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BioNTech SE · 1 day ago

Senior Director/Director Clinical Development

Cambridge, MA

Full-time

Onsite

Director/Executive

$267K/yr - $397K/yr

BioNTech SE is a company focused on innovative strategies in clinical development, and they are seeking a Senior Director/Director of Clinical Development to oversee the design and execution of clinical trials. This role involves ensuring data integrity, patient safety, and regulatory approval while leading matrix teams in the field of Immuno-Oncology and Oncology.

Health Care

Responsibilities

Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval

Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions

Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes

Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries

Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes

Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports

Build strong relationships with external stakeholders while representing the team in governance meetings

Qualification

Clinical DevelopmentImmuno-OncologyOncologyClinical Trial DesignRegulatory ApprovalBiostatisticsMedical AcumenStakeholder ManagementLeadership Skills

Required

M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology

Extensive experience leading clinical development programs across Phases I–III, including NDA submissions

Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design

Proven experience interacting globally with health authorities (e.g., EMA, FDA), with successful registration being advantageous

Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes

Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles