Director Safety Physician

BioNTech•Munich, BY

28d

About The Position

The Medical Safety Physician (MSP) provides medical safety expertise to one or more study management teams supporting the oncology therapeutic area. Working with assigned Safety Scientists, the MSP helps ensure patient safety throughout clinical trials. The role includes contributing to protocols, training investigators, assessing safety data such as adverse events of special interest and serious adverse events, determining follow-up actions, and conducting safety signal detection and evaluation. It also supports compliance with Good Clinical Practice (GCP) and regulatory reporting requirements and contributes to safety documents including Development Safety Update Reports (DSURs), reference safety information, Investigator Brochures, and Clinical Trial Reports. This position has a strategic role in the Medical Safety Pharmacovigilance (MSPv) department. It is accountable for the quality performance of safety management teams and oversees safety monitoring, signal management, and benefit-risk for assigned products throughout their life cycle. The role formulates safety strategy for oncology programs, handles safety inquiries and concerns, engages with Regulatory Authorities, contributes to clinical and regulatory documents, participates in licensing and acquisition due diligence, and represents MSPv in alliance and collaborative development projects. It also serves as a portfolio-level safety subject matter expert and mentors Safety Physicians and Safety Scientists.

Requirements

Medical degree or internationally recognized equivalent.
Extensive drug safety/pharmacovigilance experience in the biopharmaceutical or biotechnology industry, including development of innovative drugs, BLA/MAA submissions, and advisory committee experience.
Exposure to or direct experience working with Regulatory Agencies on development strategies for innovative oncology products, particularly in the United States.
Demonstrable results in a matrix organization and multidisciplinary team.
Experience implementing GCP standards in clinical trials, particularly safety reporting in compliance with global and local regulations.

Nice To Haves

MD/PhD and/or certified training in a relevant medical discipline.
Experience in immuno-oncology and/or inflammation therapeutic areas.

Responsibilities

Be accountable for the quality performance of one or more safety management teams (SMTs).
Oversee safety monitoring, signal management, and the benefit-risk of assigned products throughout the product life cycle.
Identify and lead the escalation, management, and communication of safety inquiries and concerns for assigned products.
Formulate and drive the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level.
Present to and interact with Regulatory Authorities on safety matters.
Oversee the quality of safety contributions to clinical and regulatory documents, including briefing books for regulatory authority meetings, Investigator Brochures, clinical study report safety conclusion sections, responses to regulatory authority inquiries, and other documents as needed.
Participate in due diligence for BioNTech licensing and acquisition initiatives.
Represent MSPv in alliance management projects, including safety data exchange agreement negotiations, joint oversight committees with development partners, and other collaborative development projects.
Serve as the portfolio-level safety subject matter expert and arbiter for safety-related issues across constituent programs.
Ensure activities comply with applicable law, global and local regulations, and internal and external quality standards.
Train and mentor Safety Physicians and Safety Scientists.