Job Description

Responsibilities:

• Provide technical expertise in the management of both paper and electronic Trial Master Files (TMF), ensuring compliance with ICH/GCP guidelines, regulatory requirements and internal policies
• Support inspection readiness initiatives by maintaining TMF documentation that is audit-ready and aligned with industry standards
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to ensure TMF deliverables are completed accurately and within established timelines
• Partner with Contract Research Organizations (CROs) to oversee TMF-related activities, resolve challenges and ensure alignment with project objectives
• Develop and implement a framework to evaluate the overall health of the TMF, focusing on quality, completeness and timeliness
• Conduct regular reviews and audits of the electronic TMF (eTMF) for all BNT-sponsored clinical trials
• Identify gaps in TMF documentation and collaborate with BNT trial teams to implement corrective actions and achieve compliance goals
• Mentor and develop TMF team members, sharing knowledge and fostering a high-performance culture focused on quality and accountability

Qualifications:

• University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 5 years extensive experience in similar roles with a proven track record
• At least five (5) years of pharmaceutical industry or drug development experience with a minimum of three (3) years TMF experience required, including experience in study start-up, maintenance, and closeout, and performing quality and completeness reviews
• 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

Expected Pay Range: $130,800/year to $201,200/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US location and simply send us your documents using our online form.

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.

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