Regeneron

Director

• Lead model-informed drug development strategies across therapeutic areas and modalities including antibodies, siRNA, and gene therapies
• Inform dose selection, trial design, and regulatory strategy from early development through submission
• Drive model-informed development and pharmacometrics strategies with Clinical Pharmacology, Biostatistics, Clinical, and Translational teams
• Lead Quantitative Pharmacology evaluation of assets
• Deliver population PK/PD, exposure–response, and translational modeling analyses
• Represent Quantitative Pharmacology at program and governance meetings
• Communicate quantitative insights to non-modeling audiences
• Contribute to regulatory interactions and author Quantitative Pharmacology components of regulatory documents
• Mentor and develop junior scientists
• Identify and implement process improvements, new modeling approaches, and quantitative tools
• Ensure analyses and documentation meet scientific quality and regulatory compliance standards

Associate Director – Quantitative Pharmacology

Learning and Development

• Collaborates with stakeholders to gather business requirements and develop category strategies for strategic sourcing initiatives
• Analyzes data and market trends to inform procurement strategies and business case development
• Negotiates with suppliers to secure favorable terms and supports supplier performance management
• Partners with international colleagues on global procurement efforts and process and system improvement projects
• Assists in developing strategies to deliver goods and services aligned with Regeneron's business objectives
• Supports supplier selection processes, including evaluation and contract drafting
• Rotates through at least three procurement roles across Global Category Teams, the Center of Excellence, and International Markets
• Builds procurement expertise through hands-on, cross-functional experience with guidance from a dedicated program lead

Global Procurement Associate – Leadership Development Rotational Program

Clinical Specialist

• Provide technical and administrative support to clinical study teams executing trials across a program
• Help ensure studies stay on track from site activation through close-out
• Collaborate with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites
• Organize and deliver analyzable reports and metrics
• Coordinate study team meetings, agendas, and minutes
• Collate data for feasibility and site selection assessments
• Contribute to review of study documents and reference materials
• Track site activation, enrollment, and monitoring visits against projected plans
• Escalate issues or delays and monitor investigator/site status and registry postings
• Ensure timely receipt of scheduled reports and perform TMF reconciliations with study lead guidance
• Communicate with sites as directed and maintain site contact information and relationships
• Contribute to close-out activities and support oversight of third-party vendors
• Investigate the impact of new information on assigned study activities and trials
• Participate in SOP revisions and departmental initiatives
• Recommend process improvements

Clinical Study Specialist

General

• Develop strategy and execute tactics within key accounts in Allergy/Immunology and ENT therapeutic areas to generate product utilization
• Establish and foster working relationships with Allergy/Immunology/Otolaryngology healthcare professionals and key patient advocacy support groups
• Collaborate with regional colleagues and field-based and home office personnel to address customer needs
• Analyze market dynamics and trends to develop strategies supporting brand and corporate objectives
• Participate in industry-related congresses, local and regional meetings, and medical conferences

Medical Specialist I – Allergy/ENT

• Establish and maintain procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards
• Collaborate with the Process and Procedures team and support the Process Owner Network
• Ensure PV Intelligence updates are assessed and reflected in GPS procedures
• Liaise with Process & Procedures and the Learning Centre of Excellence on procedural updates and training curriculum
• Validate procedures against safety practices and close gaps between documented processes and operational execution
• Develop, implement and maintain GPS procedures aligned with regulations, Regeneron Standards and industry best practices
• Lead assessment of evolving global PV regulations
• Set risk-based prioritization and sequencing for procedural updates
• Ensure procedural documents are assigned to relevant training curriculum
• Oversee GPS Planned Process Deviations and guide SMEs on GDQ approval criteria
• Coordinate PPD expiration dates with queued procedure projects
• Escalate and resolve internal process and quality-event alignment challenges
• Manage GPS procedure content and maintain the accuracy of PSMF Annex E
• Oversee CAPAs associated with procedures and ensure timely closure
• Provide metrics on CAPAs, process deviations and training compliance to GPS leadership
• Lead initiatives to improve GPS process effectiveness and efficiency
• Present performance findings and recommendations to leadership
• Liaise with Corporate and Clinical QA on GPS process and GXP-related impacts
• Represent Standards & Training in audits and inspections
• Serve as backup GPS Standards & Training liaison to the Learning Centre of Excellence

Associate Director, Global Patient Safety Standards – Training

• Serve as the first point of contact for all safety-related issues for assigned compounds/assets within a therapeutic area
• Represent Global Patient Safety on cross-functional Strategic Program Teams
• Lead safety strategy and ensure optimal support from Global Patient Safety
• Direct all Global Patient Safety activities for assigned compounds and products
• Support safety surveillance, signal management, safety-profile communication, benefit-risk assessment and regulatory safety responses
• Lead preparation and review of DSURs, PSURs, development RMPs, RMPs and clinical documents
• Lead cross-functional Safety Monitoring Team activities
• Represent Global Patient Safety on RSOC, IDMC, SPT and other internal and external teams
• Develop safety strategies and planning for non-compound-specific activities
• Provide medical review support for complex ICSRs and other data sources
• Participate in developing and maintaining SOPs, working practices and guides
• Participate in continuous improvement activities, cultivate cross-functional relationships and mentor junior safety scientists
• Serve as a subject matter expert for assigned compounds

