Global Development Product Lead (Sr Director)

JOB SUMMARY

·         Leads multiple (~1-3) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages, at which point molecule may be handed to the late-stage Oncology Development team for post-POC (typically phase 3) development

·         In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation.

·         Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community.

·         Develop clinical development plan from 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. 

JOB RESPONSIBILITIES

• Lead, develop and execute strategic development for early development assets. Lead cross-functional teams in collaboration with line function experts on the Global Product Teams (GPTs) to develop and drive an integrated product plan that addresses near-term technical uncertainties and ensures alignment with future pivotal development and commercialization success.
• Ensure timely execution and delivery of product milestones within budget.
• Communicate with executive management and governance committees to address program needs and provide recommendations. Ensure clear and effective product presentations and communications.
• Collaborate with partners on co-development programs to deliver a shared global product strategy, when applicable.
• Lead the team to set objectives, prioritize tasks, and ensure adherence to the plan and strategy
•   Manage risk by proactively identifying and resolving issues and developing contingency plans
• Oversee early development assets’ development broadly within a specific indication or group of indications. Typically, work on at least two 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, Global Development Team, and Study 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 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 Oncology R&D first-in-human clinical trials with input from Pfizer Oncology’s Oncology Research Unit, Regulatory Strategy, Clinical Pharmacology and Precision Medicine, 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.
• Contribute to br