Vice President, Head of Global Patient Safety & Risk Management

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.  COMPANY OVERVIEW: 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.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,...