Join to apply for the Director Safety Physician (m/w/d) role at BioNTech SE

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Join to apply for the Director Safety Physician (m/w/d) role at BioNTech SE

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany; New Jersey, US | full time | Job ID: 8982

The Medical Safety Physician is assigned to one or more study management team(s) in the oncology therapeutic area and together with the assigned Safety Scientist(s) provides Medical Safety Support to the team. Direct responsibilities of the Safety Physician are the input to clinical trial protocol, study site (investigator) training, safety data assessments including adverse events of special interest, assessment of individual serious adverse events, determining the follow up information needed, the safety signal detection and evaluation activities and oversight of compliance with GCP and reporting regulations. The Safety Physician contributes to the periodic safety reports (DSUR), the relevant updates of reference safety information, the Investigator´s Brochure and Clinical Trial Report.

This is an exciting time to assume a strategic role in MSPv and help translate science into survival by shaping the culture of patient safety for the wider BioNTech organization.

Main Responsibilities:

• Accountable for the quality performance of one or more safety management team(s) (SMTs)
• Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle
• Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products
• Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level
• Presents and interacts with Regulatory Authorities on safety matters
• Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator’s brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed
• Participates in due diligence for BioNTech’s Licensing /Acquisition initiatives
• Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects
• Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs
• Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards
• Trains and mentors Safety Physicians and Safety Scientists
  
  

• Medical Degree (or internationally recognized equivalent). A MD/PhD and/or certified training in a relevant medical discipline is a plus.
• Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry that includes the development of innovative drugs, BLA/MAA submissions, and advisory committee experience, preferably in immuno-oncology/inflammation therapeutic area(s)
• Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of US
• Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations
  
  

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare
  
  

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

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