Senior Medical Director - Nephrology (...

Position SummaryApply (by clicking the relevant button) after checking through all the related job information below. Client is seeking an experiencedSenior Medical Directorspecializing inNephrology , with a strong background inHematology , to join their Pharmacovigilance (PV) team. This leadership role will oversee strategic PV initiatives, provide clinical and safety expertise across the drug development lifecycle, and serve as a primary liaison between PV physicians, clients, and cross-functional teams. This position requires a seasoned medical professional with demonstrated success in risk management, regulatory compliance, team leadership, and complex therapeutic areas, particularlythrombotic microangiopathy (TMA)andpost-hematopoietic stem cell transplantcare. Key Responsibilities Provide global medical leadership to the PV physician team, including direct line management and mentoring of physicians. Lead strategic safety and risk mitigation initiatives throughout the drug development lifecycle. Serve as the primary clinical contact for clients and cross-functional teams; offer medical consultation and direction. Oversee the review and analysis of clinical trial serious adverse events (SAEs), aggregate reports, and regulatory submissions (e.g., PBRER, PSUR, DSUR). Drive process improvement, compliance strategies, and innovation across PV functions. Contribute to business development efforts including proposal writing, client presentations, and bid defense meetings. Participate in study start-up planning and ensure medical deliverables align with project scopes. Represent the PV function in audits, inspections, and regulatory interactions. Manage budgets, staffing plans, training programs, and resource allocation. Required Qualifications Medical Degree (MD)with significant experience inHematology , especially with: Thrombotic Microangiopathy (TMA) Post-Bone Marrow or Hematopoietic Stem Cell Transplant At least15+ yearsof relevant experience in clinical development, pharmacovigilance, or related fields. 8+ yearsin a leadership or management role overseeing medical or PV teams. Minimum1-2 research publications . Experience withlate-stage submissionsis highly preferred. Technical Skills & Expertise In-depth understanding of PV processes, global safety regulations (FDA, EMA), and clinical trial safety data interpretation. Expertise in safety signal detection, risk assessment, and aggregate safety reporting. Strategic leadership in multidisciplinary teams and cross-functional collaboration. Familiarity with regulatory submission requirements (e.g., CTD modules, REMS, RMP). Strong command of medical safety review, protocol interpretation, and benefit-risk analysis. Advanced decision-making, negotiation, communication, and mentorship skills. Ability to manage high-level client interactions and internal teams under tight timelines. Preferred Attributes Proven ability to lead global PV teams and deliver high-quality outcomes. Experience handling audits and inspections as a subject matter expert. Flexible to travel domestically and internationally as needed. Ability to work independently in a dynamic, fast-paced environment.

Created: 2025-06-04