Senior Director - Head of Trial Master File

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Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• We are seeking a Senior Director of TMF to serve as the Head of Trial Master File (TMF) Operations. • This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of a TMF document management system for the clinical operations department. • This position is responsible for cross-functional collaboration to ensure proper implementation, execution and alignment with companies’ goals, culture, and vision. • This role is accountable to develop document collection strategies and develop SOPs, training, and overall process to ensure the TMF health and archival of clinical trial documents from both external and internal sources. • The position is responsible for direct reports to manage the TMF and continue to work with IT in the evaluation, and implementation of any additional technology and vendors to support documentation and training solutions for inspection readiness.

Requirements

• Bachelor's Degree or higher • 15+ years' experience leading successfully the TMF activities for clinical research/ biotech/pharmaceutical • Leadership skills and experience managing employees and contractors • Experience with Veeva eTMF platform, strongly preferred • Experience with Trial Master File Reference model and good understanding of records management best practices • Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA • Experience with Inspection readiness • Hands on experience in a regulatory body inspection, strongly preferred • Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • Flexible PTO • Two, one-week company-wide shutdowns each year • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve