New Jersey, US | full time | Job ID: 11492
About the role:
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.
Your contribution:
- Medical Review Leadership: 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.
- Process Development and Optimization: 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.
- Workstream Management: 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.
- Team Leadership: 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.
- Cross-Functional Collaboration: 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.
- Medical Information Oversight: 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.
- Quality Assurance & Compliance: Stay ahead of evolving regulations, guidance, and industry standards. Lead audit readiness and risk mitigation efforts to ensure compliance and operational excellence.
- Change Management: Drive a culture of adaptability and continuous improvement, guiding teams through process evolution and fostering innovation in medical review and information practices.
- Metrics & Reporting: 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.
- Dynamic Environment: Thrive in a fast-paced, evolving environment, managing multiple priorities while maintaining focus on quality and impact.
A good match:
- 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.
Preferred Qualifications:
- Experience with digital content review systems and project management tools is a plus.
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 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.
Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.
Apply now - We look forward to your application!
Apply for our New Jersey, 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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BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
BioNTech - As unique as you
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