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
• Provides operational input into protocol development
• 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.
• Ensures compliance with the clinical trial registry requirements
• 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
• Oversees/conducts site evaluation and selection
• Leads investigator meeting preparation and execution
• 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
• Ensures accurate budget management and scope changes for internal and external studies
• 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
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• Ensure clinical project audit and inspection readiness through the study lifecycle
• Supports internal audit and external inspection activities and contributes to CAPAs as required
• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• Contributes to clinical study report writing and review
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
• May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
• 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
• May require 25% travel

Senior Manager, Clinical Study Lead – Genetics Medicine, Hepatology

Director

• Develop and evolve the global life cycle management strategy for all in-line oncology assets with Lung Cancer indications
• Shape asset plans within Lung Cancer indications in coordination with the Executive Director of Global Lung Cancer Marketing, Regulatory, Clinical, Competitive Intelligence (CI), and other cross-functional partners
• Maintain up-to-date tumor landscape outlooks for our portfolio and potential competitors
• Share current CI with Global, US, and international marketers
• Support the Executive Director of Global Lung Cancer Marketing in developing the commercial perspective for Lung Cancer assets
• Lead the Marketing team’s efforts to plan cross-functionally for new indication launches
• Analyze customer insights, monitor brand performance and competitive dynamics
• Collaborate with Global Oncology Marketing Leadership, International teams, Clinical Development, Regulatory, Medical Affairs, Market Access, and Sales

Senior Director, Global Lung Cancer Life Cycle Management Lead

Content Writer

• represent Medical Writing and provide leadership in one or more compound areas
• oversee junior writers and assist in leading regulatory submissions
• manage and develop staff, including performance management and training
• write all in-scope clinical documentation in their compound areas
• lead all MW deliverable work for assigned compounds/indications
• manage work of both internal and outsourced Medical Writers
• work with clinical team to develop document strategy and write in-scope deliverables as needed
• develop and articulate document strategy and timelines
• identify appropriate decision makers, focus on results/actions
• lead regulatory submissions/submission document writing
• participate in process improvement initiatives and new initiatives within MW and throughout Global Development
• manage processes and organize priorities; solve problems; foster collaboration to resolve conflict
• challenge and develop MW team
• ensure adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area

Associate Director, Regulatory Medical Writing

• Drive detailed delivery of commercial meetings, congresses, and training programs for International Commercial Immunology
• Partner with internal teams, vendors, and alliance collaborators across Europe, Canada, and Japan to plan, coordinate, and implement scalable events and trainings
• Handle vendor and venue selection, negotiation, and performance; coordinate contracts, SOWs, and day‑of delivery across AV, catering, exhibits, and attendee services
• Own event budgets: build forecasts, track commitments, handle POs and invoices, and reconcile actuals with post‑event reporting
• Ensure compliance with company policies and industry codes related to promotional events and HCP interactions; maintain documentation for audit readiness
• Lead all aspects of attendee communications, registration, travel, and onsite operations; troubleshoot issues to protect experience, safety, and brand standards
• Track and report KPIs and leading indicators for meetings and trainings; synthesize feedback and insights to plan for future planning and budget allocation
• Collaborate with IT and enablement teams to use event platforms and data tools; ensure data privacy, consent, and secure handling of attendee data

Manager, Meetings and Conventions

• operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out
• accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP
• lead 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
• provide operational input into protocol development
• oversee and provide 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.
• oversee set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• ensure compliance with the clinical trial registry requirements
• identify outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• provide input into baseline budget development and management
• provide input into baseline timeline development and management
• lead risk assessment and identifies risk mitigation strategies at the study level
• lead the feasibility assessment to select relevant regions and countries for the study
• oversee/conduct site evaluation and selection
• lead investigator meeting preparation and execution
• monitor progress for site activation and monitoring visits and acts on any deviations from plan
• lead the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
• monitor data entry and query resolution and acts on any deviations from agreed metrics
• ensure accurate budget management and scope changes for internal and external studies
• oversee and provide input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• escalate 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
• oversee the execution of the clinical study against planned timelines, deliverables and budget
• oversee data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• oversee and ensure the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• ensure clinical project audit and inspection readiness through the study lifecycle
• support internal audit and external inspection activities and contributes to CAPAs as required
• manage and oversee study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• contribute to clinical study report writing and review
• facilitate and contribute to study level lessons learned
• assign tasks to Clinical Study Management staff and supports their deliverables
• recommend and participate in cross-functional and departmental process improvement initiatives
• responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
• may be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
• 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
• may require 25% travel

Senior Manager, Clinical Study Lead – Hematology

• 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.
• Ensure alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements.
• Accountable for the oversight and execution of all data management programming deliverables at the portfolio level.
• Responsibilities include quality and timely delivery of programming outputs such as data review plan listings, exception listings, external data reconciliation reports, operational metrics, and other reports supporting clinical trial quality and risk management.
• 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 and deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.

