Director, Safety Scientist Lead – Rare Disease

Regeneron

. Serve as the first point of contact for Rare Disease operations, including safety data processing, submission creation, and documentation .

Posted 11/6/2026full-timeTarrytown • New York • United StatesSenior💰 $205,000 - $341,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and safety operations, with a strong focus on signal detection, compliance, and quality management. Proven leadership in developing high-performing teams and optimizing processes within Rare Disease contexts.

Highest-signal resume keywords

Pharmacovigilance ExperienceSafety Operations ManagementSignal Detection CoordinationLeadership DevelopmentCompliance and Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Data ProcessingSubmission CreationAggregate ReportingSignal ManagementData AnalysisBenefit-Risk AssessmentSOP DevelopmentTraining Program ImplementationProject ManagementAttention to Detail

Soft Skills

Strong Leadership CapabilitiesInterpersonal CommunicationOrganizational SkillsWorkload PlanningVerbal and Written Communication

Tools & Technologies

AI TechnologiesMonitoring ToolsKnowledge-Management Resources

Industry Keywords

Rare DiseaseSafety SciencesPharmacovigilanceGlobal Patient SafetyCompliance

About the role

Key responsibilities & impact

Serve as the first point of contact for Rare Disease operations, including safety data processing, submission creation, and documentation
Ensure completeness, accuracy, and timeliness of safety operations
Lead compliant execution of safety surveillance, signal management, and aggregate reporting across the portfolio
Develop and manage a team of Safety Scientists
Work with other Directors to standardize and ensure consistency in signal detection activities
Develop common practices, processes, and templates for signal detection and safety-document authoring across products and therapeutic areas
Ensure compliance and quality management of Safety Sciences Delivery activities
Establish SOPs and associated monitoring tools
Lead signal detection coordination and signal management across Rare Disease, including SMT, SSP, and SER processes
Develop innovative approaches integrating new technologies
Analyze aggregate safety data to identify emerging safety issues and patterns
Coordinate cross-functional delivery of benefit-risk assessments for periodic safety reports, including DSURs and PSURs
Support GPS portfolio documents such as ARM, RMP, and SMP with Medical and Safety perspectives
Develop and implement GPS staff training programs and maintain training, proficiency, and knowledge-management resources
Liaise with Safety Sciences Strategy Rare Disease GPS Leads
Collaborate with Clinical, Regulatory, Medical Affairs, Biostatistics, and Data Management interfaces
Build, coach, and scale a high-performing team
Drive succession planning, talent pipelines, talent strategy, and leadership development initiatives

Requirements

What you’ll need

Advanced Degree required in life sciences or healthcare
12+ years of pharmacovigilance (PV) experience
Preferably focused on Safety Sciences and Rare Disease experience
Strong attention to detail
Ability to assess and optimize Safety operations processes
Ability to drive consistency and ensure high-quality, compliant execution across activities
Strong leadership capabilities and presence
Strong interpersonal, verbal, and written communication skills
Organizational and workload planning skills
Ability to manage multiple projects simultaneously
Preferred experience with oversight of operations within a global patient safety organization
Preferred experience with AI technologies
Preferred experience leading a matrixed role across multiple organizational areas
Preferred people management experience
25% travel may be required

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required