Global Development Product Lead (Sr Director)
Pfizer
1 month ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead 1–3 cross-functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1–2 development and proof of concept (POC); hand off to late-stage Oncology Development (typically Phase 3) when applicable.
- Integrate end-to-end molecule strategy and risk mitigation; ensure data-driven milestone delivery via risk identification and mitigation.
- Support clinical trials and early development strategy across multiple Pfizer Oncology functions; represent the program externally.
- Develop first-in-human-to-POC clinical development plans, including combination assessment and predictive/pharmacodynamics biomarker strategies.
- Lead development of clinical protocols/amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Oversee early asset safety/pharmacology/efficacy evaluation; drive PK-guided dose escalation and early combination strategies.
- Coordinate with clinical trials networks/KOLs; publish and present (manuscripts, abstracts, presentations).
- Translate preclinical discovery into candidates; coordinate external collaborations.
Qualifications / Skills:
- MD or MD-PhD with 5+ years of industry experience (required).
- Oncology clinical research/early-phase drug development experience (preferred); oncology board certification (preferred).
- Clinical leadership in clinical/translational/basic biomedical research; understanding of biostatistics, regulatory, pre-clinical pharmacology, and pharmaceutical sciences.
- Demonstrated scientific productivity and strong writing/communication skills.
- Proven leadership; ability to defend clinical plan at governance meetings; capacity in fast-paced, matrixed environments.
Benefits:
- Participation in Global Performance Plan (25% bonus target) and long-term incentive eligibility; comprehensive health benefits and 401(k) contributions.
- Relocation support may be available.
- Lead 1–3 cross-functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1–2 development and proof of concept (POC); hand off to late-stage Oncology Development (typically Phase 3) when applicable.
- Integrate end-to-end molecule strategy and risk mitigation; ensure data-driven milestone delivery via risk identification and mitigation.
- Support clinical trials and early development strategy across multiple Pfizer Oncology functions; represent the program externally.
- Develop first-in-human-to-POC clinical development plans, including combination assessment and predictive/pharmacodynamics biomarker strategies.
- Lead development of clinical protocols/amendments, investigator brochures, clinical study reports, statistical analysis plans, and regulatory documents.
- Oversee early asset safety/pharmacology/efficacy evaluation; drive PK-guided dose escalation and early combination strategies.
- Coordinate with clinical trials networks/KOLs; publish and present (manuscripts, abstracts, presentations).
- Translate preclinical discovery into candidates; coordinate external collaborations.
Qualifications / Skills:
- MD or MD-PhD with 5+ years of industry experience (required).
- Oncology clinical research/early-phase drug development experience (preferred); oncology board certification (preferred).
- Clinical leadership in clinical/translational/basic biomedical research; understanding of biostatistics, regulatory, pre-clinical pharmacology, and pharmaceutical sciences.
- Demonstrated scientific productivity and strong writing/communication skills.
- Proven leadership; ability to defend clinical plan at governance meetings; capacity in fast-paced, matrixed environments.
Benefits:
- Participation in Global Performance Plan (25% bonus target) and long-term incentive eligibility; comprehensive health benefits and 401(k) contributions.
- Relocation support may be available.