Associate Director, Clinical Data Reporting

• accountable for execution of assigned clinical studies/research collaborations from study design to close out
• oversight of contract and budget execution
• study timelines and budget management
• ensures study conduct is in accordance with applicable regulations

Senior Manager, Clinical Study Lead – Clinical Experimental Sciences

• establish Regeneron as a leader in Respiratory & Immunology spaces by serving as a strategic partner and trusted advisor to high-value Integrated Delivery Network (IDN’s) healthcare accounts
• drive long-term engagement, operational excellence, and business growth
• build strong relationships across account customers including Pharmacy, P&T committee, multiple specialties, as well as operational and executive levels within the Account
• translate customer insights into actionable feedback
• support patient pull through, resolving issues, and ensure satisfaction throughout engagement lifecycle
• contribute to commercial strategy, product innovation, and market positioning
• develop, establish, and actively lead the IDN / Healthcare account strategic Account Plan
• participate in the development of new strategic marketing resources
• engage and coordinate with patient support services for proper support pull-through
• identify and remove barriers to collaboration to drive efficiency and accountability across teams
• own the development of comprehensive account profiles capturing strategic priorities, customer mapping, and growth opportunities
• analyze performance metrics, utilization trends, and customer feedback to generate insight
• maintain a dynamic view of account engagements using CRM tools and dashboards to monitor progress and inform future initiatives

Director, Immunology Key Accounts Lead

Compliance

• lead the development and execution of global CMC regulatory strategies for the Obesity portfolio
• guide regulatory activities across development stages
• mentor CMC Regulatory Affairs staff
• support cross-functional and external partners
• serve as a key liaison in regulatory authority interactions
• lead product development activities from a CMC regulatory standpoint
• represent CMC RA at program meetings
• identify program issues and develop regulatory strategies to mitigate risks
• critically review and provide input on regulatory filing documents
• facilitate interactions with global regulatory authorities
• perform final review and approval of compliance activities
• develop working instructions, SOPs, and/or templates
• identify gaps in IOPS and global RA processes

Associate Director, CMC Regulatory Affairs – Obesity

Clinical Research

• Leads the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data
• May function as lead Clinical Scientist for program
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Applies advanced scientific expertise to propose, design, and execute clinical research
• Develops the Expanded Synopsis and authors clinically relevant sections
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
• Independently leads planning and prepares information for external/stakeholder meetings
• Ensures consistent first line medical/clinical data review techniques and conventions
• Identifies areas of potential inconsistent data review and implements solutions

Director, Clinical Scientist – Immune/Inflammatory

Program Manager

• Responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM)
• Maintain overview of clinical program(s) status and issues and proactively communicate progress, risks, issues or changes
• Oversee clinical study budgets within a program
• Ensure timely delivery of quality operational deliverables and ensure consistency of process across clinical study teams

Director, Program Operations Leader – Ophthalmology/Renal

• responsible for leadership of and setting and implementation of the operational strategy for delivery of complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines, and budgets related to the conduct of clinical research studies
• interact with senior-level management, external vendors, collaboration partners, and clinical study personnel
• responsible for line management of clinical trial management staff
• develop and implement operational strategy, driving early study planning budget and timelines

Director, Program Operations – Specialty Medicine, Rare Disease

• responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s)
• maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
• provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
• oversee clinical study timelines within a clinical program(s)

Director, Program Operations Leader – Internal Medicines

• responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM)
• responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies
• operates with autonomy and high-degree of independence
• responsible for line management of clinical trial management staff
• key role in driving the functional strategy of Clinical Trial Management

Director, Program Operations – Oncology-Hematology

• Address global regulatory information requests from stakeholders
• Develop tailored reports to support compliance and strategy
• Monitor regulatory policies and assess their impact on drug development
• Draft policy recommendations for submission to Health Authorities
• Evaluate and optimize regulatory intelligence data sources
• Share updates to improve organizational awareness of changes
• Coordinate with Legal and Public Policy teams for consistent communication
• Identify trends and improve regulatory processes