Associate Director Trial Master File

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom   |   full time   |   Job ID: 9973 

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.

Your main responsibilites are:

• 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

What you have to offer:

• 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

Your 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.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.