BioNTech is hiring a Director of Clinical Development to collaborate closely with the VP of Clinical Development in a mission-driven environment focused on innovation. You will drive strategic planning and operational execution for assigned clinical programs, overseeing trials from design through regulatory submission.
What You'll Do
- Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval.
- Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions.
- Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes.
- Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries.
- Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes.
- Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports.
- Build strong relationships with external stakeholders while representing the team in governance meetings.
What We're Looking For
- M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology.
- Extensive experience leading clinical development programs across Phases I–III, including NDA submissions.
- Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
- Proven experience interacting globally with health authorities such as the EMA and FDA.
- Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes.
- Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles.
Nice to Have
- Successful registration with health authorities.
Team & Environment
You will collaborate closely with the VP of Clinical Development and serve as Program Lead, guiding core teams. You will report directly to the VP of Clinical Development within BioNTech's collaborative, mission-driven culture.
Work Mode
This role is based locally in Mainz, Germany, London, United Kingdom, or Munich, Germany.
BioNTech is an equal opportunity employer.
