Global Development Lead, Late Stage

hace 1 semana


Tarragona, Tarragona, España Pfizer Belgium A tiempo completo

Role Summary

The Senior Clinical Development Lead will be responsible for defining and executing the development strategy of two assets at different stages.

Reporting to the Vice President, GYN/GI/Melanoma Therapeutic Area Head, the successful candidate should have demonstrated proficiency in leading and/or supporting development programs, cross-functional collaboration, and representing programs externally.

Key Responsibilities

  • Lead product-specific Global Development Teams
  • Serve as the subject matter expert on clinical issues
  • Work across the organization and on the cross-functional Global Development Team to lead, develop, and execute the clinical development plan of TIVDAK in cervical cancer and another new molecular entity entering late-stage clinical development
  • Endorse clinical decisions in advance of GPT, senior management reviews, or governance bodies
  • Provide oversight and management responsibilities of medical director(s)
  • Accountable for the clinical development strategy, trial design, execution, and delivery of trial results
  • Accountable for integrating regulatory, statistical, and other internal and external stakeholder input into study designs
  • Serve as the primary interface with the Development Review Committee
  • Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
  • Oversee the evaluation, interpretation, reporting, and presentation of study data
  • Accountable for safety and clinical pharmacology for defining and identifying optimal dose and schedule selection
  • Accountable for regulatory for health authority interactions
  • May participate in evaluating business development opportunities

Basic Qualifications

  • Medical degree or an advanced degree with relevant clinical/industry experience (typically 4+ years)
  • 7+ years industry experience
  • 5+ years of experience leading diverse teams

Preferred Qualifications

  • Board certified/eligible in oncology or equivalent
  • Experience across multiple phases of clinical development and across drug classes in oncology
  • Experience in leading NDA, BLA, or MAA


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