Director, Global Patient Safety Sciences – General Medicine

• Serve as a domain pharmacovigilance expert on safety data, processes, and regulations across Global Patient Safety
• Define and own the PV systems forward-looking strategy, including technology systems, data architecture, and AI-enabled capabilities
• Partner with GD-IT and other technology teams on roadmap execution
• Define and communicate the function’s vision and strategy in alignment with enterprise goals
• Collaborate with GPS functional leads to develop an integrated roadmap
• Define requirements, priorities, and dependencies for the GPS roadmap as PV domain owner
• Maintain the GPS PV systems roadmap while balancing modernization, operational sustainability, and regulatory compliance
• Identify opportunities for AI and advanced analytics in PV processes and guide solution design, validation, and implementation
• Conduct first-pass review and prioritization of AI use cases for GPS with the enterprise AI Center of Excellence
• Oversee AI implementation, user adoption, compliance, and responsible use across GPS
• Ensure PV systems and ways of working meet GxP, validation, and data integrity requirements
• Translate business requirements into PV systems specifications
• Provide strategic oversight of safety databases, signal detection tools, and analytics platforms
• Serve as primary GPS liaison with enterprise technology partners
• Oversee system vendor performance, contract management, and PV systems modernization delivery
• Build, coach, and scale a high-performing team
• Lead talent strategy and leadership development initiatives
• Influence cross-functional leaders to align PV priorities and drive enterprise results

Executive Director, Pharmacovigilance Systems – Enablement

Account Specialist

• Engage healthcare professionals treating NSCLC/NMSC patients within assigned accounts
• Present clinically focused selling messages to grow brand share, revenue, and product goals
• Lead performance and deliver results compliantly and with integrity
• Collaborate with Reimbursement and Access Specialists and Key Account Managers to address customer needs
• Engage Oncology specialists and key experts within assigned account alignment
• Partner with Regional Directors, Territory-based Oncology Account Specialists, OKALs, and Reimbursement Specialists
• Proactively resolve customer needs and identify market dynamics and trends
• Develop strategies supporting brand and corporate objectives in the assigned territory
• Build strong working relationships with designated accounts and specialists
• Execute market profiling activities to understand regional and local healthcare delivery, influencers, and payer systems
• Identify business opportunities with assigned accounts
• Coordinate efforts of the Regeneron Oncology account team, including contracting pull-through support
• Develop relationships across accounts to understand objectives, goals, and challenges
• Identify approved Regeneron Oncology resources aligned with customer needs
• Maintain compliance in all customer interactions

Medical Account Specialist II – Oncology

Manager

• Forecast Investigational Product (IP) supply requirements for multiple clinical trials
• Manage IP distribution processes for one or more clinical trials
• Lead drug supply management and demand forecasting according to IOPS requirements
• Manage supply planning, timelines, inventory strategy, resupply activities, shipments, returns and destruction
• Develop and oversee expiry, ancillary and comparator supply strategies
• Develop specifications and support user testing of IVRS/IWRS systems
• Monitor clinical supply activities from study start-up through study closure
• Review and approve IP-related study documents, tools, kit lists and specifications
• Represent Clinical Drug Supply & Logistics on cross-functional study teams
• Coordinate training and communicate with CROs, vendors, investigator sites and study teams
• Act as point of escalation for IP-related and vendor-related issues
• Provide input into budgets, statements of work, contracts and timelines
• Create RFPs, review quotes and manage distribution vendor budgets
• Lead management of IP service vendors and oversee performance, quality, timelines, deliverables and costs
• Develop and implement process initiatives
• Track and report supply metrics and supply status to study teams and senior management
• Mentor or coach junior Clinical Drug Supply & Logistics staff; does not supervise staff

Temporary Manager – Clinical Drug Supply & Logistics

• Report to the Regional Director
• Develop and manage relationships with retina specialists and other customer accounts in the assigned territory
• Grow revenues and consistently deliver product goals
• Provide technical and clinical product knowledge and support
• Effectively utilize Regeneron marketing and operations resources to enhance productivity
• Provide optimal customer satisfaction
• Travel 40–60% within the assigned territory

Medical Specialist II, Ophthalmology

• Report to the Regional Director
• Develop and manage relationships with retina specialists and other customer accounts in the assigned territory
• Grow revenues and consistently deliver product goals
• Provide technical and clinical product knowledge and support
• Effectively utilize Regeneron marketing and operations resources to enhance productivity
• Provide optimal customer satisfaction

