Oncology Clinical Development Scientist, Director
Pfizer
19 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
- Provide scientific oversight, ensure data integrity and quality for clinical trial(s) supporting late-stage oncology development programs.
Key Responsibilities
- Serve as clinical development expert for assigned studies; maintain current scientific/clinical knowledge in relevant therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, and cross-functional teams to execute trials within the program.
- Own scientific oversight, data integrity, and trial quality.
- Represent the study team in governance meetings and submissions; support Development Lead/Medical Director on study and disease-area strategy.
- Author/contribute to protocols, informed consent documents, investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents.
- Define and lead clinical data review strategy; review/query data; present emerging trends to internal/external stakeholders.
- Monitor emerging safety profile in partnership with medical/safety colleagues and communicate updates.
- Follow SOPs/regulations and trainings; drive quality/efficiency improvements; lead/participate in workgroups to optimize clinical development procedures.
Minimum Qualifications
- PhD/PharmD with 5+ years, or MS with 7+ years, or BA/BS with 10+ years clinical research experience in industry/CRO.
- Phase 3/pivotal oncology experience; preferably sponsor-side with successful submissions/inspections/approvals.
- Solid tumor or hematology trial experience; experience leading a team.
- Strong knowledge of clinical procedures, ICH, GCP, and FDA/EMA/global regulations; experience with large datasets.
- Proficiency with Microsoft Office and scientific software; excellent communication/presentation/organizational skills; track record of scientific productivity.
Benefits (explicitly listed)
- 401(k) with company matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.
- Base salary range: $176,600–$294,300; bonus target 20%.
- Provide scientific oversight, ensure data integrity and quality for clinical trial(s) supporting late-stage oncology development programs.
Key Responsibilities
- Serve as clinical development expert for assigned studies; maintain current scientific/clinical knowledge in relevant therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, and cross-functional teams to execute trials within the program.
- Own scientific oversight, data integrity, and trial quality.
- Represent the study team in governance meetings and submissions; support Development Lead/Medical Director on study and disease-area strategy.
- Author/contribute to protocols, informed consent documents, investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents.
- Define and lead clinical data review strategy; review/query data; present emerging trends to internal/external stakeholders.
- Monitor emerging safety profile in partnership with medical/safety colleagues and communicate updates.
- Follow SOPs/regulations and trainings; drive quality/efficiency improvements; lead/participate in workgroups to optimize clinical development procedures.
Minimum Qualifications
- PhD/PharmD with 5+ years, or MS with 7+ years, or BA/BS with 10+ years clinical research experience in industry/CRO.
- Phase 3/pivotal oncology experience; preferably sponsor-side with successful submissions/inspections/approvals.
- Solid tumor or hematology trial experience; experience leading a team.
- Strong knowledge of clinical procedures, ICH, GCP, and FDA/EMA/global regulations; experience with large datasets.
- Proficiency with Microsoft Office and scientific software; excellent communication/presentation/organizational skills; track record of scientific productivity.
Benefits (explicitly listed)
- 401(k) with company matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.
- Base salary range: $176,600–$294,300; bonus target 20%.