Job Type: Full-time Salary: $200K-$215K Location: Hybrid - San Francisco Bay Area, CA / Jersey City, NJ / NY, NY

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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