Senior Director / Director Clinical Development, Oncology
About The Position
As a (Senior) Director of Clinical Development at BioNTech, you will collaborate closely with the VP of Clinical Development to drive innovative strategies for assigned programs. In this pivotal role, you will oversee the design and execution of clinical trials across all phases, ensuring data integrity, patient safety, and regulatory approval. Leveraging your deep expertise in Immuno-Oncology and Oncology, you will lead matrix teams to deliver impactful results while guiding decisions with scientific rigor and medical insight. Join us to shape the future of medicine through cutting-edge research and development.
Requirements
- 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 (e.g., EMA, FDA), with successful registration being advantageous.
- 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.
Responsibilities
- 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.
Benefits
- Competitive remuneration packages
- Annual bonus
- Equity
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
