Summit Therapeutics
Director, Safety Physician
Remote (US) · Director
Sponsorship not specifiedDetected 41 days ago
ICD-10Clinical TrialsPharmacovigilanceCollaboration
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Reporting to the Vice President, Patient Safety & Pharmacovigilance (PSPV), the Director, Safety Physician is responsible for pharmacovigilance activities for investigational and marketed products.
- The role also provides safety-related medical input and guidance across the organization, as requested by the VP of PSPV.
Responsibilities
- Prepare Analyses of Similar Events (AOSEs) to support IND safety reports.
- Lead or actively contribute to the preparation and presentation of safety information for the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal or external stakeholders, as needed.
- Review individual and aggregate safety data from the safety database on a scheduled basis to support signal detection.
- Serve as product lead and/or therapeutic area lead, as assigned.
- Implement appropriate case follow-up and query activities in accordance with applicable SOPs.
- Support reconciliation activities between Safety and Clinical databases.
- Develop, maintain, update, review, and approve the list of expected terms in the Reference Safety Information (RSI) within the Investigator's Brochure, in collaboration with development partners and cross-functional teams.
Nice to have
- Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
- Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology.
- Summit has multiple global Phase 3 clinical studies, including:
- Non-small Cell Lung Cancer (NSCLC)
- Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
- Colorectal Cancer (CRC)
- Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Benefits
- Lead the medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments, to ensure high-quality and medically accurate reports.
- Interact and liaise with pharmacovigilance vendor medical reviewers and company Medical Monitors.
- Identify and communicate ICSR case quality issues to PV Operations, as appropriate, and support quality assurance activities related to ICSR medical review.
- Develop and support medical coding conventions and systematic process improvements for ICSR medical review.
- Serve as a Medical Safety Review process lead, and support the development, training, and implementation of new Medical Safety Review processes.
- Mentor Safety Physicians / Medical Safety Reviewers, as needed, and provide direct management of Safety Physicians / Medical Safety Reviewers when assigned.
- Maintain inspection readiness and serve as the functional representative and point of contact for health authority inspections and internal process audits within the scope of the role.
Company info
- Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.