Senior Director, Global Development Lead, Early Development

Role Summary

Support clinical trials and the development strategy for early development assets and lead development programs 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-Proof of Concept (typically phase 3) development

Responsibilities

• Lead, develop and execute strategic development for early development assets in hematologic malignancies and solid tumors across different MOAs including antibody drug conjugates
• 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.

Qualifications

• MD or MD-PhD with 5+ years of industry experience in oncology, experience in antibody drug conjugates preferred, track record in early phase drug development.
• 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

• Clinical oncology experience: Board certification in oncology preferred.
• Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders.
• Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
• Is a team player, works well in a team environment both as a leader and a key contributor.
• Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds, and geographies.

Work Location

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.