Regeneron

Operations

• Lead a centralized capital organization including project controls, capital project management, business analysis, and strategy
• Establish and govern enterprise-wide capital project lifecycle standards from concept through closeout
• Drive Front-End Planning (FEP) processes, ensuring robust scope definition, risk identification, and investment-grade estimates
• Support long-range capital planning through accurate project data, forecasts, and portfolio insights
• Oversee project controls, including cost, schedule, risk, and performance reporting
• Provide strategic capital insights through surveillance programs and portfolio health analytics
• Partner cross-functionally with engineering, manufacturing, quality, finance, and executive leadership to align investments with business strategy
• Champion continuous improvement across capital processes, tools, and methodologies

Associate Director – Capital Office Operations

Manager

• Supporting development of a comprehensive external communications strategy aligned to R&D and enterprise objectives.
• Collaborating with scientists, physician-scientists, medical affairs, regulatory, and operational teams to translate complex scientific topics into compelling stories.
• Identifying and securing speaking engagements, media opportunities, and events for R&D functional leaders.
• Leading project management and execution of reputation-building campaigns.
• Overseeing external PR agencies/vendors and external partners to drive quality, timelines, budgets, and integration across workstreams.
• Defining measurement plans and dashboards using data and feedback to optimize content and demonstrate impact.

Manager, R&D Thought Leadership

• Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks.
• Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.
• Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
• Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
• Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
• Partner with cross functional and CRO partners to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.
• Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
• Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.
• Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).
• Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
• Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
• Oversee CRO site start up management or in house site facing regional SSU team, where applicable
• Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
• Oversee the preparation and approval of site regulatory package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
• Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
• Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution.
• Recommends and participates in cross functional and department process improvements.

Manager, Global Site Start-Up Lead

• Support end-to-end CDx strategy and execution to enable therapeutics across indications.
• Partner with biomarker, clinical, regulatory, commercial, and IVD collaborators.
• Own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment.
• Manage IVD partners—negotiating scope, timelines, budgets, and quality.
• Embed CDx assays in trials with clinical teams for reliable execution.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation and audit readiness.

Senior Manager, Clinical Diagnostics CDx – Precision Medicine

Director

• Define the strategy to ensure standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs through development of common practices, processes, templates
• Oversee relevant training programs for GPS Safety Sciences, including a standardized training curriculum, proficiency matrix, and knowledge management repository
• Enable the Global Capability Center (GCC) to operate more efficiency and scale with the demands of the business
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI
• Ensure compliance and quality management of Safety Sciences Operations activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools
• Oversee all aspects of signal detection coordination and signal management process across all TAs, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER)
• Coordinate and support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required
• Set and oversee the framework for aggregate safety data analysis to ensure effective coordination and delivery
• Serve as strategic point of contact to enable SS operational delivery in partnership with TAHs and GPS Leads
• Partner with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management)
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
• Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

Executive Director, Global Patient Safety Sciences Delivery

Product Manager

• Lead and coach Product Leads and Product Analysts, ensuring delivery on commitments and building domain capabilities.
• Coordinate operational support across the product portfolio, managing backlog, incidents, and enhancement trends.
• Partner with Business Process Owners and Business Solution Partners to implement and enhance technology products end-to-end.
• Assess and prioritise domain requirements, aligning technology roadmaps with product priorities.
• Identify resourcing needs and coordinate internal and vendor delivery in support of product operations.
• Navigate ambiguity and competing priorities, keeping teams focused on delivering value.

