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

  • Support clinical trials and the development strategy for early development assets and lead development programs with a focus on multiple myeloma cross-functionally within Pfizer Oncology, as well as represent the program with the external clinical community.
  • Develop clinical development plan from pre-IND stage to first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans.
  • To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
  • To support projects from Research to Proof of Concept at which point molecule may be handed to the late-stage Oncology Clinical Development team for post-POC (typically phase 3) development.
  • 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.