Regeneron

Manager

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads the feasibility assessment to select relevant regions and countries for the study
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
• Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• May be assigned unmasked tasks for studies
• Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

Senior Manager, Clinical Study Lead

Product Manager

• Lead detailed business and technical requirements' analysis for Veeva Medical CRM, Veeva Medical Vault and Medical Affairs systems, translating Medical processes into scalable, complaint system designs.
• Configure and optimize Veeva CRM components, including but not limited to: Medical Inquiry, Call Reporting, Key Medical Insights, Events, Approved email, Consent Management, Page layout, Profiles, Permission sets and Sharing Rule.
• Design and configure Veeva Vault Medical Vault objects, relationships, lifecycles, workflows, user roles, document types, and metadata to support scientific content management and medical review processes.
• Define and support AI-driven Medical Affairs workflows including automated medical inquiry categorization, sentiment and topic analysis of MSL interactions, and proactive identification of emerging medical insights.
• Collaborate with Global Development and IT team members to extract insights from CRM and other data sources using AI and digital tools.
• Define and maintain Veeva data models and data quality standards to enable AI/ML readiness, ensuring alignment across CRM and Vault platforms, including reference data, picklists, field dependencies, and master data governance.
• Partner with integration teams to design and validate integrations using Veeva APIs, Vault APIs, middleware platforms, and standard connectors with systems such as MDM, ERP, data lakes, and analytics tools.
• Collaborate with global stakeholders in Medical Affairs, GDIT functions, Corporate IT and other relevant functions to support multi-country deployments, localization, and regulatory requirements across FDA, EMA, and other regional compliance frameworks.

Senior Manager, Product Management – Delivery & Operations, Medical Affairs

Director

• Engage in scientific discussions with medical and scientific specialists
• Demonstrate deep scientific expertise about assigned molecules/products
• Build and develop relationships with key external scientific and medical specialists
• Shape and execute local medical strategy based on Global Medical Affairs strategy

Associate Director, Field Medical Affairs – Dermatology

• leads all Good Clinical Practice (GCP) inspection readiness activities
• owns the preparation, organization, and execution of inspection readiness strategy
• provides inspection readiness leadership across internally sourced studies and those outsourced to CROs
• serve as the primary CTM point of contact for all inspection-related activities
• project manager during the inspection process and assist or lead the CTM team with follow up requests
• provide guidance and support to Clinical Trial Management
• track inspection readiness meetings and action items with key stakeholders

Senior Manager, Clinical Study Inspection Readiness

Operations

• Lead Training Business Partners and designers to develop and maintain project scope, timelines & deliverables on moderately complex projects
• Partner and advise on the requirements and specifications of a project using knowledge of learning techniques and learning technologies
• Responsible to track, analyze and optimize project timeline and status from kickoff to completion
• Lead Project meetings to call out risks to timelines and delivery dates and to drive decision making for resource needs
• Use strong stakeholder and relationship skills to resolve issues as they arise
• Design and implement a robust content maintenance plan for LCoE assets
• Partner with C3 team to refine collaboration with Ops team
• Drive process improvements for the Operations team
• Identify opportunities for automation of routine tasks and AI in Learning Operations

Manager, LCoE Training Operations

• Provide timely support to the study team on all programming matters according to the project strategies
• Develop an expertise within a therapeutic area or standard tool
• Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project
• Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements utilizing Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
• Manage the effort, including esubmission deliverables
• Provide programming support for complex presentations and more complex statistical ad-hoc requests
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports
• Review and select resumes, screen and interview candidates for contractor and permanent positions
• Provide feedback to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals

Manager, Statistical Programming

• Provide timely support to the project team on all programming matters
• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming
• Manage and coordinate programming and QC of analysis datasets and TFLs
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis
• Develop data models, programming standards and code, and train end users

Senior Manager, Statistical Programming

• Leading daily stand-ups, grooming backlogs, and approving Appian user stories for study-design workflows
• Facilitating workshops with clinical stakeholders to map current vs. future processes and prioritize AI-enabled improvements
• Reviewing solution architecture to ensure secure, scalable integrations with data, analytics, and LLM-based services
• Supervise sprint progress, mitigating risks, and updating program leadership on timelines, budget, and return of investment (ROI)
• Monitoring platform performance and adoption, then identifying automation or reporting improvements
• Preparing and presenting demos or governance materials for steering committees and change-control boards

Senior Manager, Product Management – Delivery & Operations, Enabling Technologies

