Clinical Development Scientist, Director (Inflammation and Immunology)
Pfizer
9 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
- Provide medical and scientific leadership for one or more complex clinical trials in Inflammation and Immunology.
- Ensure clinical integrity, scientific quality, and patient safety; partner with Clinical Operations and cross-functional stakeholders to deliver high-quality, efficient trials.
- Lead protocol development, study execution, data interpretation, and risk management; serve as primary clinical contact for investigators and internal teams.
- Drive integration of AI-enabled and advanced analytics solutions to improve clinical development speed, efficiency, and decision-making.
Key Responsibilities
- Core Clinical Leadership: Lead clinical execution of medium- to high-complexity studies; lead protocol design/development; partner cross-functionally; oversee clinical data review and safety surveillance; serve as primary clinical contact.
- AI-Enabled Clinical Development & Innovation: Identify and implement AI/ML and advanced analytics tools to optimize trial design/execution; partner with Data Science/Digital/Technology to translate AI use cases into scalable workflows; champion adoption across study teams.
- Clinical Strategy and Deliverables: Contribute to clinical documents (protocols, CSRs, regulatory submissions); support risk management and safety review; incorporate AI-derived insights into clinical strategy and deliverables.
Minimum Qualifications
- PhD/PharmD (5+ years), or MS (7+ years), or BS/BA (8+ years) in relevant science with biopharma clinical research experience.
- Deep knowledge of clinical development, ICH/GCP, global regulatory requirements, and safety management.
- Experience leading complex studies in cross-functional, global teams.
- Strong written/verbal communication with internal/external stakeholders.
- Experience applying AI/ML/advanced analytics in clinical development (e.g., protocol optimization, site feasibility, query automation, data cleaning/anomaly detection/signal identification, safety risk prediction).
- Familiarity with AI-enabled use cases; experience partnering with data science/digital teams.
- Understanding of data governance and AI considerations in GxP.
Preferred Qualifications
- Advanced degree/certification; respiratory and/or dermatology therapeutic area experience.
- Real-world data, digital endpoints, or innovative clinical technologies.
Application Instructions
- None provided in the text.
- Provide medical and scientific leadership for one or more complex clinical trials in Inflammation and Immunology.
- Ensure clinical integrity, scientific quality, and patient safety; partner with Clinical Operations and cross-functional stakeholders to deliver high-quality, efficient trials.
- Lead protocol development, study execution, data interpretation, and risk management; serve as primary clinical contact for investigators and internal teams.
- Drive integration of AI-enabled and advanced analytics solutions to improve clinical development speed, efficiency, and decision-making.
Key Responsibilities
- Core Clinical Leadership: Lead clinical execution of medium- to high-complexity studies; lead protocol design/development; partner cross-functionally; oversee clinical data review and safety surveillance; serve as primary clinical contact.
- AI-Enabled Clinical Development & Innovation: Identify and implement AI/ML and advanced analytics tools to optimize trial design/execution; partner with Data Science/Digital/Technology to translate AI use cases into scalable workflows; champion adoption across study teams.
- Clinical Strategy and Deliverables: Contribute to clinical documents (protocols, CSRs, regulatory submissions); support risk management and safety review; incorporate AI-derived insights into clinical strategy and deliverables.
Minimum Qualifications
- PhD/PharmD (5+ years), or MS (7+ years), or BS/BA (8+ years) in relevant science with biopharma clinical research experience.
- Deep knowledge of clinical development, ICH/GCP, global regulatory requirements, and safety management.
- Experience leading complex studies in cross-functional, global teams.
- Strong written/verbal communication with internal/external stakeholders.
- Experience applying AI/ML/advanced analytics in clinical development (e.g., protocol optimization, site feasibility, query automation, data cleaning/anomaly detection/signal identification, safety risk prediction).
- Familiarity with AI-enabled use cases; experience partnering with data science/digital teams.
- Understanding of data governance and AI considerations in GxP.
Preferred Qualifications
- Advanced degree/certification; respiratory and/or dermatology therapeutic area experience.
- Real-world data, digital endpoints, or innovative clinical technologies.
Application Instructions
- None provided in the text.