Director, Clinical Science

BioNTechCambridge, MA
$168,100 - $268,700Hybrid

About The Position

At BioNTech, we are united by a shared mission to harness the power of science and innovation to transform lives. As Director, Clinical Science (m/f/d), you will lead and shape clinical development strategies, playing a critical role in advancing our investigational drugs from concept to reality. You will collaborate across diverse teams to ensure the successful design and execution of clinical trials, directly contributing to our goal of improving patient outcomes worldwide. This is your opportunity to lead with impact and be part of a transformative journey in healthcare.

Requirements

  • Advanced degree in life sciences/healthcare/nursing (e.g., PhD or PharmD preferred)
  • 10+ years of industry experience in clinical development or related fields with demonstrated leadership capabilities
  • Strong expertise in Good Clinical Practice (GCP), drug development processes (Phase 1–3), ideally paired with Oncology/Immuno-Oncology experience
  • Proven track record in leading global clinical studies within pharmaceutical companies or contract research organizations (CROs)
  • Deep understanding of clinical data collection systems (e.g., EDC systems) with experience driving process improvements for data analysis and reporting
  • Exceptional ability to lead cross-functional matrixed teams with strong influence skills
  • High adaptability with exceptional multitasking abilities under time pressure while maintaining quality standards
  • Strategic mindset combined with excellent prioritization skills for task implementation

Responsibilities

  • Lead the design of clinical trials by developing study protocols, identifying patient populations, selecting endpoints, and determining optimal study designs to evaluate investigational drugs
  • Provide strategic oversight for clinical trial execution, ensuring adherence to protocols, regulatory requirements, and ethical standards; monitor study progress, review data, and manage adverse event
  • Drive the creation of key study-level documents such as protocols, Investigator’s Brochures, regulatory submissions, safety updates, and publications
  • Address regulatory/health authority inquiries while ensuring compliance with guidelines; contribute to preparation for regulatory meetings
  • Develop and oversee the Clinical Development Plan and Integrated Evidence Plan while contributing to Target Product Profiles (TPPs)
  • Collaborate with cross-functional teams (e.g., clinical operations, biostatistics, medical safety) to ensure seamless execution of clinical development programs
  • Provide leadership in developing protocol-relevant training materials for internal teams, investigator sites, CRO partners, and other stakeholders
  • Partner with pharmacovigilance teams on safety evaluations and signal detection; contribute to aggregate reports and patient narrative reviews
  • Guide data review strategies to ensure integrity across studies; support Case Report Form (CRF) development and implementation of innovative data capture tools
  • Mentor junior team members within the clinical science organization while fostering a culture of continuous improvement

Benefits

  • competitive remuneration packages
  • annual bonus & equity (bonus and equity is variable and dependent on company and individual performance)
  • variety of benefits in support of our diverse employee base
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