Director, Medical Safety

Insmed Incorporated•NJ Corporate Headquarters, NJ

3d•$185,000 - $252,500•Remote

About The Position

Insmed is seeking a Director, Medical Safety for its Drug Safety & Pharmacovigilance team. Reporting to the Executive Director, DSPV Medical Safety, this role leads and develops a team of Pharmacovigilance Scientists responsible for signal detection, risk management, aggregate safety reporting, and clinical-trial safety support. The Director ensures high-quality safety surveillance throughout the product lifecycle and compliance with global pharmacovigilance regulations and company procedures. The Director serves as a strategic partner to Medical Safety Physicians and cross-functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance. The role provides scientific oversight of safety activities, supports benefit-risk assessments and regulatory interactions, and leads evaluation and implementation of AI-enabled tools and other process improvements in pharmacovigilance. This is a fully remote role that may be performed from anywhere while staying connected to the Insmed team and community. Occasional travel for team meetings or events is expected, with travel of up to 15%.

Requirements

Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline.
10 years of experience in the pharmaceutical or biotechnology industry.
At least 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.
Strong understanding of benefit-risk assessment methodologies.
Experience authoring and managing Risk Management Plans (RMPs), aRMM, and REM.
Significant experience preparing and overseeing aggregate safety reports, including DSURs, PSURs/PBRERs, and Annual Reports.
Experience supporting clinical studies throughout the product development lifecycle.
Thorough knowledge of ICH guidelines, FDA and EMA requirements, and global pharmacovigilance regulations.
Strong leadership, scientific, analytical, strategic-thinking, and project-management skills.
Ability to influence cross-functional stakeholders and PV senior leadership; ability to manage multiple priorities in a fast-paced environment.
Commitment to quality, compliance, and continuous improvement; excellent written and verbal communication skills.
Strong understanding of AI, automation, and advanced analytics in pharmacovigilance and drug safety, with demonstrated ability to evaluate and implement technology that improves efficiency, data quality, and regulatory compliance.

Nice To Haves

Advanced scientific degree.
Experience in pulmonary disease, rare diseases, or 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.
Experience with safety databases such as Argus or ARISg and safety analytics tools is preferred.

Responsibilities

Lead, mentor, and develop a team of PV Scientists; allocate resources across products and development programs to ensure timely delivery of safety work.
Foster scientific excellence, collaboration, continuous improvement, and regulatory compliance.
Oversee routine and ad hoc signal detection for investigational and marketed products; ensure emerging safety signals are identified, evaluated, documented, and communicated in a timely manner.
Review and approve signal evaluations and support safety governance activities.
Lead preparation, maintenance, and lifecycle management of core Risk Management Plans and associated safety documents; support implementation and evaluation of risk minimization measures.
Ensure consistency among Risk Management Plans, Core Safety Information, Investigator's Brochures, and product labeling.
Oversee the 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, partnering with Medical Safety Physicians on consistent medical and scientific evaluation of safety data.
Collaborate with Regulatory Affairs on 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 and external audits; work with Quality Assurance on inspections, audits, CAPAs, and compliance initiatives.
Lead evaluation, implementation, and ongoing 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.

Benefits

Comprehensive medical, dental, and vision coverage.
Mental health support and access to an Employee Assistance Program (EAP).
Annual wellbeing reimbursement.
Generous paid time off policies.
Fertility and family-forming benefits.
Caregiver support.
Flexible work schedules with purposeful in-person collaboration.
401(k) plan with a competitive company match.
Annual equity awards.
Employee Stock Purchase Plan (ESPP).
Company-paid life and disability insurance.
Company Learning Institute with LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities.
Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back. Eligibility for specific programs may vary and is subject to plan terms and conditions.