Senior Director/Team Head--Oncology Late Stage Data Review
Pfizer
18 days ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role Summary
You will be responsible for setting data oversight, integrity, analysis, quality, and consistent adoption of AI and best practices in support of the data strategy for the Late-Stage Oncology portfolio. Manage and mentor colleagues/contingent workers across several Oncology indications and develop talent within the team.
Role Responsibilities
- Clinical development data and AI expert for assigned late-stage (Phase 2–3) studies; maintain clinical knowledge in assigned therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, data management, digital, and other functions to implement and execute clinical data deliverables within the Oncology Late Stage Portfolio.
- Hold colleagues/reports accountable; manage conflicting priorities; apply strong clinical judgment to ensure scientific oversight and data integrity/quality.
- Set clinical data review strategy; lead review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs/regulations and required trainings; seek opportunities to improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio/enterprise workgroups to optimize data procedures.
- Serve as SME/business process owner for relevant SOP/procedure as needed.
- Manage line reports/contingent workers; provide clarity of purpose and priorities; develop talent.
Minimum Qualifications
- Science-related PhD or PharmD with 7+ years clinical research (industry) OR MS with 10+ years OR BA/BS with 12+ years.
- Oncology Phase 3/pivotal sponsor-side clinical research and data experience with successful regulatory submission/inspection/approval track record.
- 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 verbal and presentation communication skills.
- 10+ years supervisory experience with 10–20 team members.
Competencies for Success
- Embrace evolving technologies (including AI) to improve efficiency/quality of clinical data review.
- Adapt to changing environments 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.
You will be responsible for setting data oversight, integrity, analysis, quality, and consistent adoption of AI and best practices in support of the data strategy for the Late-Stage Oncology portfolio. Manage and mentor colleagues/contingent workers across several Oncology indications and develop talent within the team.
Role Responsibilities
- Clinical development data and AI expert for assigned late-stage (Phase 2–3) studies; maintain clinical knowledge in assigned therapeutic/disease areas.
- Partner with clinical/medical colleagues, clinical operations, data management, digital, and other functions to implement and execute clinical data deliverables within the Oncology Late Stage Portfolio.
- Hold colleagues/reports accountable; manage conflicting priorities; apply strong clinical judgment to ensure scientific oversight and data integrity/quality.
- Set clinical data review strategy; lead review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs/regulations and required trainings; seek opportunities to improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio/enterprise workgroups to optimize data procedures.
- Serve as SME/business process owner for relevant SOP/procedure as needed.
- Manage line reports/contingent workers; provide clarity of purpose and priorities; develop talent.
Minimum Qualifications
- Science-related PhD or PharmD with 7+ years clinical research (industry) OR MS with 10+ years OR BA/BS with 12+ years.
- Oncology Phase 3/pivotal sponsor-side clinical research and data experience with successful regulatory submission/inspection/approval track record.
- 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 verbal and presentation communication skills.
- 10+ years supervisory experience with 10–20 team members.
Competencies for Success
- Embrace evolving technologies (including AI) to improve efficiency/quality of clinical data review.
- Adapt to changing environments 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.