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Director Safety Physician (m/w/d)
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Director Safety Physician (m/w/d)
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BioNTech SEMainz, 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 cycleIdentifies and leads escalation, management, and communication of safety inquiries and concerns for assigned productsFormulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio levelPresents and interacts with Regulatory Authorities on safety mattersOversees 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 neededParticipates in due diligence for BioNTech’s Licensing /Acquisition initiativesRepresents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projectsServes as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programsEnsures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standardsTrains and mentors Safety Physicians and Safety Scientists
What You Have to Offer:
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 USHas 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 Benefits:
It''s our priority to support you:
Your flexibility: flexible hours | vacation accountYour growth: Digital Learning | Performance and talent development | leadership development | Apprenticeships | LinkedIn LearningYour value: Your voice at the table | Culture on an equal footing | Opportunities to shape and impact | Support for your full potentialYour health and lifestyle: Company bikeYour mobility: Job ticket | DeutschlandticketYour life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany; New Jersey, USlocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 8982 (please always specify if you have any questions)
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.Seniority level
Seniority level DirectorEmployment type
Employment type Full-timeJob function
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