Senior Director, Global Development Lead, Early Development

ROLE SUMMARY

• 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

ROLE RESPONSIBILITIES

• 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.

BASIC QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

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