Associate Director TMF

$165k - $200k

GQR

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.

Apply

Vacancy posted 3 days ago

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