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Executive Director, Clinical Science

BioNTech SE
Full-time
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development

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Role Summary

Executive Director, Clinical Science and Clinical Center of Excellence leads a best-in-class Clinical Science and Center of Excellence function to design and deliver early and late phase clinical studies. Serves on the Global Development Leadership Team, manages a team of Clinical Scientists, oversees the pipeline of clinical programs, and drives cross-functional collaboration to achieve objectives and timelines. Recruits leaders and contributors and establishes the vision, mission, and culture of the team.

Responsibilities

  • Supports resource forecasting, talent development, succession planning, and retention strategies.
  • Builds a collaborative, supportive learning environment.
  • Ensures and contributes to consistent, high-quality training for Clinical Scientists, including SOPs and Working Practices.
  • May serve as a delegate for Clinical Development Portfolio VPs as needed.
  • Partners with Clinical Development VPs to advance the portfolio/pipeline.
  • Leads teams to ensure high-quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings.
  • Oversees the portfolio/pipeline of clinical studies to ensure consistency of clinical deliverables across programs.
  • Ensures high-quality and timely delivery of protocols and data; implements quality assurance plans with the QA organization.
  • Partners with QA and GDO to embed and operationalize Quality by Design throughout the trial lifecycle.
  • Develops metrics to track output and trends in protocol development for continuous improvement.
  • Serves as a clinical science/development subject matter expert to support quality and compliance across therapeutic areas and guide compliance to GCP.
  • Maintains an advanced understanding of the status of all trial activities.
  • Champions clinical trial innovation (designs, dose escalation, decentralized trials, EMR to EDC, AI, real-world data) to accelerate trials and reduce patient/site burden.
  • Serves as an internal SME on best practices and industry standards in clinical science/development excellence.
  • Leads resourcing and budget planning for the Clinical Science/Development organization, including contractors and FSPs.
  • Leads development and delivery of educational/training programs to advance capabilities and foster a community of practitioners.
  • Leads team developing/maintaining clinical processes across Early and Late Development; supports quality/compliance activities.
  • Holds accountability for the performance and professional development of the Clinical Scientist team.
  • Serves as a cross-functional collaborator representing Clinical Science in process improvement initiatives and cross-functional activities.
  • Collaborates to support incoming asset and/or business development activities (e.g., due diligence).

Qualifications

  • An advanced scientific degree is required (PhD, PharmD, or MD) with a minimum of 15 years of related experience.
  • Experience managing clinical teams accountable for delivery of a portfolio of studies.

Skills

  • Proven leadership, people management, enterprise mindset, and process improvement.
  • Strong communication, diplomacy, and relationship-building skills.
  • Ability to articulate strengths/limitations, develop plans, and build talent.
  • Commitment to scientific excellence, multidisciplinary problem solving, urgency, teamwork, and quality.
  • Ability to anticipate needs, manage risks, and demonstrate financial acumen.
  • Ability to foster morale and belonging, take responsibility for results, and navigate organizational changes.
  • Recognition as a technical/functional expert in clinical science with leadership skills.
  • Promotes continuous improvement and innovation; mentors others in conflict management and consensus-building.
  • Willingness to take calculated risks to drive innovation.

Education

  • Advanced degree as listed in Qualifications: PhD, PharmD, or MD.

Additional Requirements

  • Travel: 20% travel required.