Senior Director/Team Head--Oncology Late Stage Data Review
Pfizer
19 days ago
Remote friendly (Bothell, WA)
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 areas.
- 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 reports accountable; manage conflicting stakeholder priorities; apply strong clinical judgment to ensure scientific oversight, data integrity, and quality.
- Set clinical data review strategy; lead team review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs and regulations; complete required trainings; improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio and enterprise workgroups optimizing data procedures.
- Act as a potential subject matter expert or business process owner for relevant SOPs/procedures.
- Manage line reports/contingent workers; provide clarity of priorities and develop talent.
Minimum Qualifications:
- Science-related PhD or PharmD with 7+ years clinical research experience in industry, OR MS with 10+ years, OR BA/BS with 12+ years.
- Phase 3/pivotal Oncology clinical research and data experience on sponsor side with successful regulatory submission/inspection/approval track record.
- Knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA/global regulations.
- Experience applying AI to streamline/accelerate data review, reporting, and visualization.
- Experience working with large data sets.
- Strong cross-functional internal/external stakeholder experience.
- Strong communication and presentation skills.
- 10+ years supervisory experience managing teams of 10–20.
Competencies for Success:
- Embrace evolving technologies (incl. AI) and adopt best practices to improve clinical data review efficiency/quality.
- Adapt to changing environments while maintaining integrity and work quality.
- Autonomous delivery, problem-solving, and agile decision-making.
Work Location:
- Hybrid; live within commuting distance and 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 areas.
- 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 reports accountable; manage conflicting stakeholder priorities; apply strong clinical judgment to ensure scientific oversight, data integrity, and quality.
- Set clinical data review strategy; lead team review, reporting, and optimization of data analysis; present to stakeholders as needed.
- Follow relevant SOPs and regulations; complete required trainings; improve quality and efficiency of clinical data procedures.
- Lead or participate in portfolio and enterprise workgroups optimizing data procedures.
- Act as a potential subject matter expert or business process owner for relevant SOPs/procedures.
- Manage line reports/contingent workers; provide clarity of priorities and develop talent.
Minimum Qualifications:
- Science-related PhD or PharmD with 7+ years clinical research experience in industry, OR MS with 10+ years, OR BA/BS with 12+ years.
- Phase 3/pivotal Oncology clinical research and data experience on sponsor side with successful regulatory submission/inspection/approval track record.
- Knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA/global regulations.
- Experience applying AI to streamline/accelerate data review, reporting, and visualization.
- Experience working with large data sets.
- Strong cross-functional internal/external stakeholder experience.
- Strong communication and presentation skills.
- 10+ years supervisory experience managing teams of 10–20.
Competencies for Success:
- Embrace evolving technologies (incl. AI) and adopt best practices to improve clinical data review efficiency/quality.
- Adapt to changing environments while maintaining integrity and work quality.
- Autonomous delivery, problem-solving, and agile decision-making.
Work Location:
- Hybrid; live within commuting distance and work on-site ~2.5 days/week.