Senior Director/Team Head--Oncology Late Stage Data Review
Pfizer
4 hours ago
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Role Responsibilities:
- Serve as clinical development data and AI expert for assigned late-stage (Phase 2–3) studies; maintain clinical knowledge in assigned therapeutic/disease area(s).
- Partner with clinical/medical colleagues, clinical operations, data management, digital, and other functions to implement and execute clinical data deliverables in the Oncology Late Stage Portfolio.
- Hold colleagues/reports accountable; manage conflicting priorities; apply strong clinical judgment to ensure scientific oversight, data integrity, and quality.
- Set the clinical data review strategy; lead review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs and regulations; complete applicable trainings; seek opportunities to improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio- and enterprise-level workgroups to optimize data procedures.
- Serve as subject matter expert/business process owner for relevant SOPs/procedures as needed.
- Manage line reports and/or contingent workers; clarify purpose/priorities; develop talent.
Minimum Qualifications:
- Science-related PhD or PharmD with 7+ years clinical research in industry, OR MS with 10+ years, OR BA/BS with 12+ years.
- Phase 3/pivotal Oncology sponsor-side clinical research and data experience with track record of successful regulatory submission, inspection, and approval.
- Knowledge of clinical procedures, ICH, GCP; familiarity with FDA, EMA, and global regulations.
- Experience applying AI to streamline/accelerate data review, reporting, and visualization.
- Experience with large data sets; strong cross-functional stakeholder experience.
- Strong communication skills (verbal/presentation).
- 10+ years supervisory experience managing 10–20 team members.
Competencies for Success:
- Embrace evolving technologies (including AI) and adopt best practices to improve efficiency/quality of clinical data review.
- Adapt to change while maintaining integrity/quality.
- Demonstrate autonomous delivery, problem-solving, and agile decision-making.
Work Location:
- Hybrid; live within commuting distance; work on-site ~2.5 days/week.
- Serve as clinical development data and AI expert for assigned late-stage (Phase 2–3) studies; maintain clinical knowledge in assigned therapeutic/disease area(s).
- Partner with clinical/medical colleagues, clinical operations, data management, digital, and other functions to implement and execute clinical data deliverables in the Oncology Late Stage Portfolio.
- Hold colleagues/reports accountable; manage conflicting priorities; apply strong clinical judgment to ensure scientific oversight, data integrity, and quality.
- Set the clinical data review strategy; lead review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs and regulations; complete applicable trainings; seek opportunities to improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio- and enterprise-level workgroups to optimize data procedures.
- Serve as subject matter expert/business process owner for relevant SOPs/procedures as needed.
- Manage line reports and/or contingent workers; clarify purpose/priorities; develop talent.
Minimum Qualifications:
- Science-related PhD or PharmD with 7+ years clinical research in industry, OR MS with 10+ years, OR BA/BS with 12+ years.
- Phase 3/pivotal Oncology sponsor-side clinical research and data experience with track record of successful regulatory submission, inspection, and approval.
- Knowledge of clinical procedures, ICH, GCP; familiarity with FDA, EMA, and global regulations.
- Experience applying AI to streamline/accelerate data review, reporting, and visualization.
- Experience with large data sets; strong cross-functional stakeholder experience.
- Strong communication skills (verbal/presentation).
- 10+ years supervisory experience managing 10–20 team members.
Competencies for Success:
- Embrace evolving technologies (including AI) and adopt best practices to improve efficiency/quality of clinical data review.
- Adapt to change while maintaining integrity/quality.
- Demonstrate autonomous delivery, problem-solving, and agile decision-making.
Work Location:
- Hybrid; live within commuting distance; work on-site ~2.5 days/week.