Medical Director

• 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

Director, Medical Safety & Pharmacovigilance, Safety Strategy Lead

• Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products, and in the post marketing period.
• Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.
• Develops new and enhances existing client relationships whenever possible.
• Provides medical/safety expertise to colleagues within PSS, including communicating information regarding safety regulations and any changes that have occurred.
• When applicable, responsible for preparation and medical review of Aggregate Reports (such as Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products.
• Provides safety support/expertise to project physicians, as appropriate.
• Presents Safety capabilities to clients as part of a proposal team, when appropriate.
• When applicable, responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during post marketing surveillance in support of safety activities.
• When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products.
• All other duties as needed or assigned.

Associate Medical Director – Safety Physician

• Participates in development of the CD plan for assigned molecule(s)/indication(s)
• Gathers and analyzes data and information necessary to create the CD plan
• Works with other CST members and relevant sub-teams to develop CD plan components
• Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s)
• Collaborates with a variety of internal and external partners and stakeholders
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance
• Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies, including providing CD input for MA study protocol development
• Participates in design, development, and execution of clinical studies
• Collaborates with others in the development of product safety profiles
• Includes reviewing and providing late stage input into Phase I and II protocols
• Supports other CST members to ensure correct medical/scientific data interpretation for interim and final study reporting
• Acts as a medical monitor for assigned studies
• Participates as standing or ad hoc member of sub-teams relevant to assigned molecule(s)/indication(s)

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Director, Medical Safety & Pharmacovigilance, Safety Strategy Lead

Associate Medical Director – Safety Physician

Medical Director, CVM