Regeneron

General

• Drive global execution of site activation for clinical trials
• Develop site start-up strategies, identify dependencies, and mitigate or escalate risks
• Track and analyze study metrics, risks, mitigation strategies, and CRO performance
• Guide cross-functional teams on data-driven site selection strategies
• Develop, assess, and align site activation projections with cross-functional and CRO partners
• Maintain complete and compliant site start-up documentation in the Trial Master File (TMF)
• Develop global country start-up strategies and maintain country intelligence data
• Support regulatory submissions, including site documentation, CIRB/LIRB submissions, and CRO insurance requests
• Ensure timely country submission deliverables and effective communication pathways
• Lead fast-track site initiation, site calls, document collection, and milestone tracking
• Provide training and guidance on essential site documents, regulatory requirements, document management, and TMF filing
• Oversee CRO site start-up management or in-house regional SSU teams
• Collect and analyze site intelligence for site selection and start-up
• Oversee site regulatory package preparation and approval while maintaining inspection readiness
• Represent SSU on cross-functional teams, provide updates, escalate challenges, and propose mitigation strategies
• Serve as escalation point for CRO and internal teams
• Recommend and participate in cross-functional and departmental process improvements

Temp Global Site Start Up Lead

Operations

• Execute key operational aspects of complex early- and late-phase clinical trials supporting the general medicine portfolio
• Collaborate with Clinical Imaging Science Leads and clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with study-specific imaging procedures
• Collaborate with imaging vendors, clinical operations, data management, CROs, and clinical sites throughout study startup, execution, and closeout
• Manage imaging startup activities, including vendor selection, requests for proposals, and timeline management
• Oversee external imaging vendors at the study level
• Author, review, and manage Imaging Manuals, Independent Review Charters, communication plans, data transmittal forms, SOPs, and Work Instructions
• Ensure documentation is audit-ready and properly filed in the Trial Master File
• Provide technical support and training to clinical site personnel, including site initiation visits or teleconferences
• Review and approve training materials for imaging facilities and clinical site personnel
• Track imaging progress, resolve issues, monitor imaging performance indicators, support query resolution, and troubleshoot timeliness and quality concerns

Associate Manager, Clinical Imaging Operations

Project Manager

• Manage highly complex facilities engineering design and construction projects
• Oversee renovations, repurposing of existing spaces, new equipment installations, and new building construction
• Identify and address project lifecycle issues to minimize cost and schedule impacts
• Conduct preliminary surveys and prepare schematic, preliminary, and work drawings
• Estimate project costs, write contracts and specifications, and secure contractor bids
• Evaluate contract document changes and ensure authorized changes are implemented
• Consult with architects, engineers, owners, and contractors on layouts, construction procedures, and code requirements
• Manage project cost, schedule, and scope
• Coordinate projects with departments to minimize operational risk and impact
• Compile documents for turnover of new or renovated spaces and equipment
• Support equipment qualification and execute new equipment commissioning
• Enter new area and equipment data into quality systems and databases
• Coordinate specialized training for new systems and equipment
• Analyze project feasibility and design requirements
• Inspect existing facilities and prepare condition, deficiency, repair design, and repair cost reports
• Design, prepare, and review construction project plans
• Provide recommendations on growth direction with supporting justification
• Mentor junior and mid-level staff and manage contractor teams
• Implement work in compliance with safety, site cleanliness, and cGMP requirements

Principal Project Manager, Facilities Engineering

Director

• Oversee development and execution of biomarker strategies for novel cell therapies, cell transfer conditioning agents and combinations with bispecific antibodies across Oncology and Immunology
• Design, develop, communicate and operationally implement clinical biomarker strategies for early- and late-stage drug development programs
• Develop and implement pharmacokinetic, mechanism-of-action, patient-stratification and pharmacodynamic clinical biomarker assays
• Collaborate with internal teams, Regeneron groups and contract research organizations to develop and implement clinical biomarker assays
• Develop and implement strategic visions for pharmacokinetic, pharmacodynamic and exploratory biomarkers for clinical studies
• Collaborate with Biomarker and Clinical Operations teams on biomarker and exploratory sample collection and analyses
• Represent Precision Medicine on development and cell therapy characterization teams
• Integrate, influence and deliver biomarker strategies from concept through execution, data delivery and results interpretation
• Collaborate with internal laboratories and groups to plan assay validation and clinical application
• Ensure complex clinical assays are fit-for-purpose
• Facilitate incorporation of Precision Medicine biomarker strategies from discovery through clinical development
• Represent Regeneron externally through collaborations and presentations
• Contribute to clinical protocols, schedules of assessments, clinical study reports, technical reports, data agreements and scientific publications
• Make recommendations to development teams and management

