Director, Trial Master File

Position Overview

As we advance deupirfenidone (LYT-100) through Phase 3 toward registration, Celea is seeking an experienced, strategic, and hands-on Director, Trial Master File (TMF) to establish and maintain the standards, processes, systems, and oversight framework necessary to ensure TMFs are complete, accurate, timely, inspection-ready, and compliant with applicable regulatory requirements, ICH-GCP, organizational procedures, and industry best practices. This role provides oversight of TMF activities across the clinical development portfolio, including internal teams, CROs, functional service providers, and other external partners. The Director proactively identifies TMF risks and trends, establishes appropriate governance and escalation mechanisms, and partners with functional leadership to drive accountability and sustainable improvements in TMF quality.

In the near term, your focus will be supporting Phase 3 clinical studies focusing on inspection readiness, TMF quality, and operational execution by strengthening oversight through quality reviews, risk-based monitoring, and cross-functional collaboration, while optimizing eTMF processes, enhancing vendor performance, resolving quality findings and CAPAs, and ensuring timely document management, reconciliation, and study milestone readiness, making you instrumental in guiding Celea through its next chapter.

This position is open to onsite or remote work.

Key Responsibilities

• Provide strategic leadership for the TMF program, establishing governance, standards, processes, and oversight to ensure consistent execution across the clinical development portfolio.
• Serve as the TMF subject matter expert, driving compliance with regulatory requirements, industry best practices, and risk-based quality management through close partnership with Clinical Operations and Quality Assurance leadership.
• Provide TMF oversight throughout the clinical trial lifecycle, from study start-up through closeout and archival.
• Monitor TMF quality metrics, risks, and compliance trends, driving escalation, remediation, and continuous improvement.
• Lead TMF inspection and audit readiness, supporting regulatory inspections, audits, and quality assessments.
• Oversee resolution of TMF findings through CAPAs, effectiveness monitoring, and process enhancements.
• Establish and manage TMF expectations for CROs, vendors, and external partners, including performance and risk oversight.
• Provide leadership for eTMF systems, TMF processes, and team development to ensure operational excellence and organizational capability.

Qualifications

Required

• Bachelor’s degree in life sciences or a related scientific discipline; an advanced degree (MS, MBA, MPH, PhD, PharmD) is preferred; equivalent experience considered.
• 10+ years of experience in clinical research, TMF management, Clinical Operations, or Development Operations.
• 5+ years of leadership experience managing TMF teams or document management functions.
• Experience supporting global clinical trials across multiple phases.
• Demonstrated experience with regulatory inspections and audit readiness programs.
• Experience managing CROs, vendors, and outsourced TMF activities.
• Deep knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Strong understanding of the TMF Reference Model and TMF lifecycle management.
• Expertise in eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan, Florence).
• Knowledge of risk-based quality management and inspection readiness practices.
• Experience developing TMF governance frameworks, processes, metrics, and compliance programs.
• Strategic leadership and organizational influence.
• Strong people management, coaching, and talent development skills.
• Ability to lead cross-functional teams and drive change.
• Excellent stakeholder management and communication skills.
• Strong problem-solving, decision-making, and risk management capabilities.

Preferred

• Experience leading TMF programs across a large clinical development portfolio.
• Successful track record supporting major regulatory inspections (FDA, EMA, MHRA, PMDA).
• Experience implementing or optimizing eTMF systems and TMF operational processes.
• Relevant certifications such as ACRP, SOCRA, PMP, or TMF-specific training/certifications.

Why Join Celea Therapeutics

• Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
• Shape the foundation of a Phase 3 biotech poised for significant growth.
• Collaborate with a passionate, mission-driven leadership team.
• Competitive compensation and equity package.

Compensation

Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $215,000-$245,000 plus bonus and equity. Where an offer lands within the range reflects the candidate’s experience, skills, and internal equity — and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.

Our Commitment

Celea Therapeutics is an equal opportunity employer. We evaluate every candidate against the requirements of the role using a structured, evidence-based process, and we make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.

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