Regeneron

Manager

• Lead and manage the reimbursement field team in the Northeast for Regeneron.
• Work with the Sales and Access leadership teams within REGN and Sanofi counterparts to lead Regional and local strategy for payer and provider access.
• Develop and implement local tactical plans for execution of all access initiatives and relevant to defined needs in each respective customer market.
• Lead and coach to identified measurable performance parameters and monitor performance against these agreed parameters.
• Proactively collaborate and communicate with Sanofi partners to achieve brand goals and performance metrics.

District Manager – Field Access

• responsible for providing oversight of individual or multiple clinical programs
• forecasting Investigational Product (IP) supply requirements for multiple clinical trials
• managing the IP distribution process to one or more clinical trials
• contributing to ongoing process improvement initiatives
• collaborating and interacting with clinical trial managers, development program managers, medical monitors, and staff from quality, clinical compliance, regulatory, formulations, and IOPS

Senior Manager, Clinical Drug Supply & Logistics

• accountable for centralized monitoring activities for global and/or complex trials
• analytical data review of key risk and/or operational performance data
• present as an integral member of the Clinical Study team for clinical development studies
• responsible for development and authoring activities of the Central Monitoring Plan
• participate in the Quality Risk and Control Tracker (QRACT) development
• work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies
• document the output from Central Monitoring Review meetings and track decisions/actions

Senior Manager, Central Monitoring

Director

• Lead market research activities and analyze data to deliver clear, actionable insights.
• Build patient flow models and demand forecasts to support business strategies.
• Collaborate with internal teams and external partners to centralize data management and reporting.
• Partner with local teams to support field alignment, segmentation, and incentive compensation.
• Work with marketing and IT teams to implement omnichannel analytics and reporting.

Associate Director, Customer Insights – Rare Disease

• Serve as a high-impact subject matter expert in investigational product management and pharmacy operations across clinical portfolio
• Guide best practices for investigational product handling, preparation, and administration
• Develop high-quality pharmacy documentation and training
• Support global clinical sites to ensure safe, compliant, and streamlined trial execution
• Partner closely with Formulation Development Group, Clinical Operations, and CDSL leadership
• Lead or contribute to Kick-Off Meetings, Site Initiation Visits, Investigator Meetings, and IP-focused training
• Support the review and resolution of IP-related deviations and practice-based issues
• Manage ancillary supply compatibility assessments in collaboration with FDG
• Provide guidance on IP-related quality assurance issues and support risk mitigation strategies
• Develop engaging training modules for internal teams and research sites

Senior Manager, Pharmacy Support Services

• responsible for translating clinical study designs and key planning parameters into robust demand forecasts
• collaborates with Clinical Drug Supply Managers to prepare and present study-level forecasts and demand plans
• advises Clinical Drug Supply & Logistics (CLO), IOPS and Clinical management of resource constraints
• manages Drug Projection Review Committees in partnership with Clinical Drug Supply & Logistics (CLO)
• defines and tracks KPIs to measure forecast accuracy
• participates in the management of advanced forecasting and simulation software
• optimizes demand through the analysis of multiple scenarios and comparing associated cost and risk

Senior Manager, Clinical Drug Supply Planning, Forecasting

• Establishes and maintains oversight of 3rd party IRT vendor
• Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol
• Develops and manages system deployment timelines for IRT
• Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans
• Coordinates user acceptance testing
• Manages the deployment of IRT applications with internal teams and contract vendor
• Provides guidance related to contracted vendors’ functionality, performance, and processes
• Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
• Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management
• Ensure effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor
• If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements
• May require up to 25% travel

IRT Manager, Clinical Supply Systems

Sales

• Strengthen engagement with Healthcare Professionals
• Shape account plans and build support with key people in Oncology
• Combine scientific confidence with compliant selling to optimise clinical practice
• Own territory with support from medical and commercial partnerships
• Use various channels to engage customers
• Report performance, trends, opportunities, and risks to UK leadership
• Represent Regeneron Oncology at meetings and congresses as required

Sales Specialist, Oncology

• Provide guidance and leadership for the CSV Auditing group
• Build strategic partnerships and implement risk-based quality auditing activities across GDQA
• Lead audits of higher complexity (e.g., directed audits)
• Schedule, prepare, conduct, report and follow-up on routine and directed CSV audits
• Support other GxP (GCP, GLP, GVP) audits as a CSV SME
• Guide and train team members

