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Senior Director, Clinical Science - Oncology

BioNTech SE
Remote friendly (Cambridge, MA)
United States
$260,000 - $330,000 USD yearly
Clinical Research and Development

Role Summary

Director/Senior Director of Clinical Science focused on oncology and immuno-oncology. Lead innovative clinical development strategies, ensure safety and efficacy of investigational drugs, and drive global clinical studies while improving clinical data processes. Collaborate with cross-functional teams to advance trials in a forward-thinking environment.

Responsibilities

  • Design cutting-edge clinical trials in collaboration with Clinical Development Leads to evaluate investigational drugs’ safety and efficacy, including protocols, patient populations, and study endpoints.
  • Ensure medical oversight of clinical trials, monitoring study progress, reviewing data, and managing adverse events in alignment with regulatory and ethical standards.
  • Lead or contribute to creating essential documents such as study protocols, Investigator’s Brochures, regulatory submissions, and safety updates.
  • Drive strategic alignment within Clinical Development by promoting best practices and enhancing cross-functional processes.
  • Provide leadership for the Clinical Science team through talent acquisition, onboarding, training, performance management, and workforce planning.
  • Collaborate across departments—clinical operations, biostatistics, regulatory affairs—to ensure successful execution of clinical programs.

Qualifications

  • Bachelor’s degree in life sciences or healthcare; advanced degrees preferred.
  • Extensive knowledge of Good Clinical Practice (GCP) guidelines and drug development processes across Phases 1–3; expertise in oncology/immuno-oncology highly desirable.
  • Proven experience leading global clinical studies within pharmaceutical companies or CROs.
  • Advanced skills in data management systems (e.g., EDC systems) with a focus on optimizing processes for continuous improvement.
  • Strong ability to work effectively in matrixed environments while influencing stakeholders without direct authority.
  • Exceptional adaptability under tight deadlines combined with high organizational skills to prioritize tasks effectively.
  • Excellent verbal and written communication skills in English.