Pfizer

Senior Director, ( MD) Global Development Lead, Early Development

Pfizer

full-time

Posted on:

Origin:  • 🇺🇸 United States • California, Massachusetts, New York, Washington

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Salary

💰 $287,300 - $478,800 per year

Job Level

Senior

About the role

  • Lead, develop and execute strategic development for early development assets (myeloma-focused, with opportunities to work in other MOAs and oncology therapeutic areas in the early pipeline)
  • Oversee early development assets’ development broadly within a specific indication or group of indications
  • Typically, work on two to three clinical programs and support the development and provide consultation regarding multiple research projects
  • Work across the organization and on multifunctional teams responsible for the development of early development assets (including Product Team)
  • Oversee the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents
  • Provide leadership to early stage clinical scientists on the clinical study team for Early Development Assets, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists
  • Meet regularly with the Pfizer Oncology group leaders/surrogates across functions to increase mutual awareness and influence of emerging program targets, priorities and status
  • Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all Pfizer Oncology first-in-human clinical trials with input from Oncology Research Unit, Oncology Regulatory Strategy, Clinical Pharmacology and Precision Medicine, Oncology Clinical Development and Operations, Pharm Sci and Product Teams
  • Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies for early development assets
  • Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
  • Coordinate regular (at least quarterly and as needed) interactions with preferred clinical trials network and KOL advisory board to objectively consider and implement feedback
  • Drive innovations in early clinical development, and the application of translational oncology and precision medicine approaches
  • Collaborates with cross-functional leaders and teams to translate early preclinical discovery research into therapeutic candidates
  • Coordinates with business development to establish strategic external collaborations and foster new research projects and programs

Requirements

  • MD or MD-PhD with 5-10 years of industry experience in oncology, experience in multiple myeloma preferred, track record in early phase drug development
  • Clinical oncology experience: Board certification in oncology preferred
  • Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
  • Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
  • Demonstrated scientific productivity (publications, abstracts, etc.)
  • Proven scientific writing skills and good communication skills
  • Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
  • Capacity to adapt to a fast-paced and changing environment
  • Demonstrated history of effective leadership; including cross functional and matrixed teams, managing direct reports, and experience in seeking and maintaining alignment with cross-functional leaders
  • Demonstrates a passion for helping patients with cancer and for the science of oncology