Regeneron

Director

• support Clinical Biostatistics with Global Development
• lead efforts of the Biostatistics department 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
• work with teams to appropriately interpret the results and make decisions
• represent statistical issues in regulatory agency meetings
• lead the development and delivery of training to non-statistical colleagues
• lead the development of new infrastructure and processes
• mentor and oversee less experienced statisticians, with the potential to manage full-time staff

Associate Director, Biostatistics – Cardiovascular/Metabolism

Manager

• Lead TMF Health initiatives to ensure accuracy and completeness.
• Collaborate with CROs and internal teams to resolve documentation issues.
• Present eTMF updates at study-related meetings.
• Develop and maintain TMF plans and inventories.
• Conduct reviews to confirm inspection readiness.
• Communicate metrics and compliance updates to stakeholders.
• Manage process improvement projects within the TMF organization.

TMF Manager

• Provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas
• Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution
• Projects, allocates and prioritizes DM resources within the assigned therapeutic projects
• Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget
• Mentors junior data managers for skills advancement
• Leads and performs clinical data management tasks for studies if required
• Ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP’s and work instructions in compliance with applicable regulations
• Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects
• Designs and modifies CRF

Manager, Clinical Data Management – Study Lead

• oversee the creation and management of the Neurology Field Medical team
• have direct line leadership including, hiring, goal setting, performance evaluation
• provide oversight of all activities in accordance with current regulatory and health care compliance guidelines.
• provide scientific exchange and collaboration with thought leaders on disease and product information as well as research initiatives.
• participate in the development and management of company and investigator sponsored clinical trials.
• establish a highly functioning, customer centric, credible and compliant field medical organization.
• ensure appropriate training and compliant execution of initiatives and other permissible field activities
• ensure team field activity level and field metrics
• collaborate with internal partners to ensure alignment and communication of Medical Affairs field medical goals and team value proposition.
• assist in the creation and implementation of field strategies for healthcare professionals
• participate in the development of educational materials/evidence communication tools and champion the regulatory/legal/health care compliance approvals.
• aid in the creation and implementation of field collaborative strategies to ensure compliant partnership with customer-facing teams
• assist with management of clinical data through support of abstracts, posters, presentations and manuscript development to ensure accurate communication of scientific and clinical results.
• appropriately engage healthcare professionals and attend conferences to collect and report relevant medical insights.
• develop strategic plans and coordinate activities for Neurology scientific meetings and congresses.
• develop strategies for maintain lists of Neurology experts/investigator targets and associated plans of action.
• ensure company policies and financial controls are maintained with integrity and professionalism.

Senior Director, Field Medical Affairs – Neurology

Software Engineer

• Provide timely support to the study team on all programming matters according to the project strategies
• Provide project leadership and programming support for processing data from clinical studies
• Assist in providing guidance in implementing and executing the programming and project standards
• Oversee projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses

Principal Statistical Programmer

• Oversee team members to ensure all activities align with Regeneron’s procedures and industry best practices.
• Collaborate closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs.
• Shape and implement the strategy for External Data Services.
• Lead and manage a team of External Data Services Managers and Specialists.
• Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards, processes, and timelines.
• Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations.
• Represent External Data Services in leadership forums and technology discussions.
• Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services.
• Identify process gaps and lead initiatives to improve processes.
• Track milestones and deliverables, escalate issues, and communicate portfolio-level updates to stakeholders.
• Lead or contribute to special projects requiring strategic input and expertise in External Data.
• Develop SOPs, Work Instructions, Guidance Manuals, and other DTS development tools.
• Provide coaching, mentoring, and performance management for direct reports.
• Manage resource allocation and planning for External Data Services.

Associate Director, External Data Management

• Provide timely support to the study team on all programming matters according to the project strategies.
• Assist in providing guidance in implementing and executing the programming and project standards.
• Oversee projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses.
• Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.

Operations

• Responsible for the execution, functional reporting, and imaging operational oversight of specific portfolios/assets
• Collaborate with clinical operations study leads and cross-functional teams to manage the start-up activities of imaging components
• Author, review, and/or manage essential study documents required for clinical trials
• Provide technical support and training to clinical site personnel

Senior Manager, Clinical Imaging Operations

Sales

• Deliver results by meeting or exceeding objectives guided by Regeneron Way values.
• Attract, retain, develop and lead a team of Immunology representatives across multiple therapeutic areas.
• Inspire and motivate through adult-learning principles and by leading by example.
• Maintain open lines of communication with the team and ensure all members work efficiently and collaboratively.
• Collaborate effectively with internal and external stakeholders across functions (e.g., PSP, Medical).
• Foster a culture of curiosity by asking questions of your team and healthcare professionals (HCPs).
• Build relationships with regional Key Opinion Leaders (KOLs) and HCPs to understand their needs.
• Monitor and share field insights and engagement activities with management.
• Ensure business and engagement plans align with brand strategies to drive success.
• Optimize team resources by managing budgets, reporting, and other management systems.

