Job Title:
Director, Trial Master File (TMF) Operations
Employer:
EPM Scientific
Location:
Millbrae, CA, USA (San Francisco Bay Area)
Employment Type:
Full-Time
Compensation:
$200,000 to $215,000 per year
Benefits Offered:
Medical (100% medical coverage)
Retirement (401K contribution)
Additional comprehensive benefits
Company Summary
EPM Scientific is a pre-IPO clinical-stage biotech company developing therapies to treat cancer and autoimmune diseases. The company is backed by venture capital and has raised nearly $1 billion to continue advancing its clinical programs.
Position Overview
The Director, TMF Operations will lead the TMF operations function across all clinical trials within the organization. This strategic role requires strong communication and collaboration skills to drive change, ensuring that Trial Master Files (TMFs) are complete, accurate, and compliant with regulatory requirements.
Key Responsibilities
TMF Operations Leadership:
Oversee the TMF Operations function to support Clinical Research and Development.
Lead, hire, train, and manage the TMF Operations team.
Vendor and Stakeholder Management:
Maintain strong relationships with third-party TMF vendors.
Drive issue resolution and remediation activities.
Build and maintain relationships with internal stakeholders and serve as the subject matter expert on TMF requirements.
Process Development and Compliance:
Develop and implement TMF processes, procedures, and training materials that adhere to regulatory standards and industry best practices.
Ensure quality control of TMF documents from study start-up through inspection readiness and archival.
Collaborate with cross-functional teams to maintain TMF completeness and accuracy.
Performance Monitoring:
Develop and establish global TMF Key Performance Indicators (KPIs) for internal staff, CROs, and other stakeholders.
Ideal Candidate Qualifications
Experience & Education:
Minimum of 12+ years of relevant experience with a Bachelor’s degree, or 10+ years with a postgraduate degree.
Proven leadership experience within an insourced biotech organization.
Technical & Regulatory Knowledge:
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations.
Experience with electronic TMF systems (e.g., Veeva) and related technology platforms.
Why Work Here?
Competitive Compensation:
Strong salary range of $200,000 to $215,000 per year.
Growth Opportunities:
A stable pre-IPO biotech environment offering excellent growth opportunities.
Robust Benefits:
Comprehensive benefits package including 100% medical coverage and retirement contributions.
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