Director, Product Management – Delivery & Operations

• Provide timely support to the study team on all programming matters
• Provides project leadership, resource planning/coordinating deliverables within project or across multiple projects
• Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan
• Provide programming support for all PMX deliverable in HAR request, data driven analysis, publications, conference
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports

Associate Director, Statistical Programming – Pharmacometrics

• Provide strategic and scientific expertise to the Clinical Pharmacology group
• Represent Clinical Pharmacology at relevant meetings
• Provide subject matter support to clinical programs in the Oncology area
• Proactively identify and contribute significant PMx inputs for research and development programs
• Design and conduct PMx analysis plans and apply scientific techniques for PK, PD analyses
• Prepare and deliver nonclinical or clinical study reports and regulatory submission documents

Associate Director, Clinical Pharmacology – Oncology

• Support HCP offices in acquiring appropriate access to Regeneron products for patients
• Ensure efficient access, effective pull-through, and understanding of access services
• Drive and support the company and divisional reimbursement strategy
• Work cross-functionally and collaboratively with Regeneron and Alliance sales organizations
• Build and execute a Strategic tactical plan for the execution of Alliance products access and reimbursement initiatives
• Provide appropriate process, payer and specialty pharmacy support services
• Educate physician offices regarding coverage of alliance products
• Establish and maintain knowledge on the local and national payer landscape
• Establish relationships within targeted healthcare provider offices

Field Reimbursement Manager – Dermatology

Account Executive

• Own and manage a portfolio of approximately 10 -12 AMCs and neuromuscular specialty centers within an assigned U.S. region, serving as the institutional commercial lead.
• Develop and execute comprehensive account plans for each institution, including formulary strategy, stakeholder mapping, competitive positioning, and patient access pathways.
• Navigate complex institutional buying environments including P&T committees, pharmacy contracting, hospital administration, and infusion center operations.
• Build and maintain deep, trust-based relationships with neurology department heads, treating neurologists, clinical pharmacists, infusion nurses, and medical directors.
• Lead formulary and pathway submissions and P&T committee presentations at targeted institutions, positioning the C5 inhibitor for preferred or unrestricted formulary status.
• Partner with Market Access National and Payer Account Directors to align institutional contracting with broader payer strategy and resolve prior authorization barriers.
• Coordinate with specialty pharmacy partners and Patient Services hub to ensure seamless reimbursement workflows for buy-and-bill infusion products.
• Track formulary status, pull-through metrics, and access barriers across all assigned accounts; escalate systemic issues with data-driven recommendations.
• Identify, develop, and maintain relationships with key opinion leaders (KOLs) in neuromuscular medicine within assigned territory, in coordination with Medical Affairs.
• Represent Regeneron at national and regional neurology congresses (AAN, MGFA), medical education events, and institutional grand rounds as appropriate.
• Maintain detailed CRM records and account intelligence; leverage IQVIA/Symphony Health data for prescriber-level targeting and performance measurement.
• Track and report on KPIs including accounts engaged, formulary inclusions achieved, patient switches, revenue per account, and competitive share of voice.
• Prepare and present quarterly business reviews to the Executive Director, highlighting account progress, barriers, competitive dynamics, and resource needs.
• Contribute to territory realignment recommendations and Year 2 expansion planning based on field-level market intelligence.

Neurology Account Director

Medical Director

• Serve as Medical Lead for clinical trials and responsible for design of clinical study concepts leading to clinical trial protocols.
• Oversee the medical monitoring of clinical trials to ensure patient safety and adherence to regulatory guidance.
• Lead clinical study and protocol development and present to internal and external stakeholders.
• Provide clinical and scientific leadership for data review, study reports, and publications.
• Collaborate with cross-functional partners to advance program goals and key deliverables.
• Work closely with discovery teams to help shape future targets and development opportunities.