Manager, Computer System Validation – Auditing

Compliance

• provide leadership on global regulatory activities for assigned products
• focus on clinical regulatory filings
• provide regulatory leadership on project teams
• supply, lead and/or supervise IND/CTA and BLA submissions
• interpret regulatory authorities’ feedback, policies, and guidelines
• develop regulatory strategic plans with project teams
• own preparation of major clinical submissions for regulatory approval
• resolve complex project issues
• ensure quality and timeliness of IND/CTA and BLA submissions
• interact with functions and partners in preparation, review, and completion of documents
• assure compliance with regulations and project team timelines
• provide interpersonal support and lead personnel
• critical thinking, strong negotiation and project management skills

Director, Regulatory Affairs Strategy – Oncology

• Lead Precision Medicine (clinical biomarker) strategy development and execution to support the clinical development portfolio
• Lead biomarker development and implementation through the application of genomic (RNA and DNA sequencing), protein and cell/tissue analysis
• Champion early-adoption of biomarker strategy for pipeline pre-clinical programs
• Represent Precision Medicine on cross-functional strategic project teams and global clinical sub-teams
• Provide cross-functional team leadership of internal clinical biomarker discovery platform development
• Present clinical translational project plans, clinical trial protocols, biomarkers data and interpretation of results to internal stakeholders
• Evaluate emerging technologies and vendors to consider for future programs
• Willingness to work across multiple therapeutic areas

Associate Director, Precision Medicine

IT Support

• Create Solution Architecture and Design to implement scalable, robust, and secure solution for applications using BPM technologies and Automation tools.
• Work with Automation Architects, Application Architects, Integration Architects, Security Architects, Infrastructure, Platform and Enterprise Architects and lead the development of Solutions for Process and task automation solutions leveraging tools such as UiPath, Power Automate, Agentic AI platforms.
• Build AI-driven solutions using Agentic AI for intelligent automation and decision-making processes.
• Develop and implement digital automation strategies tailored to the unique needs of the Life Sciences Industry, ensuring compliance with industry standards and regulations.
• Identify opportunities for process improvement and task automation, delivering measurable efficiency gains.
• Stay updated on emerging trends in automation and AI technologies to drive innovation within the organization.
• Work closely with Infrastructure Architects, Platform Architects, and Security Architects to ensure solution designs align with infrastructure, security, and compliance requirements.
• Collaborate with Application Architects and Development Teams to implement end-to-end solutions that meet business and technical goals.
• Communicate technical concepts effectively to both technical and non-technical stakeholders.
• Create comprehensive technical documentation, including architecture diagrams, design specifications, and operational guidelines.
• Prepare and deliver presentations to stakeholders, articulating automation challenges, capabilities, and proposed solutions.
• Ensure solutions are optimized for AWS Cloud and other infrastructure platforms, considering factors such as scalability, performance, and cost efficiency.
• Address security and compliance requirements in collaboration with Information Security teams.
• Track and analyze key performance indicators (KPIs) to measure the success and effectiveness of the Solutions built.
• Participate in leadership meetings to provide updates on the progress, challenges, and outcomes of various initiatives.
• Working with Quality to respond to any regulatory non-compliance and related CAPA.

Director, IT Engineering

• deliver on strategies and plans of action related to Medical Affairs oncology disease states and treatments
• develop and maintain a list of therapeutic area experts highly relevant to oncology
• collaborate with Clinical Development supporting the development of oncology pipeline and marketed products
• communicate relevant scientific data to oncology experts/healthcare providers and internal team members
• participate in the development and management of company sponsored clinical trials
• review concept proposals and develop protocols
• support site initiation and enrollment activities
• act as a scientific resource for area healthcare professionals
• establish scientific relationships with investigators

Associate Director, Field Medical Affairs – Thoracic Oncology/Pan Tumor

• Provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) programs.
• Focus on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across portfolio.
• Accountable for the oversight and execution of all data management programming deliverables at the portfolio level.
• Ensure alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements.
• Manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards.
• Emphasize cross-functional collaboration, deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.
• Drive strategic leadership with full accountability for the planning, execution, and delivery of high-quality clinical data management programming deliverables across the portfolio of clinical development units.
• Provide comprehensive oversight of clinical programming and visualization outputs that reveal key insights to support clinical data review.
• Establish robust data reporting standards, implement scalable programming strategies, and optimize workflows incorporating automation.
• Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation.
• Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries.
• Establish and monitor KPIs to track performance and conformance with programming standards.

Director, Clinical Data Management – Reporting

• Support Clinical Biostatistics within Global Development
• Work with cross-functional teams to articulate drug development questions
• Assess the feasibility of endpoints and frame statistical approaches to address those questions
• Design clinical experiments and interventional studies to generate and analyze the resulting data
• Interpret the results and make decisions with teams
• Participate in regulatory agency meetings
• Co-author clinical study protocols, statistical analysis plans
• Perform statistical analyses for interim and final reports
• Develop and deliver training to non-statistical colleagues
• Mentor and oversee less experienced statisticians, with potential to manage contract staff