Job Description

Mainz, Germany; London, United Kingdom | full time | Job ID: 9419





Reporting to the Executive Director, Medical Excellence, the Medical Governance & Operations Lead is accountable for establishing, maintaining, and continuously improving the global framework that underpins compliant, efficient, and patient-focused Medical Affairs activities. By integrating governance, risk management, and operational excellence, this role safeguards the organization while enabling timely delivery of scientific and medical initiatives. The position partners closely with Medical Affairs leadership, Clinical Development, Regulatory, Pharmacovigilance, Compliance, Legal and Commercial functions to ensure that global medical processes--ranging from Medical-Legal-Regulatory (MLR) review to Post-Authorization (Phase IV) research--meet or exceed internal and external standards.

Key Responsibilities

Governance, Policy & Risk Management


Review, harmonize, and update global Medical Affairs policies, SOPs, and work instructions in line with evolving regulations (e.g., FDA, EMA, ICH), industry codes (EFPIA, PhRMA), and company standards. Conduct regular risk assessments across all GMA processes; develop and implement mitigation plans, monitoring metrics, and corrective actions. Serve as primary Medical Affairs liaison with Compliance and Quality teams to ensure alignment of governance frameworks company-wide. Champion a culture of integrity and transparency through ongoing communication, onboarding, and refresher training programs.




Audit & Inspection Readiness


Establish an audit-ready mindset by embedding quality controls and documentation standards in day-to-day medical activities. Lead Global pre-audit self-inspections, manage CAPAs, and oversee follow-up actions to close findings in a timely manner. Act as Medical Affairs subject matter expert during Health Authority inspections and internal audits.




Operational Excellence & Process Optimization


Drive strategic initiatives to streamline Medical Affairs operations, including workflow redesign, automation, and digital tool integration to enhance efficiency and reduce cycle times. Develop and monitor KPIs and operational dashboards to track performance, identify bottlenecks, and enable data-driven decision making. Facilitate cross-functional governance forums to prioritize and resource critical medical projects.




Phase IV / Post-Authorization Research Oversight


Oversee end-to-end planning, execution, and tracking of Phase IV and observational studies, ensuring scientific rigor, budget adherence, and timely dissemination of results. Ensure studies comply with Good Clinical Practice (GCP), applicable regulations, and internal governance requirements. Partner with Clinical Operations, Biostatistics, and HEOR to maximize study impact on medical strategy and patient outcomes.




Medical Review & Approval Processes


Serve as global business owner for the MLR (Medical-Legal-Regulatory) review process Define standards for content quality, review timelines, and documentation; monitor adherence and drive continuous improvement.




Collaborative Research Studies (CRS), Investigator-Initiated Trials (IITs) & Compassionate Use


Own governance and operational frameworks for CRS/IIT evaluation, approval, budgeting, contracting, and data dissemination. Establish and manage the compassionate use / expanded access program, ensuring ethical, regulatory-compliant, and timely patient access to investigational products. Track program metrics and report to senior leadership and regulatory bodies as required.




Compliance & Training


Develop and deliver training modules on governance processes, policy updates, and inspection readiness for Medical Affairs staff and relevant stakeholders. Maintain a global repository of training records and policy acknowledgments.




Team leadership


Lead, mentor and develop a high-performing team of professionals, providing clear guidance on expectations, ongoing support and development opportunities and feedback as needed. Foster a collaborative and inclusive culture focused on continuous learning, innovation, and professional growth. Provide direction and guidance to team members on strategic initiatives, operational processes, best practices, and strategic objectives.

What you have to offer

Education:


Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field. Advanced degree (PharmD, PhD, MD, MPH, or MBA) preferred.




Experience:


+ 10 years in Medical Affairs, Clinical Operations, Quality, or Compliance within the pharmaceutical/biotech industry. Direct experience managing MLR review, IIT/CRS governance, or compassionate use programs. Proven track record of leading or participating in audits/inspections and implementing CAPAs. Demonstrated ability to drive operational efficiency projects in a matrix, global environment.




Preferred Requirements:


Global or multi-regional exposure to regulatory frameworks (FDA, EMA, PMDA, etc.). Experience with digital platforms and data analytics dashboards.




Skills & Competencies:


Governance & Compliance - Deep understanding of regulatory landscapes and industry codes affecting Medical Affairs. Strategic Thinking - Ability to align governance initiatives with broader business objectives and future needs. Project & Program Management - Skilled at planning, prioritizing, and delivering multiple complex projects within budget and timelines. Risk Assessment - Proficient in identifying, quantifying, and mitigating operational and compliance risks. Communication - Exceptional written and verbal skills; able to translate regulations and complex processes into clear, actionable guidance. Leadership & Influence - Builds consensus, leads without formal authority, and fosters a culture of accountability and continuous improvement. Analytical Mindset - Adept at interpreting data, generating insights, and presenting to senior leadership. Problem Solving - Anticipates challenges, applies structured methodologies, and drives timely resolution.




Travel:


Up to 20%, including global and regional meetings, audits, and site visits.




This position is critical to ensuring that our Global Medical Affairs organization operates with the highest standards of governance and operational excellence, ultimately enabling impactful science and improved patient outcomes.

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.




Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.




Please note:


Only applications sent via our online form shall be considered. 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.




We are looking forward receiving your application.

Inspired? Become part of #TeamBioNTech.

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

www.biontech.com