Senior Director, US Risk Management & Product Safety (REMS)

About the role

Novartis is looking for a Senior Director, US Risk Management & Product Safety (REMS) in East Hanover, NJ, in a hybrid role. You will lead the US safety strategy for a portfolio of complex, high-profile medicines, overseeing REMS design, product safety governance, FDA engagement and risk management execution. Relocation support is not offered.

Key responsibilities

• Lead the US REMS safety strategy, aligned with FDA requirements, global risk management plans and patient safety priorities
• Drive development, approval and launch of REMS programs such as restricted distribution, prescriber/pharmacy certification and patient enrollment systems
• Provide US input into Risk Management Plans (RMPs) and REMS assessments, and help optimize risk minimization measures
• Manage REMS vendors (call centers, specialty pharmacies, prescriber certification platforms) for compliance, quality training and data integrity
• Oversee US safety-related labeling (USPI, Medication Guides, REMS safety language) and timely submission of aggregate reports such as PADERs and PBRERs
• Serve as primary contact for US product safety inquiries, escalations and Health Authority requests
• Maintain readiness for inspections and audits, manage findings, corrective actions and CAPAs, and stay current with regulatory requirements
• Take part in FDA interactions, REMS negotiations, advisory boards and industry forums

Required profile

• Bachelor's degree in Health Care or Life Sciences required; advanced degree (PharmD, PhD or MD) preferred
• 10+ years of PV leadership experience, including risk management planning and operational execution
• Minimum of 8 years of pharmaceutical industry experience
• Proven leadership, communication, influencing and decision-making capability, with strong executive presence

Required skills

• Strong knowledge of FDA REMS requirements, US pharmacovigilance regulations and audit/inspection management
• Deep understanding of risk management principles and REMS implementation
• Desirable: familiarity with safety databases, REMS platforms and data analytics tools

What we offer

• Expected salary range of $204,400 to $379,600 per year, depending on skills and experience
• Performance-based cash incentive and eligibility for annual equity awards
• Benefits for US-based eligible employees: health, life and disability coverage, 401(k) with company match and generous time off