Director, Medical Safety at Insmed Incorporated in NJ Corporate Headquarters

Job description

• We’re looking for a Director, Medical Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll oversee a team of Pharmacovigilance (PV) Scientists responsible for signal detection, risk management, aggregate safety reporting, and clinical trial safety support and ensure the delivery of high-quality safety surveillance activities throughout the product lifecycle while maintaining compliance with global pharmacovigilance regulations and company procedures. You will also serve as a strategic partner to Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance to ensure timely identification, assessment, and communication of product safety risks.

Responsibilities

• In this role, you’ll have the opportunity to lead, mentor, and develop a team of PV Scientists. You’ll also:
• Allocate resources across products and development programs to ensure timely execution of safety deliverables. Foster a culture of scientific excellence, collaboration, continuous improvement, and regulatory compliance.
• Provide scientific oversight of routine and ad hoc signal detection activities for investigational and marketed products. Ensure timely identification, evaluation, documentation, and communication of emerging safety signals. Review and approve signal evaluations and support safety governance activities.
• Lead the preparation, maintenance, and lifecycle management of core Risk Management Plans (RMPs) and associated safety documents. Support implementation and evaluation of risk minimization measures.
• Ensure consistency between RMPs, Core Safety Information, Investigator's Brochures, and product labeling.
• Oversee preparation and scientific quality of aggregate safety reports
• Provide strategic guidance on benefit-risk assessments and safety conclusions.
• Provide pharmacovigilance support to clinical development programs from First-in-Human through post-marketing. Partner with Medical Safety Physicians to ensure consistent medical and scientific evaluation of safety data. Collaborate with Regulatory Affairs to support regulatory submissions and responses.
• Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, ICH, and other applicable health authority requirements. Support regulatory inspections and internal/external audits. Interface with Quality Assurance regarding inspections, audits, CAPAs, and compliance initiatives.
• Lead the evaluation, implementation, and continuous optimization of AI-enabled tools for signal detection, aggregate reporting, literature surveillance, case review, and other pharmacovigilance activities. Identify opportunities to streamline workflows, improve data quality, and increase operational productivity while maintaining regulatory compliance and scientific integrity.

Requirements

• You have a Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline along with 10 years of experience in within the pharma/biotech industry as well as minimum of 5 years of direct people management experience leading PV Scientists or Medical Safety professionals
• Demonstrated experience supporting both clinical development and post-marketing pharmacovigilance activities
• Extensive experience in signal detection and signal management. Experience with safety databases (e.g., Argus, ARISg) and safety analytics tools is preferred.
• Strong understanding of benefit-risk assessment methodologies. Exceptional experience authoring and managing Risk Management Plans (RMPs), aRMM and REM.
• Significant experience preparing and overseeing aggregate safety reports (DSURs, PSURs/PBRERs, Annual Reports).
• Experience supporting clinical studies throughout the product development lifecycle.
• Thorough knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulations
• Excellent leadership with strong scientific and analytical skills. Strategic thinker with strong project management skills.
• Ability to influence cross-functional stakeholders and PV senior leadership. Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.
• Demonstrated commitment to quality, compliance, and continuous improvement exceptional written and verbal communication skills
• Strong understanding of AI, automation, and advanced analytics applications within pharmacovigilance and drug safety. Proven ability to evaluate and implement innovative technologies that improve operational efficiency, data quality, and regulatory compliance.
• Advanced scientific degree
• Experience in pulmonary disease, rare diseases and gene therapy
• Experience participating in regulatory inspections and audits
• Experience leading global pharmacovigilance initiatives
• Familiarity with safety data visualization and signal detection methodologies
• Experience working in a matrixed global organization

Skills

Required

• Signal detection and signal management
• Benefit-risk assessment methodologies
• Leadership
• Scientific and analytical skills
• Strategic thinking
• Project management
• Influence cross-functional stakeholders
• Detail-oriented
• Written and verbal communication

Benefits

• At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
• Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
• $185,000.00-252,500.00 Annual