Associate Director, Precision Medicine – Cell Medicine

Manager

• Oversee day-to-day operations of U.S. employee benefits programs, including health plans and additional benefits
• Ensure timely enrollment, compliance, and accurate processing of benefits transactions
• Serve as the escalation point for complex benefits issues and inquiries
• Lead, mentor, and manage a team of benefits specialists
• Provide coaching, training, and professional development opportunities
• Foster a positive, inclusive team environment encouraging collaboration, innovation, and continuous improvement
• Ensure compliance with federal, state, and local regulations, including ACA, ERISA, COBRA, and HIPAA
• Oversee preparation and submission of required regulatory reports
• Monitor changing laws and advise leadership; update policies and procedures with stakeholders
• Manage benefits vendor and third-party administrator relationships
• Negotiate contracts, monitor service levels, and evaluate vendor performance
• Collaborate with HR leadership to design and implement benefits strategies
• Analyze data and trends to identify cost-saving and program-enhancement opportunities
• Develop benefits communication materials and organize informational sessions, workshops, and open enrollment events
• Address employee benefits inquiries directly
• Collaborate with the Law Department and partner with the HR service center
• Report to the Director Benefits

Senior Manager, Benefits

Business Operations

• Track and manage compliance across a portfolio of 155+ global data licensing collaborations involving genetic and associated health data
• Monitor ongoing compliance, conduct risk assessment, and oversee remediation
• Oversee development and operationalization of RGC data governance policies, procedures, consent frameworks, and data use agreements
• Collaborate with the Privacy Office on privacy impact assessments and other regulatory requirements
• Lead, mentor, and develop a team of data governance and compliance professionals
• Foster accountability, transparency, and continuous learning
• Collaborate with Legal, the Privacy Office, IT Security, Research, and Business Development
• Embed privacy-by-design into data collaboration workflows and new initiatives
• Oversee data governance, collaboration finance, strategic vendor contracting, and Confidential Disclosure Agreement processing
• Track and monitor research, business, and finance deliverables
• Maintain compliance and report portfolio status to leadership
• Oversee several headcount directly and indirectly

Director, Strategic Partnerships – Business Operations

• Lead model-informed drug development strategies supporting therapeutic areas across antibodies, siRNA, and gene therapies
• Inform dose selection, trial design, and regulatory strategy from early development through submission
• Provide significant Pharmacometrics contributions for research and development programs
• Contribute to strategic program development and communicate complex Pharmacometrics strategies and results to development teams
• Design, conduct, or oversee PMx analysis plans
• Apply standardized or advanced scientific techniques to conduct PK, PD, and other quantitative analyses
• Prepare and timely deliver accurate nonclinical or clinical study reports and regulatory submission documents

Associate Director – Quantitative Pharmacology

• Support Cost Management Leads with budget-related activities, from building budgets to managing budgets
• Work with CTM, CDSL, Procurement, Finance, functional groups, and other Business Operations staff on departmental tasks
• Gather and analyze departmental metrics data for budget development, variance reporting, tool development, budget dashboards, and metrics reporting
• Support financial budget modeling for Cost Management scope of work
• Follow established Regeneron processes for Business Operations Cost Management responsibilities
• Assist with developing procedures and tools for Cost Management functions
• Compile and maintain regular data and reports of Cost Management activities and processes
• Apply company policies and standard practices to resolve issues
• Help define or enhance escalation pathways
• Participate in process improvement initiatives for the Cost Management group
• Support Business Operations with various department deliverables

Business Operations Specialist

Medical Director

• Develop and oversee Global & US medical strategy and tactics for a key asset, including publications, field communications, and expert collaborations
• Apply deep therapeutic expertise to address current and future medical needs in clinical practice
• Lead generation and dissemination of clinical and non-clinical data supporting the medical strategy
• Partner across a cross-functional Medical Product Team, R&D, commercial, and access & reimbursement to drive alignment
• Cultivate long-term strategic relationships with clinical experts, societies, advocacy groups, and alliance partners
• Co-lead formation and execution of Phase 3b/4 plans where applicable
• Champion high standards of compliance, ethics, and patient safety across all medical activities
• Oversee medical review of promotional materials and training content for scientific accuracy

Medical Director, Medical Affairs, Dermatology

• Develop and oversee U.S. medical strategy and tactics for a key asset, including publications, field communications, and expert collaborations
• Apply therapeutic expertise to address current and future medical needs in clinical practice
• Lead generation and dissemination of clinical and non-clinical data supporting the medical strategy
• Partner with Medical Product Team, R&D, commercial, and access and reimbursement teams to drive alignment
• Cultivate strategic relationships with clinical experts, societies, advocacy groups, and alliance partners
• Co-lead formation and execution of Phase 3b/4 plans where applicable
• Champion compliance, ethics, and patient safety across medical activities
• Oversee medical review of promotional materials and training content for scientific accuracy

