Day One Biopharmaceuticals is hiring a
Medical Director

Summary

The job is for a Medical Director with expertise in safety data management and safety databases, responsible for providing medical leadership and oversight to ensure the accurate and efficient analysis of safety data, identification of potential safety signals, and compliance with regulatory requirements. The position reports to the Vice President, Pharmacovigilance and Patient Safety and can be fully remote.

Requirements

• Medical Degree (e.g., MD, MBBS, DO) required
• 5+ years' experience as an Industry Medical Safety Physician or similar experience with safety oversight activities related to industry clinical trials via a CRO or academic center running industry trials

Responsibilities

• Provides medical expertise in the analysis of safety data from clinical trials and post-marketing sources
• Participates in the medical review of case narratives for medical content, accuracy, and signal detection
• Helps oversee the management of safety databases (e.g., Argus, Rx Logic) and ensure accurate and timely entry of safety data
• Participates in data analysis and serves as a co-author for periodic reports (e.g., DSURs, PSURs, etc.) and other regulatory documents related to safety
• Identifies and manages potential safety signals, including evaluation and risk assessment and participates in benefit-risk analysis for all assigned compounds
• Collaborates with cross-functional teams, including Clinical Development, Regulatory Affairs, and Safety Operations
• Ensures compliance with global regulatory requirements and company procedures for pharmacovigilance
• Participates in the analysis of the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict/establish the safety profile of compounds in clinical development
• Provides medical input on safety-related issues and contributes to the development of safety strategies
• May participate in safety data to Data Monitoring Committees or assigned products and internal Safety Assessment Committees
• Participates in cross-functional project teams including Clinical Trial Study Teams; communicates across organizational levels and functions
• Participates in SOP updates, audits, and inspection readiness
• Participates in authoring/updates of core safety information for assigned projects in collaboration with Safety Operations
• Supports preparation for external meetings with Health Authorities
• May participate/present safety material to Company and Investigator's meetings and other medical meetings
• Willing to participate in workshops and trainings to build skills and knowledge of drug development in pediatric and rare disease
• Oversight of contract team members and projects as necessary

Benefits

The salary range for this position is $250,000 - $265,000