Vice President, Head of Global Patient Safety & Risk Management

Disc Medicine•Massachusetts - Hybrid, MA

23h•$322,000 - $455,000•Hybrid

About The Position

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. Disc Medicine is hiring a new Vice President, Head of Global Patient Safety & Risk Management due to the fast growth of the company’s portfolio. The successful candidate will serve as the Vice President, Head of Global Patient Safety & Risk Management. Reporting to the Head of Clinical Development, this position will have visibility to the development teams and executive leadership with meaningful opportunities for professional development and career growth.

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.

Responsibilities

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.
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.
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.