Oncology Clinical Development Scientist, Director
Pfizer
19 days ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Position Summary: Provide scientific oversight, ensure data integrity and quality for clinical trial(s) supporting Late-Stage Oncology portfolio development strategy.
Key Responsibilities:
- Serve as clinical development expert for assigned studies; maintain current scientific/clinical knowledge in therapeutic/disease area.
- Partner with clinical/medical colleagues, clinical operations, and functional teams to implement and execute trials.
- Provide scientific oversight and ensure data integrity/quality.
- Represent study team in governance meetings and submissions; support Development Lead/Medical Director on study/disease strategy.
- Author protocols and study-level informed consent documents; contribute to IBs, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents; support Health Authority meeting preparations.
- Set clinical data review strategy; lead data collection/review of emerging trends; review/query data; present to governance bodies and stakeholders.
- In partnership with medically qualified colleagues, analyze emerging safety profile and communicate changes.
- Follow SOPs/regulations and applicable trainings; improve quality/efficiency; lead/participate in workgroups optimizing clinical development procedures; act as SME/business process owner for relevant SOP/procedure.
Minimum Qualifications:
- PhD/PharmD + 5 years, or MS + 7 years, or BA/BS + 10 years Clinical Research experience (industry/CRO).
- Phase 3/pivotal Oncology clinical research experience; ideally sponsor-side with successful regulatory submission/inspection/approval.
- Solid tumor or hematology trial experience; experience leading a team.
- Knowledge of clinical procedures, ICH, GCP; familiarity with FDA/EMA/global regulations.
- Experience across disciplines (e.g., Clinical Ops, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, QA).
- Experience with large data sets; Microsoft Office and relevant scientific software.
- Strong communication/presentation/organizational skills; collaborative problem-solving.
Preferred/Additional:
- Track record of scientific productivity (publications/posters/abstracts/presentations); proactive independent organization.
- Experience building cross-company partnerships.
Compensation/Benefits: Annual base salary range $176,600–$294,300; bonus target 20%; benefits include 401(k) with Pfizer matching, paid time off, caregiver/parental and medical leave, and health/dental/vision coverage.
Key Responsibilities:
- Serve as clinical development expert for assigned studies; maintain current scientific/clinical knowledge in therapeutic/disease area.
- Partner with clinical/medical colleagues, clinical operations, and functional teams to implement and execute trials.
- Provide scientific oversight and ensure data integrity/quality.
- Represent study team in governance meetings and submissions; support Development Lead/Medical Director on study/disease strategy.
- Author protocols and study-level informed consent documents; contribute to IBs, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents; support Health Authority meeting preparations.
- Set clinical data review strategy; lead data collection/review of emerging trends; review/query data; present to governance bodies and stakeholders.
- In partnership with medically qualified colleagues, analyze emerging safety profile and communicate changes.
- Follow SOPs/regulations and applicable trainings; improve quality/efficiency; lead/participate in workgroups optimizing clinical development procedures; act as SME/business process owner for relevant SOP/procedure.
Minimum Qualifications:
- PhD/PharmD + 5 years, or MS + 7 years, or BA/BS + 10 years Clinical Research experience (industry/CRO).
- Phase 3/pivotal Oncology clinical research experience; ideally sponsor-side with successful regulatory submission/inspection/approval.
- Solid tumor or hematology trial experience; experience leading a team.
- Knowledge of clinical procedures, ICH, GCP; familiarity with FDA/EMA/global regulations.
- Experience across disciplines (e.g., Clinical Ops, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, QA).
- Experience with large data sets; Microsoft Office and relevant scientific software.
- Strong communication/presentation/organizational skills; collaborative problem-solving.
Preferred/Additional:
- Track record of scientific productivity (publications/posters/abstracts/presentations); proactive independent organization.
- Experience building cross-company partnerships.
Compensation/Benefits: Annual base salary range $176,600–$294,300; bonus target 20%; benefits include 401(k) with Pfizer matching, paid time off, caregiver/parental and medical leave, and health/dental/vision coverage.