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Leads multiple cross functional oncology product teams from pre-clinical candidate nomination through Phase 1-2 clinical development and proof of concept stages. Drives the integration of cross functional molecule strategy and risk mitigation. Supports clinical trials and development strategy for early development assets within Pfizer Oncology.
Job Responsibility:
Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
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 cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations
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
Work across the organization and on multifunctional teams responsible for the development of early development assets
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
Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all Oncology R&D first-in-human clinical trials
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 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 broader organizational excellence as a member of the OESD department
Requirements:
MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including 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)
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 when applicable, 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
A proactive and strategic thinker, with strong data-driven decision-making skills
Ability to focus and motivate a team in a matrix organization with multiple stakeholders
Strong verbal, written, and presentation communication skills
Effective mentoring experience and skills
Highly collaborative with outstanding relationship building skills with internal company leadership, external development partners and investigators/medical professionals
Has a strong leadership presence and the ability to work effectively with other leaders. Ability to influence up and across the organization from an enterprise level
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
What we offer:
Participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility