Associate Director Trial Master File

BioNTech • Gaithersburg, MD

2d

About The Position

As Associate Director Trial Master File (TMF), you will lead TMF compliance, quality strategies, and operational excellence across BioNTech-sponsored clinical trials, ensuring inspection readiness, regulatory compliance, and successful TMF archiving at trial completion.

Requirements

• University degree or comparable professional education, preferably in medicine, life sciences, paramedical sciences, information management, or business administration. Alternatively, more than 8 years of relevant experience in a regulated clinical development environment with demonstrable expertise in TMF strategy and oversight
• Minimum of 8 years in the pharmaceutical industry or clinical development roles, with at least 5 years of TMF-focused responsibilities
• Broad experience across TMF lifecycle management (start-up, maintenance, closeout, archiving) and a solid understanding of clinical trial processes
• Proven ability to lead TMF initiatives across cross-functional, global teams and provide strategic oversight of TMF operations
• Demonstrated leadership in preparing for and participating in TMF audits and inspections, including health authority interactions
• Experience working with and overseeing TMF vendors and CROs to ensure compliance and performance
• Expert-level knowledge of TMF management frameworks, including TMF Reference Model, ALCOA+ principles, Good Documentation Practices (GDP), and ICH-GCP (E6), as well as familiarity with applicable regulatory frameworks such as 21 CFR Part 11
• Proven ability to serve as a Subject Matter Expert (SME) in TMF systems, ideally including extensive experience with Veeva Vault eTMF
• Experience with TMF governance, metrics, inspection readiness, and continuous process improvement
• Demonstrated ability to develop and maintain TMF-related SOPs, training programs, and cross-functional procedural alignment
• Strong analytical and decision-making skills, capable of interpreting TMF data and identifying trends and risks
• Excellent written and verbal communication skills, with the ability to influence, negotiate, and build partnerships at all levels across internal and external stakeholders
• High level of accountability, attention to detail, and the ability to operate with independence in a high-paced, matrixed environment
• Proficiency in Microsoft Office and other clinical systems, with ability to quickly adapt to new tools and platforms

Responsibilities

• Provide strategic oversight and direction for TMF operations and governance across all phases of clinical trials
• Serve as the TMF SME and strategic advisor to internal and external (CRO) teams and leadership on TMF-related topics, including compliance risks, system enhancements, and regulatory expectations
• Define and maintain TMF health standards across studies by implementing and overseeing key performance indicators (KPIs), metrics, and dashboards
• Lead TMF inspection readiness efforts, ensuring continuous audit preparedness and supporting global inspections by health authorities and internal QA
• Act as the primary TMF representative during audits and inspections, ensuring appropriate documentation access and participation in TMF-related interviews
• Collaborate closely with functions contributing to the TMF (e.g. Clinical Operations, Quality Assurance, Regulatory Affairs, etc.) to ensure TMF integrity and consistent documentation practices
• Manage TMF vendor relationships and CRO oversight, including contract alignment, performance monitoring, and issue resolution
• Drive TMF training and knowledge management across the organization, ensuring that processes, roles, and systems are clearly understood and effectively implemented.
• Lead the development, revision, and alignment of TMF SOPs, work instructions, and process documentation to reflect industry best practices and evolving regulatory expectations
• Provide leadership in eTMF system optimization, acting as a business lead or key user for system upgrades, configuration, and process integration
• Identify and address systemic issues impacting TMF quality, completeness, or timeliness, and proactively implement corrective and preventive actions
• Engage in or lead cross-functional initiatives and process improvement projects aimed at enhancing TMF effectiveness, scalability, and usability
• Ensure TMF completeness at study closeout and readiness for long-term archiving, including oversight of electronic and physical document retention activities
• Mentor and develop TMF team members, sharing knowledge and fostering a high-performance culture focused on quality and accountability

Benefits

• BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
• We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees