Biontech Ag - Cambridge, MA

posted 5 months ago

Full-time - Senior
Cambridge, MA
1,001-5,000 employees
Professional, Scientific, and Technical Services

About the position

The Senior Director of Clinical Development for Personalized Cancer Vaccines at BioNTech will play a pivotal role in steering clinical strategies and overseeing the execution of clinical trials from early to late-stage development. This position involves leading a matrix team, ensuring patient safety, data integrity, and regulatory compliance while driving innovative approaches in clinical trial design.

Responsibilities

  • Oversee and steer the design and execution of clinical trials for assigned programs, creating clinical development plans for new compounds.
  • Work closely with the VP of Clinical Development to operationalize clinical strategies for portfolios and platforms.
  • Own strategy formulation and operational planning for assigned programs, driving integrated development and submission plans.
  • Assume Program Lead responsibilities, liaising with program managers and leading the program core team.
  • Translate Target Product Profile into clinical strategy and articulate targets to other development functions.
  • Responsible for study medical/safety aspects and risk-benefit assessments, collaborating with Pharmacovigilance on Risk Management Plans.
  • Supervise ongoing medical data review and resolve medical queries for running studies.
  • Ensure collaboration between clinical development and Clinical Operations teams for patient-centric drug development.
  • Drive innovation in program and trial design, including digital endpoints and synthetic control arms.
  • Prepare clinical sections of key documents, including Investigator's Brochures and responses to regulatory authorities.
  • Oversee the quality of Clinical Study Report medical content and provide guidance to the clinical development team.
  • Establish and manage relationships with key external stakeholders and represent the team in governance meetings.

Requirements

  • M.D. with a strong scientific and clinical background in Immuno-Oncology and Oncology.
  • Minimum of 10 years of experience in Immuno-Oncology and Oncology within biotech/pharmaceutical and academic settings, including leading clinical development programs from Phase I/II through Phase III and NDA submission.
  • Thorough understanding of clinical and scientific methods used in clinical development studies, including novel study designs and application of companion diagnostics.
  • Experience with confirmatory Phase III trial design and dossier preparation for submission activities.
  • Familiarity with global health authority interactions (EMA, FDA, MHRA, CDE) and experience in drug development program registration is advantageous.
  • Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data.
  • Demonstrated leadership experience with over 2 years of line management experience in a global matrix organization.

Nice-to-haves

  • Experience in mentoring and accelerating capabilities of team members.
  • Ability to apply situational management styles effectively.

Benefits

  • Competitive remuneration packages based on role, location, qualifications, and experience.
  • Diverse employee support benefits, though specifics may vary by location.
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