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Global Development Product Lead (Sr Director)

Pfizer
1 month ago
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead 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); may transition the molecule to late-stage Oncology Development for post-POC (typically Phase 3) development.
- Integrate an end-to-end cross-functional molecule strategy and risk mitigation plan with functional experts; ensure delivery of data-driven milestones through risk identification and mitigation.
- Support clinical trials and development strategy for early development assets and lead development programs across multiple Pfizer Oncology functions; represent programs with the external clinical community.
- Develop clinical development plans from first-in-human to POC, including assessment of appropriate combinations and evaluation of predictive and pharmacodynamics biomarker plans.
- Ensure clinical plan components and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
- Lead strategic development for early development assets; develop and execute an integrated product plan addressing near-term technical uncertainties and aligning with pivotal development and commercialization.
- Ensure timely execution and delivery of product milestones within budget.
- Communicate with executive management and governance committees; provide recommendations and clear product presentations/communications.
- Collaborate on co-development programs to deliver shared global product strategy (as applicable).
- Set objectives, prioritize tasks, and ensure adherence to plan and strategy.
- Proactively identify and resolve issues, manage risk, and develop contingency plans.
- Oversee early development assets within specific indications/group of indications (typically at least two clinical programs) and consult on multiple research projects.
- Work across multifunctional teams (Product, Global Development, and Study teams).
- Oversee clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Provide leadership to early-stage clinical scientists in matrix teams; meet regularly with oncology group leaders/surrogates across functions.
- Implement PK-guided dose escalation, early combination strategies, and emerging innovations on first-in-human Oncology R&D trials.
- Oversee evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies.
- Oversee manuscripts, abstracts, and presentations for scientific meetings and advisory boards.
- Conduct literature reviews and prepare summaries to support clinical development programs.
- Serve as medical resource for design and interpretation of clinical and preclinical programs for existing and new candidates.
- Coordinate regular interactions (at least quarterly and as needed) with clinical trials networks and KOL advisory boards to consider and implement feedback.
- Drive innovations in early clinical development using translational oncology and precision medicine approaches.
- Translate early preclinical discovery research into therapeutic candidates with cross-functional leaders.
- Coordinate 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 related drug development 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 ability to defend the clinical plan at governance meetings (essential).
- Ability to adapt to fast-paced, changing environments.
- Demonstrated history of effective leadership in cross-functional/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 thinker with strong data-driven decision-making.
- Ability to focus and motivate teams in matrix organizations with multiple stakeholders.
- Strong verbal, written, and presentation communication skills.
- Staff management and mentoring experience.
- Highly collaborative with strong relationship-building skills with internal/external partners and investigators/medical professionals.
- Strong leadership presence.
- Team player; works well as both leader and contributor.
- Global perspective and ability to work across cultures, backgrounds, and geographies.