Vice President, Head of Global Patient Safety & Risk Management

POSITION OVERVIEW:

Disc Medicine is seeking a collaborative safety leader to develop and oversee the global pharmacovigilance (PV) and drug safety strategy for our advancing clinical pipeline in small molecules and mAbs. Reporting to the Chief Medical Officer, you will lead and execute the safety strategy, direct all pre- and post-marketing safety operations, ensure global regulatory compliance, and work cross-functionally with key stakeholders to foster a culture of safety as we transition into a late-stage and commercial biotherapeutics organization.

RESPONSIBILITIES:

Drug Safety Strategy & Safety Leadership – 50%

• Represent the safety function as an SME and strategic partner to executive leadership, key stakeholders, and development and filing teams.
• Collaborate closely with cross-functional partners to integrate the patient safety & risk management function across development programs.
• Develop and execute safety governance and surveillance processes and procedures
• Proactively lead medical safety and risk management oversight across the portfolio, including safety signal surveillance, benefit-risk assessments, and risk mitigation strategies.
• Serve as patient safety and risk management SME in development of key clinical trial and regulatory submission documents (e.g IBs, protocols, Integrated Summary of Safety, Risk Management Plans (RMPs), Safety Surveillance Plans, Reference Safety Information, CCDS/PIs)
• Oversee commercial safety monitoring strategies and product launch readiness.
• Serve as the chair of safety governance committee(s) and represent patient safety and risk management in Data Monitoring Committees and other key governance forums.
• Oversee medical review and submission of ICSRs
• Lead responses to safety questions from regulatory authorities and represent safety in regulatory interactions
• Review as SME safety data in public presentations and publications.

PV Operations & Compliance Oversight -30%

• Oversee the operations and compliance team responsible for PV vendor oversight, operational process development, safety systems, database reconciliation, inspection readiness, and regulatory submission activities.
• Ensure timely submission of expedited reports, DSURs, PBRERs, and other regulatory safety deliverables.
• Serve as the primary safety representative during inspections and audits and ensure corrective actions are effectively implemented.
• Develop efficient, scalable, and compliant patient safety and risk management processes and procedures in collaboration with the PV operations and compliance teams
• Ensure compliance with FDA, EMA, ICH, and global pharmacovigilance requirements.

Organizational Development & Business Management ~20%

• Build, mentor, and scale a high-performing patient safety & risk management organization, fostering a culture of safety, compliance, and operational excellence.
• Develop departmental operating plans, budgets, and resource strategies.
• Manage performance, priorities, and resource allocation to support pipeline progression and commercialization readiness.
• Manage and oversee internal and external PV resources, including safety functional service providers and consultants.

REQUIREMENTS:

• MD preferred, but highly effective leaders with PharmD, PhD (or equivalent advanced sciences degree) backgrounds encouraged to apply.
• Minimum of 15 - 20 years of progressive drug safety & pharmacovigilance experience in the biotechnology or pharmaceutical industry, with at least 5 years in leadership or management capacity.
• Deep expertise in safety surveillance, signal and risk management, benefit-risk assessment, global safety reporting requirements, and safety aggregate reports across all phases of clinical development.
• Comprehensive mastery of FDA, EMA, GVP, and ICH regulations and guidelines. Demonstrated experience supporting successful regulatory submissions including NDA, BLA and/or MAA filings and global health authority interactions.