Lead safety for oncology pipeline. $260-320K. No call. No weekends. No nights.
Join Zentalis as a Safety Medical Director in San Diego, California.
Key Responsibilities
- Lead signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information.
- Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings.
- Oversee Medical safety review including causality assessment of all available safety data generated from various sources (e. g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
- Provides medical expert safety review input into all critical documents for products in clinical development (e. g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)).
Requirements
- Identification and management of Urgent Safety Measures with support of cross functional team.
- Overview, and/or author aggregate reports and signal evaluation reports for assigned projects.
- Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
Benefits & Compensation
Work Schedule
This position offers competitive compensation. Work with Zentalis in San Diego, California.
Qualifications
- Education
- Doctoral or professional degree (postgraduate degree)
- Experience
- 10+ years of experience
Key Skills
Signal DetectionPharmacovigilanceRisk ManagementMedical Safety ReviewCausality AssessmentRegulatory SubmissionsICSR ReviewVendor OversightClinical DevelopmentDrug SafetyScientific AnalysisCross-functional Collaboration
