Associate Director TMF

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.