Executive Director, Clinical Development

Role Summary

Location:

Cambridge, US;
Gaithersburg, US;
New Jersey, US. As Executive Director Clinical Development, you will lead the strategic direction and operationalization of clinical development for assigned programs, guiding trials from early to late-stage development through regulatory approval. You will collaborate with multidisciplinary teams globally to drive innovation, ensure patient safety, and uphold data integrity.

• 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 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.

• Experience:
  
  Minimum of 8+ years of relevant clinical R&D experience within Immuno-Oncology, Oncology, and/or Infectious Diseases at biotech/pharmaceutical and academic settings at an international level, including leading development programs from exploratory Phase I/II through Phase III and NDA submission.
• Thorough understanding of clinical and scientific methods and approaches used in clinical development, including novel study designs, application of companion diagnostics for patient selection, clinical pharmacology/translational modeling, and biostatistics; plus experience with confirmatory Phase III trial design and dossier submission.
• Global health authority interactions (EMA, FDA, CDE). Participation or leadership in a drug development program that achieved successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy data and ensuring appropriate contact for study medical and patient safety aspects.
• Demonstrated leadership as a program lead with several years (greater than
  4) of line management experience in a 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).

• Medical Doctor (MD) with a strong scientific background in Immuno-Oncology, Oncology, or Infectious Diseases.