Global Development Product Lead (Sr Director)
Pfizer
1 month ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Job Responsibilities
- 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), with potential handoff to late-stage Oncology Development for post-POC (typically Phase 3) development.
- Integrates an end-to-end cross-functional molecule strategy and risk mitigation plan with functional experts; ensures delivery of data-driven milestones through risk identification and mitigation.
- Supports clinical trials and development strategy for early development assets and lead development programs across multiple Pfizer Oncology functions; represents the program with the external clinical community.
- Develops clinical development plan from first-in-human to POC, including assessment of appropriate combinations and evaluation of predictive and pharmacodynamics biomarker plans.
- Provides clinical components and clinical expertise to project teams, including medical monitoring of clinical trials.
- Leads strategic development for early development assets; develops and drives an integrated product plan aligned to future pivotal development and commercialization success.
- Ensures timely execution and delivery of product milestones within budget.
- Communicates with executive management and governance committees; provides recommendations and effective product presentations.
- Collaborates with partners on co-development programs to deliver a shared global product strategy.
- Sets objectives, prioritizes tasks, and ensures adherence to the plan and strategy.
- Manages risk by proactively identifying/resolving issues and developing contingency plans.
- Oversees early development assets broadly within an indication/group of indications (typically at least two clinical programs).
- Works across the organization on multifunctional teams (Product Team, Global Development Team, Study team).
- Oversees development/management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Leads and mentors early-stage clinical scientists in a matrix environment (clinicians, statisticians, clinical pharmacologists, translational biologists, regulatory specialists).
- Implements PK-guided dose escalation, early combination strategies, and emerging innovations for all Oncology R&D first-in-human clinical trials.
- Oversees evaluation of safety, pharmacology, and efficacy data from ongoing/completed studies.
- Oversees manuscripts, abstracts, and presentations for scientific meetings and advisory boards.
- Conducts literature reviews and prepares summaries to support clinical development programs.
- Acts as a medical resource for design and interpretation of clinical and preclinical programs.
- Coordinates regular (at least quarterly and as needed) interactions with clinical trials network and KOL advisory board to consider and implement feedback.
- Drives innovations in early clinical development using translational oncology and precision medicine approaches.
- Collaborates to translate early preclinical discovery research into therapeutic candidates.
- Coordinates with business development on strategic external collaborations and new research projects/programs.
Qualifications / Skills
- MD or MD-PhD with 5+ years of industry experience (required).
- Oncology drug development experience; track record in oncology clinical research including early-phase drug development (preferred).
- Clinical oncology experience: board certification in oncology (preferred).
- Significant industry leadership experience in clinical, translational, or basic research in biomedical sciences or drug-development-related disciplines.
- Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing and communication skills.
- Proven leadership skills, including ability to defend the clinical plan at governance meetings (essential).
- Capacity to adapt to a fast-paced, changing environment.
- Demonstrated effective leadership in cross-functional and matrixed teams; managing direct reports when applicable; seeking and maintaining alignment with cross-functional leaders.
- Passion for helping patients with cancer and for the science of oncology.
- Proactive, strategic, data-driven decision-making.
- Ability to focus/motivate a matrix team with multiple stakeholders.
- Strong verbal, written, and presentation communication skills.
- Experience with staff management and mentoring.
- Highly collaborative; strong relationship-building with internal leadership, external development partners, and investigators/medical professionals.
- Strong leadership presence and ability to work effectively with other leaders.
- Team player.
- Global perspective; ability to work across cultures, backgrounds, and geographies.
- 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), with potential handoff to late-stage Oncology Development for post-POC (typically Phase 3) development.
- Integrates an end-to-end cross-functional molecule strategy and risk mitigation plan with functional experts; ensures delivery of data-driven milestones through risk identification and mitigation.
- Supports clinical trials and development strategy for early development assets and lead development programs across multiple Pfizer Oncology functions; represents the program with the external clinical community.
- Develops clinical development plan from first-in-human to POC, including assessment of appropriate combinations and evaluation of predictive and pharmacodynamics biomarker plans.
- Provides clinical components and clinical expertise to project teams, including medical monitoring of clinical trials.
- Leads strategic development for early development assets; develops and drives an integrated product plan aligned to future pivotal development and commercialization success.
- Ensures timely execution and delivery of product milestones within budget.
- Communicates with executive management and governance committees; provides recommendations and effective product presentations.
- Collaborates with partners on co-development programs to deliver a shared global product strategy.
- Sets objectives, prioritizes tasks, and ensures adherence to the plan and strategy.
- Manages risk by proactively identifying/resolving issues and developing contingency plans.
- Oversees early development assets broadly within an indication/group of indications (typically at least two clinical programs).
- Works across the organization on multifunctional teams (Product Team, Global Development Team, Study team).
- Oversees development/management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Leads and mentors early-stage clinical scientists in a matrix environment (clinicians, statisticians, clinical pharmacologists, translational biologists, regulatory specialists).
- Implements PK-guided dose escalation, early combination strategies, and emerging innovations for all Oncology R&D first-in-human clinical trials.
- Oversees evaluation of safety, pharmacology, and efficacy data from ongoing/completed studies.
- Oversees manuscripts, abstracts, and presentations for scientific meetings and advisory boards.
- Conducts literature reviews and prepares summaries to support clinical development programs.
- Acts as a medical resource for design and interpretation of clinical and preclinical programs.
- Coordinates regular (at least quarterly and as needed) interactions with clinical trials network and KOL advisory board to consider and implement feedback.
- Drives innovations in early clinical development using translational oncology and precision medicine approaches.
- Collaborates to translate early preclinical discovery research into therapeutic candidates.
- Coordinates with business development on strategic external collaborations and new research projects/programs.
Qualifications / Skills
- MD or MD-PhD with 5+ years of industry experience (required).
- Oncology drug development experience; track record in oncology clinical research including early-phase drug development (preferred).
- Clinical oncology experience: board certification in oncology (preferred).
- Significant industry leadership experience in clinical, translational, or basic research in biomedical sciences or drug-development-related disciplines.
- Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing and communication skills.
- Proven leadership skills, including ability to defend the clinical plan at governance meetings (essential).
- Capacity to adapt to a fast-paced, changing environment.
- Demonstrated effective leadership in cross-functional and matrixed teams; managing direct reports when applicable; seeking and maintaining alignment with cross-functional leaders.
- Passion for helping patients with cancer and for the science of oncology.
- Proactive, strategic, data-driven decision-making.
- Ability to focus/motivate a matrix team with multiple stakeholders.
- Strong verbal, written, and presentation communication skills.
- Experience with staff management and mentoring.
- Highly collaborative; strong relationship-building with internal leadership, external development partners, and investigators/medical professionals.
- Strong leadership presence and ability to work effectively with other leaders.
- Team player.
- Global perspective; ability to work across cultures, backgrounds, and geographies.