• Leading stand-ups, refining backlogs, and approving user stories for AI-powered authoring features
• Facilitating workshops with Clinical, Regulatory, and Medical Affairs teams to gather requirements and prioritize enhancements
• Reviewing solution architecture to enforce security, privacy, and GxP compliance across RAG, MCP, LLM, Copilot, and Claude integrations
• Tracking sprint progress, surfacing risks, and updating program leadership on scope, budget, and ROI
• Defining guardrails for citizen development and coordinating change-control / governance forums
• Monitoring platform adoption and performance to identify automation and continuous-improvement opportunities

Account Executive

• Represent the entire Regeneron ophthalmology product portfolio
• Connect to key business decision-makers and relevant Key Opinion Leaders (KOLs)
• Lead and educate customers including large provider practices and private equity groups
• Work closely with the ED Ophthalmology Accounts to educate on provider contracts
• Maximize customer executive engagement, reach, and contract education within assigned customers
• Deliver regular contract performance updates to customers
• Perform quarterly business reviews with customers
• Seek customer feedback on the Regeneron GPO program and share with Market Access and Brand leadership
• Conduct in-person meetings prioritizing customer engagement
• Spend 75% of time in customer facing activities

Ophthalmology Account Director – Southeast

• Develop Design and development of product training for pre-launch, post launch, POA and advanced training
• Creates and facilitates workshops for POA and other training meetings
• Conducting needs assessment with relevant stakeholders
• Develops content for and facilitates new hire, Phase II, and advanced training
• Responsible for developing training activities, including backgrounders and FAQs on payer landscape
• Collaborates with field force effectiveness, medical, commercial operations, market access, and brand marketing to develop high-impact training
• Monitors the effectiveness of training programs through testing and metrics platforms

Senior Manager – Commercial Training, Ophthalmology Market Access

Risk

• Representing DR during Solution Design Engineering Reviews to align new systems with recovery objectives
• Governing CMDB/DR metadata, application mapping, and interdependency documentation in ServiceNow
• Developing and enforcing DR policies, standards, and SOPs, while supervising compliance metrics and key performance indicators
• Coordinating quarterly and annual recovery tests, analyzing results, and driving corrective actions
• Partnering with engineering teams and SaaS vendors to close capability gaps, negotiate SLAs, and automate DR processes
• Acting as command-and-control lead during planned and unplanned recovery events

Associate Director – Disaster Recovery Governance

• proactively identify and provide significant Pharmacometrics (PMx) contributions
• address strategically important program needs for research and development programs
• communicate complex PMx strategies and results to the development team
• independently design, conduct and oversee PMx analysis plans
• author PMx contributions to regulatory documentation
• perform additional analyses to support regulatory interactions
• draft and review documentation for accuracy, clarity and messaging
• work directly with development or Research teams on PMx elements of program strategy
• contribute to the drafting of PMx program strategies to support standard programs
• support a study team on PMx deliverables and objectives

Associate Director, Clinical Pharmacology

• partner with sales leadership and brand team to set operational strategy in alignment with brand strategy
• coordinate and execute tactical plans to drive the commercial success of the Neurology brand
• ensure cross-functional and cross-collaboration communication
• collaborate with Analytics and Regional Directors to develop and monitor agreed metrics
• partner with Commercial Training to develop and drive Plan of Action Meetings
• manage the overall strategic and operations calendar

Associate Director, Field Force Effectiveness – Neurology

• Develop and execute a comprehensive state government affairs strategy aligned with Regeneron’s policy and business priorities, with a focus on patient access, affordability, and innovation.
• Monitor, analyze, and influence state legislation, regulation, and policy trends impacting biopharmaceutical development, reimbursement, and access (e.g., drug pricing reforms, PBM regulation, prior authorization, step therapy, and Medicaid policies).
• Lead engagement with state policymakers, including legislators, governors’ offices, Medicaid agencies, and regulatory bodies, to proactively shape policy outcomes.
• Build and maintain strong relationships with key external stakeholders, including state trade associations, patient advocacy organizations, provider groups, and industry coalitions.
• Represent Regeneron in state-based coalitions and industry associations, helping to shape collective advocacy strategies and advance shared policy priorities.

Senior Manager, Clinical Study Lead

Senior Manager, Product Management – Delivery & Operations, Medical Affairs

Associate Director, Field Medical Affairs – Dermatology

Senior Manager, Clinical Study Inspection Readiness

Manager, LCoE Training Operations

Manager, Statistical Programming

Senior Manager, Statistical Programming

Senior Manager, Product Management – Delivery & Operations, Enabling Technologies

Senior Manager, Product Management – Delivery & Operations, Enabling Technologies

Ophthalmology Account Director – Southeast

Senior Manager – Commercial Training, Ophthalmology Market Access

Associate Director – Disaster Recovery Governance

Associate Director, Clinical Pharmacology

Associate Director, Field Force Effectiveness – Neurology

Director, State Policy and Government Affairs