Director Safety Physician

About the role

The Medical Safety Physician (MSP) plays a vital role in supporting the oncology therapeutic area by providing medical safety expertise to one or more study management teams. In collaboration with assigned Safety Scientists, the MSP ensures patient safety throughout the clinical trial process. Responsibilities include contributing to clinical trial protocols, training investigators, assessing safety data (e.g., adverse events of special interest and serious adverse events), determining necessary follow-up actions, and conducting safety signal detection and evaluation. The MSP also ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements, while contributing to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports. This position offers the opportunity to take on a strategic role within the Medical Safety Pharmacovigilance (MSPv) department.

Your Contribution

• 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

A good match

• 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