Full-time
Salary: $200,000 - $215,000 per year
Benefits: Medical, 401K Contribution
Company Summary:
A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune diseases. The company is backed by venture capital and has successfully raised nearly $1 billion to advance its clinical programs.
The Opportunity:
The Director, TMF Operations will lead and manage TMF operations across all clinical trials within the organization. This role involves driving change at a strategic level and ensuring that TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
Leadership & Oversight: Lead the TMF Operations function to support Clinical Research and Development.
Team Management: Manage, hire, train, and oversee the TMF Operations team, ensuring high performance.
Vendor Management: Maintain strong relationships with TMF third-party vendors, drive issue resolution, and oversee remediation activities.
Process Development: Develop and implement TMF processes, procedures, and training materials aligned with regulatory requirements and industry best practices.
Stakeholder Collaboration: Act as a subject matter expert, maintaining strong relationships with internal stakeholders to ensure TMF completeness and accuracy.
Regulatory Compliance: Ensure TMF documents meet GCP and regulatory standards from study start-up through inspection readiness and archival.
KPI Development: Establish and monitor TMF Key Performance Indicators (KPIs) for internal staff, CROs, and other stakeholders.
Requirements:
Experience: Minimum of 12+ years with a Bachelor's degree or 10+ years with a postgraduate degree in relevant fields.
Biotech Leadership: Proven leadership experience in an insourced biotech organization.
Regulatory Knowledge: Strong understanding of ICH-GCP, FDA, EMA, and other regulatory requirements.
eTMF Expertise: Proficiency with electronic Trial Master File systems (e.g., Veeva) and related technology platforms.
Benefits:
Pre-IPO Growth Opportunity: Opportunity to contribute to a rapidly growing biotech company.
Comprehensive Medical Coverage: 100% medical coverage.
401K Contribution: Competitive retirement benefits.
About EPM Scientific:
EPM Scientific is a top 10 pharmaceutical company that experienced significant growth following the release of its at-home COVID diagnostic tests. The company is conducting a large-scale hiring campaign, aiming to onboard over 200 Quality Specialists.
For more information, visit http://www.epmscientific.com
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