Job Title

Job ***** Full-time ***** $200K-$215K***** Hybrid - San Francisco Bay Area, CA / Jersey City, NJ / NY, NYCompany ***** 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 ***** 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.**Leading the TMF Operations function to support Clinical Research and DevelopmentManaging and overseeing the TMF Operations team, including hiring, training, and performance managementMaintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activitiesDevelop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practicesDevelop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirementsCollaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycleManage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archivalDevelop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholdersAn ideal candidate for this role MUST have...Minimum of 12+ years of experience with a Bachelors degree, or 10+ years of experience with a post graduate degreeProven leadership experience in an insourced biotech organizationStrong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operationsExperience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms**Pre-IPO biotech companyCompetitive salary with comprehensive benefits (100% medical coverage)401K contribution