Director, Clinical Technology Oversight Lead

BioNTech SE

Director, Clinical Technology Oversight Lead at BioNTech driving clinical technology governance and vendor performance management. Collaborating across departments to enhance trial delivery reliability and compliance.

Posted 7/10/2026full-timeCambridge • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $168,100 - $268,700 per yearWebsite

Tech Stack

Tools & technologies

CloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Design and implement a global Clinical Technology Vendor Governance Framework aligned with ICH GCP E6 R3 and regulatory standards.
Oversee day-to-day vendor performance for technologies like EDC, eCOA, RTSM, eTMF, RBM, digital health solutions, and AI-driven systems.
Define KPIs, SLAs, and metrics tied to study timelines, data quality, system performance, and delivery reliability.
Establish robust AI governance frameworks ensuring transparency in intended use, decision boundaries, risk classification, validation processes, and lifecycle management.
Proactively manage risks through monitoring systems while maintaining inspection readiness for regulatory audits.
Serve as the central escalation point for issue resolution across internal teams and external vendors.
Drive strategic oversight of technology vendors to optimize scalability and cost-efficiency while fostering trust-based partnerships.

Requirements

What you’ll need

Relevant degree in Vendor Management, Clinical Operations, Business Administration, Program Management or related discipline
12 years of clinical technology management experience with expertise in clinical trial technologies (EDC/eCOA/RTSM/eTMF/RBM/digital health) and AI/ML applications in trials
Strong understanding of system architectures (APIs/data flows), cloud-based platforms (SaaS models), AI/ML fundamentals (bias/drift/validation), vendor oversight (SLAs/performance), and computerized system validation expectations
Proven ability to translate complexity into clear governance structures while managing interdependencies across systems/processes
Exceptional interpersonal skills with experience influencing stakeholders in matrix environments
Fluency in English is required; German is advantageous.
Resilience in overcoming challenges coupled with agility to adapt to dynamic circumstances.

Benefits

Comp & perks

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!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Trial TechnologiesEDCECOARTSMETMFRBMAI/ML FundamentalsSystem ArchitectureCloud-Based PlatformsComputerized System Validation

Soft Skills

Interpersonal SkillsResilienceAgility