Job Description
About the Company
A Clinical-Stage Biotech advancing a cardiometabolic pipeline toward pivotal trials is hiring its Associate Director, Trial Master File.
About the Role
You will own TMF strategy, governance, and inspection readiness across the portfolio - the sponsor voice for every CRO, and the person leadership trusts when an inspector asks for the file. This is a build, not a cleanup. You set the TMF Reference Model mapping, the KPIs, and the inspection playbook the company carries from Phase I through IV.
Responsibilities
- TMF strategy, governance, and health across Phase I-IV studies
- Inspection readiness and audit support as the TMF subject matter expert
- Sponsor oversight of CRO and vendor TMF activities, including the monthly CRO TMF review
- eTMF completeness, quality, and timely filing - SOPs, CAPAs, risk-based oversight
- Partnership across Clinical Operations, Quality, Regulatory, and IT
Qualifications
- 8+ years in clinical research (biotech or pharma) with a TMF career built from the ground up
Required Skills
- Deep eTMF expertise - Veeva Vault, Trial Interactive, or Wingspan
- Command of ICH GCP (E6 R2/R3) and the TMF Reference Model
- A track record supporting FDA or EMA inspections as the TMF expert
Pay range and compensation package
Base $165,000-$200,000, plus bonus and equity. Full benefits, 401k match, unlimited PTO.
Equal Opportunity Statement
Confidential search. Apply through this posting.