Regional Sales Manager – Otolaryngology, Gastroenterology

• Lead and oversee the end to end process of PRO support from data collection to data analysis within BDM in collaboration with HEOR team ensuring statistical rigor and appropriateness, and regulatory adherence and HTA requirement fulfillment.
• Create, develop and refine PRO statistical analysis plans (PRO SAP)
• Contribute to PRO analysis section in the protocol and clinical study SAP when applicable, authoring technical documents, including statistical analyses plans, programming specifications and TFL mock shells.
• Establish and guide modeling expertise in various PRO instruments under different trial designs.
• Conduct appropriate statistical analyses and convey findings to internal and external stakeholders.
• Apply fit for purpose statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
• Work collaboratively with statistical programming and provide detailed and timely guidance towards the planned analyses, overseeing vendor selection, contract, budget and project management.
• Manage the PRO team and mentor junior staff, promoting knowledge sharing, continuous learning, and an innovative and collaborative environment.
• Serve as the primary contact for PRO analysis for HEOR team and lead statistical efforts on PRO with BDM, managing timelines, resources, budgets, contracts, vendors, and coordination across departments and external stakeholders.

Director, Biostatistics – Patient Reported Outcomes

• Serve as the first point of contact for all safety related issues for assigned compounds
• Lead the safety strategy and ensure support from within GPS
• Represent Global Patient Safety on cross-functional teams
• Identify and develop safety strategies and planning
• Act as a resource for medical review for complex ICSRs
• Participate in the development and maintenance of relevant SOPs and working practices
• Cultivate cross functional relationships and mentor junior safety scientists

Director, Global Patient Safety Sciences – General Medicine

• Serves as the first point of contact for all safety related issues for the compound(s)
• Leads safety strategy and ensures optimal support from within GPS
• Works collaboratively with stakeholders to deliver the safety strategy
• Responsible for all aspects of Global Patient Safety activities for assigned compounds and products in support of safety surveillance, signal management
• Represents Global Patient Safety on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT)
• Proactively identifies and develops safety strategies and planning for non-compound specific Global Patient Safety activities
• Act as a resource for medical review for complex ICSRs and other data sources of assigned compounds
• Actively participate in development and maintenance of relevant SOPs, working practices and guides
• Participate in continuous improvement activities within both the TA and GPS organization

Director, Global Patient Safety Sciences – Neurology

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Senior Manager, Global Patient Safety – General Medicine

• oversee regional hiring, deployment, and leadership responsibilities for oncology focused Field Medical Associate Directors/MSLs
• collaborate in setting Oncology Field Medical team strategy and metrics
• manage partnership collaborations for field medical support of evidence communication and generation activities
• support team in external expert HCP scientific exchange and education
• direct line leadership including hiring, goal setting, performance evaluation and all aspects related to direct report supervision
• collaborate with internal team members to ensure alignment and communication of Medical Affairs field medical goals
• develop and assist with partnership strategy for shared field medical support of collaboration compounds and products
• lead all aspects of development and field execution of field strategy & territory plans
• manage company-sponsored clinical trials between AD and Clinical Development and investigator
• provide consistent leadership and oversight to excellence in AD external health care provider scientific exchange across all HCP-types
• oversee execution of strategic plans and coordination of activities for Oncology scientific meetings and congresses
• collaborate with Medical Information to develop, plan, and review materials used for response to scientific inquiries.
• ensure company policies, principles, and financial controls are maintained with integrity and professionalism.

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

• Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA).
• This position is directly responsible for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.)
• The GPS Lead is the GPS representative on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound.
• The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety profile and the safety strategy.
• Assigned compounds will include a variety obesity/metabolism products in various stages of development.
• This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management.

Associate Director, Biostatistics – Cardiovascular/Metabolism

TMF Manager

Manager, Clinical Data Management – Study Lead

Senior Director, Field Medical Affairs – Neurology

Principal Statistical Programmer

Associate Director, External Data Management

Principal Statistical Programmer

Senior Manager, Clinical Imaging Operations

Regional Sales Manager – Otolaryngology, Gastroenterology

Director, Biostatistics – Patient Reported Outcomes

Director, Global Patient Safety Sciences – General Medicine

Director, Global Patient Safety Sciences – Neurology

Senior Manager, Global Patient Safety – General Medicine

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

Senior Director, Global Patient Safety – General Medicine