Medical Director, Clinical Development, Endocrinology

• Serve as the primary scientific presence in your territory
• Engage in meaningful exchange of clinical data and medical information with KOLs, HCPs, clinical research investigators, pharmacists, and other decision makers
• Build investigator relationships, site infrastructure, and medical intelligence that shape our program’s clinical and medical trajectory
• Align field activities with strategic medical plans
• Gather actionable insights on the evolving treatment landscape
• Support research and development that advances both the pipeline and patient outcomes
• Collaborate with Clinical Development to identify, qualify, and establish clinical research sites in your territory
• Cultivate investigator relationships ahead of study activation to build scientific credibility and organizational trust
• Map the KOL and investigator landscape in allergy/immunology to inform clinical and medical strategy
• Gather early field insights into treatment patterns, unmet needs, and emerging science to shape the medical plan
• Support development of medical affairs infrastructure, including educational materials and scientific exchange tools, prior to launch
• Act as a primary clinical/scientific resource to HCPs for disease-state and product information
• Establish, foster, and maintain peer relationships with KOLs in allergy/immunology
• Identify and report medical insights
• Identify research gaps and educational needs to inform medical strategy
• Respond to requests for information related to study indications, disease states, and the therapeutic area

Associate Director, Field Medical Affairs – Allergy

• Serve as the primary scientific presence in your territory, engaging in meaningful exchange of clinical data and medical information with KOLs, HCPs, clinical research investigators, pharmacists, and other decision makers
• Build investigator relationships, site infrastructure, and medical intelligence that shape our program’s clinical and medical trajectory
• Align field activities with strategic medical plans, gather actionable insights on the evolving treatment landscape, and support research and development that advances both the pipeline and patient outcomes
• Collaborate with Clinical Development to identify, qualify, and establish clinical research sites in your territory
• Cultivating investigator relationships ahead of study activation to build scientific credibility and organizational trust
• Mapping the KOL and investigator landscape in allergy/immunology to inform clinical and medical strategy
• Gathering early field insights into treatment patterns, unmet needs, and emerging science to shape the medical plan
• Supporting development of medical affairs infrastructure, including educational materials and scientific exchange tools, prior to launch
• Acting as a primary clinical/scientific resource to HCPs for disease-state and product information to ensure awareness and understanding
• Establishing, fostering, and maintaining peer relationships with KOLs in allergy/immunology
• Identifying and reporting medical insights
• Identifying research gaps and educational needs to inform medical strategy
• Responding to requests for information related to study indications, disease states, and the therapeutic area, and discussing scientific and clinical data with appropriate audiences in a compliant manner.
• Ensuring company policies, procedures, principles, and financial controls are upheld with integrity and professionalism.

• Build peer relationships with key opinion leaders in haematological malignancies
• Act as a clinical and scientific resource for healthcare professionals
• Support company-sponsored clinical trials, including investigator selection and enrolment activities
• Collaborate with Clinical Development and trial teams to execute medical plans
• Identify medical insights, research gaps and opportunities with investigators
• Present scientific and clinical data in response to appropriate information requests
• Communicate complex data clearly to varied scientific and clinical audiences
• Balance field work, projects and changing priorities with sound judgement

Senior Manager, Field Medical Affairs – Haemato-Oncology

Sales

• responsible for a variety of customer engagement activities (meeting with Healthcare Professionals (HCPs)
• representing Immunology division at key meetings
• identify key people in Immunology
• tailor calls based on individual and account requirements
• build KOL support for Immunology portfolio
• establish and lead HCP interactions by keeping scientific knowledge up to date
• implementing sales & marketing plans
• delivering on brand value proposition
• act as manager in territory
• collaborate with medical colleagues to implement regional programs
• leverage communication channels to achieve the best share of voice
• report results to leadership team

Associate Director – Capital Office Operations

Manager, R&D Thought Leadership

Manager, Global Site Start-Up Lead

Senior Manager, Clinical Diagnostics CDx – Precision Medicine

Executive Director, Global Patient Safety Sciences Delivery

Director, Product Management – Delivery & Operations

Associate Director, Statistical Programming – Pharmacometrics

Associate Director, Clinical Pharmacology – Oncology

Field Reimbursement Manager – Dermatology

Neurology Account Director

Medical Director, Clinical Development, Endocrinology

Associate Director, Field Medical Affairs – Allergy

Associate Director, Field Medical Affairs – Allergy

Senior Manager, Field Medical Affairs – Haemato-Oncology

Sales Specialist, Immunology