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)