Director, Medical Safety & Pharmacovigilance, Safety Strategy Lead

BioNTech SE

Safety Strategy Lead overseeing medical safety governance and leading safety physician teams at BioNTech. Driving safety strategy development for innovative therapeutic products with focus on local China requirements.

Posted 7/9/2026full-timeShanghai • 🇨🇳 ChinaSeniorWebsite

About the role

Key responsibilities & impact

The Safety Strategy Lead China represents a pivotal function in the BioNTech Safety Governance
Leads a team of safety physicians
Ensures balancing of resources and assignment of projects across the safety physicians in his/her team
Provides guidance and personal development for team members
Oversees safety management team(s), responsible for the safety monitoring, benefit-risk assessments and risk management of the assigned products in development and/or marketed
Ensures that single case reporting, signal management and risk management activities which occur under his/her direction and competence, are performed at all times in compliance with applicable law, global and local regulations and in high quality
Is accountable for the quality and timeliness of the medical safety review of and contributions to clinical and regulatory documents concerning the portfolio products
Is medical safety subject matter expert for the assigned products and is the arbiter for safety related issues as they may arise
Responsible for formulating and driving the optimal development safety strategy for the products or product combinations in clinical development at the portfolio level
Assumes accountability for the expert support to independent data and safety monitoring board(s)
Directs safety management team(s) in formulating and maintaining a structured benefit risk assessment for each of the products in development
May decide in consultation with the Head of Medical Safety that an emergent safety issue/product alert deserves escalation to the Executive Safety Council for arbitration and/or action
Contributes and/or oversees delegated contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings globally with focus also on local China requirements
Represents MSPv in joint oversight committees concerning collaborative programs with development partners
Upon request, may support business support in due diligence activities regarding review of assets of interest or asset investments/divestments
Assumes accountability for the planning and implementation of inspection readiness

Requirements

What you’ll need

Medical Degree
In addition, a PhD and/or clinical specialization such as internal medicine, clinical oncology, infectiology is preferred
At least 8 years of experience in the innovative pharmaceutical industry
At least 3 years of medical safety leadership experience in the development of advanced therapeutic medicinal products and/or cellular therapy and/or immuno-oncology products with focus on local China requirements with profound in experience in the global environment; or equivalent in vaccine development.
Experience in the safety requirements for products in the postmarketing setting
Demonstrable experience in creating and implementing a safety strategy for development program of innovative oncology products; or equivalent in infectious disease/vaccination programs in both the translational safety and early clinical development phase and late stage development and filing activities with focus on China requirements
Significant experience in contributing to preparation of interactions with Regulatory Agencies including document drafting and participation in meetings with CDE and other Health Authorities on safety topics
Experience in overseeing, training and line management of medical safety staff
Have achieved demonstrable results with a multidisciplinary team in a matrix organization
Above-average communication skills: able to express complex analyses in concise, clear language; finds persuasive arguments; and an excellent command of the English language.
Competent in analyzing safety data from clinical programs in all phases of clinical development and postmarketing setting; to comprehend and analyze complex data
Deploys good clinical judgement in detecting and assessment of potential safety signals and/or risks
Identifies strategic and tactical opportunities to accelerate achievement of development targets
Can work on solutions for multiple perspectives; pursues questions efficiently and thereby brings issues to their most accurate conclusion
Holds him/herself accountable for achieving high ethical standards in work and behaviours.

Benefits

Comp & perks

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.

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Hard Skills & Tools

Safety Strategy DevelopmentBenefit-Risk AssessmentSignal ManagementSafety Data AnalysisClinical Safety ReviewRegulatory Document DraftingPostmarketing Safety RequirementsTraining and Line ManagementMultidisciplinary Team CollaborationInspection Readiness Planning

Soft Skills

Above-Average Communication SkillsGood Clinical JudgementAccountability for Ethical StandardsPersuasive ArgumentationProblem-Solving