Director, US Medical Information & Medical Review
BioNTech•Berkeley Heights, NJ
•$168,100 - $268,700•Onsite
About The Position
BioNTech is seeking an experienced and visionary Director, US-Medical Information & Medical Review to join our US Medical Affairs team. Reporting to the Head of US-Medical Affairs Operations, this leadership role is instrumental in shaping and executing the strategy for medical review activities while overseeing and integrating medical information functions. As part of BioNTech’s mission to revolutionize healthcare, this position will lead efforts to develop and optimize medical review processes, establish agile workstreams, and build cross-functional collaboration frameworks that ensure high-quality, timely, and compliant medical outputs. This is an opportunity to drive innovation, enhance operational excellence, and contribute to delivering transformative therapies to patients worldwide.
Requirements
- Minimum of 8 years of experience in the pharmaceutical or biotech industry, with at least 5 years in a medical affairs role.
- Advanced scientific or healthcare degree (PharmD, PhD, MD, or equivalent strongly preferred).
- Proven expertise in developing and leading medical review processes and multidisciplinary workstreams.
- Strong knowledge of regulatory and compliance requirements for promotional and scientific communications in the pharmaceutical/biotech industry (e.g., EFPIA, FSA, PhRMA).
- Demonstrated leadership in building, mentoring, and managing matrixed teams.
- Exceptional communication, negotiation, and stakeholder management skills.
Nice To Haves
- Experience with digital content review systems and project management tools is a plus.
Responsibilities
- Serve as the principal expert and strategic leader for medical review processes, ensuring the accurate and compliant evaluation of promotional and non-promotional materials, scientific content, and communications. Establish priorities that align with regulatory requirements, ethical standards, and BioNTech’s commitment to scientific excellence.
- Design, implement, and continuously refine robust medical review frameworks and SOPs. Lead the transformation of legacy systems into streamlined scalable processes that support BioNTech’s innovative pipeline and compliance needs.
- Build and manage agile, cross-functional workstreams to support medical review and information activities. Foster collaboration, remove barriers to efficiency, and drive accountability across stakeholders.
- Inspire, mentor, and empower a high-performing, matrixed team of medical reviewers, information specialists, and project managers. Define clear roles and responsibilities while cultivating a culture of excellence and innovation.
- Act as a strategic partner to Regulatory, Legal, Compliance, Commercial, and Scientific Affairs teams, ensuring seamless communication and alignment on pipeline and marketed product strategies.
- Lead the development and delivery of scientifically accurate, high-quality medical information to healthcare professionals, patients, and internal teams. Champion best-in-class inquiry response, content creation, and knowledge management practices.
- Stay ahead of evolving regulations, guidance, and industry standards. Lead audit readiness and risk mitigation efforts to ensure compliance and operational excellence.
- Drive a culture of adaptability and continuous improvement, guiding teams through process evolution and fostering innovation in medical review and information practices.
- Establish and monitor key performance indicators to measure the impact and effectiveness of medical review and information services. Provide actionable insights and data-driven recommendations to executive leadership.
- Thrive in a fast-paced, evolving environment, managing multiple priorities while maintaining focus on quality and impact.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
