Director, Clinical Technology Oversight Lead
About the Role
As Director, Clinical Technology Oversight Lead at BioNTech, you will play a pivotal strategic leadership role in establishing and driving end-to-end governance, oversight and performance management of clinical technology vendors across our global clinical trial portfolio. Your work will ensure clear accountability, inspection readiness, and optimal vendor performance within an increasingly digital and AI-enabled ecosystem. By introducing a centralized governance framework, you will directly contribute to BioNTech’s mission of revolutionizing medicine and advancing science to improve health worldwide.
Contribution
- 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.
A Good Match
- Relevant degree in Vendor Management, Clinical Operations, Business Administration, Program Management or related discipline with 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 and Remuneration
Your benefits and remuneration: Expected Pay Range: $168,100/year to $268,700/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.
BioNTech US
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
More details to be shared.