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RayzeBio Safety MD Senior Director

Bristol Myers Squibb · Princeton, NJ · Today
Business Development$307k–$372k/yrFull-time

Safety MD Role Overview

The Safety MD role for RayzeBio will provide medical safety leadership across clinical development and pharmacovigilance activities, with a strong focus on proactive safety surveillance, signal detection, risk management, and benefit-risk assessment. The role will partner closely with clinical, regulatory, medical affairs, and safety teams to support product development, regulatory submissions, health authority interactions, and safety governance.

Responsibilities

  • Lead or co-lead global pharmacovigilance strategy, proactive safety surveillance, signal detection, risk management, and compliance with FDA, EMA, ICH, and other applicable regulations.

  • Establish and maintain safety governance structures, SOPs, and continuous improvement processes aligned with company objectives and industry best practices.

  • Partner with BMS safety, clinical development, regulatory, medical affairs, and cross-functional teams to integrate safety insights into product development, clinical trials, labeling, and risk minimization strategies.

  • Direct safety evaluation and benefit-risk assessment for clinical development and post-marketing products, including AE profile management and product safety strategy.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Drive safety-related content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to regulatory inquiries.

  • Perform daily ICSR/SAE case reviews and support appropriate safety management across all phases of clinical trials.

  • Serve as a key PV representative for global regulatory authorities, external experts, scientific bodies, and industry groups while advocating for patient safety.

  • Mentor cross-functional colleagues, direct reports, and safety team members on core PV concepts and practices.

  • Leverage AI to improve program, portfolio, or functional performance through prioritization and scaled adoption.

  • Drive safety-related content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to regulatory inquiries.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Drive safety-related content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to regulatory inquiries.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

  • Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.

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