Executive Director, Clinical Development
About The Position
As Executive Director Clinical Development, you will be at the forefront of steering clinical strategies and their operationalization for assigned programs. This role directly contributes to BioNTech's mission by leading the strategic direction of platforms and programs, ensuring clinical trials are designed and executed with precision from early to late-stage development through regulatory approval. You will work within a dynamic team environment, collaborating closely with multidisciplinary teams globally to drive innovation, ensure patient safety, and uphold data integrity.
Requirements
- Medical Doctor (MD) with a strong scientific background in Immuno-Oncology, Oncology, or Infectious Diseases.
- Minimum of 8 + years of relevant experience in clinical R&D within Immuno-Oncology, Oncology and/or Infectious diseases at the biotech/pharmaceutical and the academic setting at an international level, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA submission.
- Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
- Experienced in global health authority interactions (EMA, FDA, CDE). Having participated or led a drug development program to successful registration is an advantage.
- Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
- Demonstrated leadership experience as a program lead and several years (> 4 years) line management experience in global matrix organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority.
- Proficiency in English (written and spoken).
Responsibilities
- Lead and manage a team of medical professionals representing Clinical Development within global teams, including Core Teams, Project Teams, and Study Teams.
- Oversee the design and execution of clinical trials, ensuring alignment with BioNTech’s strategic goals and regulatory requirements.
- Supervise the creation of integrated evidence generation plans paving paths toward regulatory approval.
- Represent BioNTech in collaborations with industry partners, academic investigators, advisory meetings with opinion leaders, and interactions with Health Authorities.
- Provide medical expertise across functions such as business development, discovery, non-clinical development, medical communications, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety.
Benefits
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
