Regeneron

Director

• provide leadership and strategic vision for the Portfolio Management group, supporting Clinical Development Units, cross-functional Strategic Program Teams (SPT’s) for all clinical assets
• partners with Global Program Heads (GPH’s) and key functional leaders to ensure data enabled, timely portfolio and asset level decision making with key inputs from Research, Development, Manufacturing and Commercial
• identify and champion Portfolio and Asset Development best practices, including the use of dashboards, templates, tools, systems and processes to drive efficiency, alignment, decision making, and communication
• leverage Program and organizational knowledge, leadership, and facilitation skills to enable Program and Portfolio Management Teams to drive alignment, collaboration, and accountability within the SPTs and across corporate functions resulting in achievement of company and program goals
• drive portfolio level program planning, including cross-functional resource planning, financial, and capacity assessments; contribute to long-range and budgetary planning
• ensure effective communication of Program and Portfolio Management information to the broader organization
• lead program and portfolio communication and reporting in partnership with executives and functional leaders, including developing and delivering monthly dashboards and program and portfolio reviews to the Executive Team, key business partners, and the Board of Directors
• develop strong working relationships with key stakeholders within and outside of Regeneron (functional leaders, peers, vendors, pharma industry community, and external opinion leaders)
• provide information to support portfolio decision making aligned with decisions on progression of individual assets

Executive Director – Portfolio & Resource Management

Sales

• Collaborate to build and sustain a high-performance team culture.
• Oversee and lead a team of MRs (Medical Representatives) within the assigned region.
• Conduct training for new employees in collaboration with HR and talent development programs.
• Manage the performance of MRs in the assigned region.
• Provide targeted and effective feedback, coaching, training, development plans, and talent management for direct reports.
• Identify best practices and share them across the department.
• Build effective and productive partnerships with Regeneron's alliance companies.
• Enhance Regeneron's reputation and expand relationships with key HCPs (Healthcare Professionals).
• Ensure that direct reports acquire high-level knowledge of products, competitive treatments, and market environments.
• Monitor and track key performance indicators to achieve sales and behavioral goals in the assigned region.
• Manage and allocate resources effectively to ensure sales targets and profitability are achieved.
• Manage budgets across the assigned region and demonstrate ROI for investments.

Sales Manager – Respiratory

• Lead therapeutic area training and new resource development for Immunology and Inflammation Field Medical Affairs
• Collaborate with cross-functional partners
• Develop & deliver engaging training programs (virtual and live)
• Expand medical content creation
• Engage with APP External Experts in production of content for live, virtual, and digital training platforms and customer-facing resources
• Co-lead creation & implementation of customized scientific communication materials
• Build strategic and customized curricula for medical teams needs and emerging clinical data
• Lead strategy & execution of ongoing customer facing medical scientific training
• Lead the teaching and presenting of medical and scientific concepts
• Develop ongoing training curricula reinforcing medical strategy and educational updates on emerging clinical data
• Prepare, organize, and delivers an effective and engaging onboarding training experience for field medical new hires
• Monitor Industry Medical Affairs standards and provide recommendations for process improvement

Director, Field Medical Affairs Training – Immunology, Inflammation

Communications

• