Director Medical Safety & Pharmacovigilence, Safety Strategy Lead

Shanghai, China   |   full time   |   Job ID: 10561 

Position Summary:

The Safety Strategy Lead China represents a pivotal function in the BioNTech Safety Governance; therefore, the SSL assumes accountability for:

• an optimal performance of the cross-functional safety management team(s) under his/her leadership in the local as well as global setting with active contribution when needed
• formulating and driving the development safety strategy for the programs under his/her leadership
• the detection, evaluation and decision-making on safety observations as well as the assessment of the Benefit/Risk balance; with escalation of emerging safety risks where appropriate to the Head of Medical Safety and/or Head of MSPv and the Executive Safety Council

Your main responsibilities are:

• The Safety Strategy Lead China
  •    leads a team of safety physicians
  o    Ensures balancing of resources and assignment of projects across the safety physicians in his/her team
  o    Provides guidance and personal development for team members
  o    Can delegate the below mentioned tasks to team members, in his/her own responsibility, based on judgement of the individual capabilities and training needs of team members.
  •    oversees (or leads) the safety management team(s), responsible for the safety monitoring, benefit-risk assessments and risk management of the assigned products in development and/or marketed;  
  o    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;
  o    is responsible that the safety management team(s) maintain(s) a core safety information for each of the products in development that is up-to-date;
  o    is accountable for the quality and timeliness of the medical safety review of and contributions to clinical and regulatory documents concerning the portfolio products;
  o    is medical safety subject matter expert for the assigned products (in development or post-authorization) and is the arbiter for safety related issues as they may arise;
  •    is responsible for formulating and driving the optimal development safety strategy for the products or product combinations in clinical development at the portfolio level;
  o    is responsible that a regular benefit-risk assessment of the assigned products (in development or post-authorization) is conducted
  o    where applicable, assumes accountability for the expert support to independent data and safety monitoring board(s) 
  o    directs (or leads) the 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, clinical study report safety conclusion section, responses to key regulatory authority inquiries on products in development and the authoring of safety components of other regulatory documents such as Clinical Trial (IND) and/or Marketing Authorization Applications (MAA/NDA/BLA);
  o    where applicable, presents at regulatory authority meetings;
  •    represents MSPv in joint oversight committees concerning collaborative programs with development partners;  
  o    represents or may delegate representation of medical safety in joint safety management teams with development partners;
  o    represents Medical Safety interests in alliance management projects such as safety data exchange agreement negotiations and their updates;
  o    participates or may delegate participation in other collaborative development projects, as they may occur;
  •    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; 
  o    may represent or delegate representation of Medical Safety in case of an audit or regulatory inspection; 
  o    contributes to and is accountable for the timely and competent implementation of any agreed corrective actions following from audits or inspections;   
  •    assumes accountability for appropriate assistance to disaster recovery planning and the implementation of business continuity measures where this concerns the activities of the safety management team  
  •    ensures that a written delegation of authority is in place in case of his/her absence  
  •    may substitute for the Head of Medical Safety, following a written delegation; 
  •    is responsible for all other matters in his/her competence, as assigned to him/her on occasion by the Head of Medical Safety.

What you have to offer:

• 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, of which 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

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.