Plays a vital role in supporting the oncology therapeutic area by providing medical safety expertise to one or more study management teams.
Contributes to clinical trial protocols, training investigators, assessing safety data (e.g., adverse events of special interest and serious adverse events).
Determines necessary follow-up actions, and conducts safety signal detection and evaluation.
Ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements.
Contributes to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports.

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.

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.

Director, Safety Physician

Key skills