Medical Specialist II – Ophthalmology

Artificial Intelligence

• Lead a unified Data Management and Architecture function within Global Development IT
• Define strategy for data platforms, AI architecture, and data governance
• Ensure the technology landscape supports secure, scalable, and compliant data capabilities
• Partner with Enterprise Data & AI, Enterprise Architecture, Information Security, and Global Development leadership
• Own and lead the unified Data Management & Enablement function
• Integrate data engineering, analytics, data repository, data delivery, and architecture capabilities into a single team
• Drive data platforms and standards, including progress toward a validated centralized data repository
• Build and scale data engineering and analytics capability, including the India-based Global Capability Center team
• Serve as Global Development’s data and AI architecture authority
• Define architecture strategies for data platforms, pipelines, and solutions
• Provide domain-specific solution architecture aligned with Enterprise Architecture standards
• Define integration, API, and data exchange patterns
• Represent Global Development at the Architecture Review Board and present proposed investments
• Enforce data quality, lineage, classification, access, regulatory compliance, MDM, and data catalog standards
• Establish data stewardship accountability across Global Development data domains
• Coordinate cross-vertical architecture and Architecture Review Board participation
• Partner on end-to-end solution design and data security architecture
• Build and lead a combined data enablement, engineering, analytics, and architecture team
• Recruit, develop, mentor, and provide technical direction to talent
• Communicate architecture tradeoffs, platform investment needs, and technology implications to leadership
• Prepare executive-level materials for governance forums, steering committees, and senior leadership
• Build relationships with the Office of the CIO and surface technical debt and platform gaps

Executive Director, Data Management, Analytics, AI & Architecture

• Serve as the key interface between Global Patient Safety business leadership and Digital & Technology
• Orchestrate Digital & Technology capabilities to deliver Global Patient Safety objectives across Argus, PIVIT, Signal Management, aRMM/ARMM, and SRP
• Own and prioritize the multi-year platform strategy and roadmap
• Lead a team of Directors delivering governance and regulatory-compliant operations across the safety technology portfolio
• Define organizational structure, role allocation, and resourcing for the GPS Business Solution function
• Establish governance frameworks, standards, and validation practices
• Own budget, forecast, software licensing, services agreements, and vendor contract accountability
• Oversee planning, prioritization, execution, product backlog, incident management, and release governance
• Coach and develop Directors and Managers
• Manage steering committee meetings, working groups, and issue/release management
• Ensure platforms meet GxP validation, data integrity, audit-readiness, and global safety reporting standards
• Oversee case processing, signal detection, and risk management workflows
• Partner with Enterprise IT, Enterprise Architecture, Information Security, Regulatory Affairs, Quality, and platform vendors
• Represent GPS technology priorities in enterprise architecture and governance forums
• Engage senior GPS and IT leadership on complex or ambiguous issues
• Monitor drug safety technology and regulatory reporting trends
• Prepare and deliver executive-level materials on platform portfolio health and roadmap

Senior Director – Global Patient Safety Solutions Partner

Medical Director

• Engage in the exchange of scientific data and medical/scientific information with KOLs, HCPs, researchers, pharmacists and population-based decision makers
• Demonstrate thorough understanding of solid tumors, including cutaneous oncology, and other tumors of interest within clinical development and aligned with strategic medical plans
• Establish, foster, cultivate and maintain peer relationships with KOLs
• Act as the primary clinical/scientific resource to HCPs regarding disease state and company products
• Identify and maintain lists of relevant medical/therapeutic area experts and investigators, and develop engagement plans
• Support evidence generation through company-sponsored trials and investigator-initiated studies
• Identify and report medical insights
• Identify research gaps and educational needs to inform medical strategy
• Respond to information requests and present or discuss scientific and clinical data with appropriate audiences compliantly
• Perform disease management and therapeutic area education with practitioners, payers and researchers
• Attend medical conferences to collect and report scientific, clinical and competitive intelligence to internal partners
• Maintain company policies, procedures, principles and financial controls with integrity and professionalism

Associate Director, Medical Affairs, Cutaneous Oncology

Quality Specialist

• Serve as a technical resource and Subject Matter Expert for QC Microbiology laboratory operations, microbiological methods, and testing programs
• Evaluate, implement, and support new or revised microbiological methods, laboratory procedures, equipment, software applications, and reporting tools
• Lead and support laboratory studies, protocols, troubleshooting efforts, and technical assessments
• Represent QC Microbiology on cross-functional teams and project initiatives
• Lead and support complex laboratory investigations, deviations, non-conformances, and root cause analyses
• Perform data gathering, trend analysis, and technical assessments to support investigations and business decisions
• Initiate, execute, and close quality system records including Change Controls, CAPAs, deviations, and document revisions
• Ensure investigations and quality system activities comply with cGMP requirements, company procedures, and regulatory expectations
• Author, revise, and review SOPs, technical reports, protocols, risk assessments, and other controlled documents
• Facilitate inspection readiness activities and participate in internal audits, regulatory inspections, and client audits
• Monitor regulatory and technical updates and incorporate applicable changes into laboratory procedures and practices
• Ensure laboratory activities, documentation, and data integrity practices remain compliant with regulations and industry standards
• Monitor and analyze laboratory performance metrics and KPIs
• Identify and implement process improvements to enhance efficiency, compliance, data quality, and laboratory performance
• Support strategic initiatives improving microbiology testing, sampling programs, and laboratory operations
• Collaborate with internal stakeholders and external partners to resolve technical and operational challenges