Medical Director – Medical Affairs, Gastroenterology

• Maintain a program-level overview of clinical laboratory status and issues
• Communicate progress, risks, issues, or changes affecting quality, timelines, and budget
• Oversee clinical laboratory timelines across assigned programs
• Review plans and provide clinical laboratory operations decision making for early lab engagement, study start-up, and conduct phases
• Ensure timely delivery of operational deliverables and consistency of processes across clinical study teams
• Lead and facilitate strategic forums, planning, and operational efforts
• Set objectives and goals and support organizational planning for vendor visits, lab leadership, and cross-functional business reviews
• Support laboratory strategy and allocation, translational meetings, IVDR committee workflows, and program budget management
• Review key metrics and KPIs and drive action plans to address issues
• Build relationships with internal, cross-functional, and senior leadership partners
• Communicate program direction and provide executive summaries while maintaining operational detail
• Bridge clinical trial laboratory operations across research, translational medicine teams, and technology centers at Regeneron
• Manage laboratory delivery timelines for clinical trials and human-sample projects
• Drive decision making and lead program direction, delivery, implementation of strategic change, and continuous-improvement initiatives
• Incorporate industry best practices and innovation into operations

Clinical Laboratory Project Manager

• Build productive external partnerships across key areas
• Support identification, execution, and management of strategic relationships with organizations and institutions
• Coordinate across matrixed teams to identify opportunities and streamline external partnership initiation and maintenance
• Build an internal external-partnership capability regarded highly by partners and leaders
• Partner with internal leaders working with external partners to ensure collaboration, continuity, and alignment
• Develop and implement pharmacoepidemiology strategy in a designated therapeutic area
• Lead cross-functional project teams and epidemiology activities, including regulatory agency-required studies
• Generate epidemiology data supporting clinical development, regulatory filings, and approvals
• Serve as an in-house epidemiology subject matter expert
• Generate real-world evidence and conduct post-marketing epidemiologic studies, including PASS, PAES, PMR, DUS, and effectiveness of REMS and RMMs
• Contribute to Risk Management Plans, benefit-risk analyses, signal management, regulatory agency responses, and regulatory filings
• Provide epidemiological and risk-management strategy and support to project and product teams
• Design, implement, and analyze epidemiological studies
• Review study proposals from internal and external sources
• Explore external electronic patient-level databases, including claims, EMR, surveys, and registries
• Represent Pharmacoepidemiology on safety monitoring teams, clinical study teams, safety oversight committees, and independent data monitoring committees
• Lead non-compound-specific activities such as literature reviews and database queries
• Develop and maintain relevant SOPs and Working Instructions
• Drive process improvement activities and strategic initiatives
• Manage contractors and external vendors
• Develop and maintain professional relationships with external experts and opinion leaders

Director, Pharmacoepidemiology

Account Manager

• Identify key stakeholders within oncology accounts and tailor engagement strategies to local healthcare needs and priorities
• Establish and lead high-quality interactions with healthcare professionals
• Maintain current scientific knowledge and deliver aligned brand messaging
• Communicate the value proposition through clear and consistent key message delivery
• Develop and execute local account plans aligned to the Dutch Brand Plan
• Use market insights and relevant data sources to guide account planning
• Partner with medical colleagues to implement regional programs and activities
• Communicate account results, market developments, and business updates to the Netherlands leadership team
• Balance face-to-face and digital engagement channels to optimize customer interactions and impact
• Execute strategic and tactical plans independently

Key Account Manager – Oncology

Financial Planning and Analysis

• Oversee collaboration arrangements and work with functional finance teams and Strategic Alliances to manage deliverables and milestones
• Lead, participate in and coordinate Joint Finance Committees for multiple collaborators
• Manage meeting materials, including presentations, agendas and meeting minutes
• Proactively identify potential issues and collaborate with internal and external stakeholders to problem solve
• Prepare financial analysis for ad hoc requests and special projects for senior management
• Work with internal Finance colleagues on corporate needs and Alliance data deliverables, including Quarterly Reforecasts
• Manage milestone and royalty obligations to and from Regeneron across collaborations
• Analyze quarterly budget-to-actual variance reports
• Compile, develop and analyze commercial-related forecasts for partnered products with Commercial/Medical Affairs Finance colleagues
• Work with Accounting to reconcile quarterly actuals for settlement with collaborators

Senior Manager, Strategic Finance

Scientist

• Analyze biomarker data types across Precision Medicine and biomarker studies
• Provide computational and technical expertise in data cleaning and data visualization
• Integrate complex datasets and perform statistical analysis on exploratory biomarker data and clinical endpoints
• Use technical tools, programming languages, custom coding, and systems analysis to clean data and select or create datasets for analysis
• Identify data anomalies and collaborate with data stewards on root cause analysis of data quality issues
• Prepare scientific presentations, manuscripts, reports, quality-checked tables, and graphs
• Communicate analytical plans and timelines for multiple concurrent projects
• Develop, benchmark, and implement computational workflows
• Maintain coding and data cataloguing practices for consistency and reproducibility
• Develop tools and dashboards for processing, analyzing, querying, visualizing, and cleaning data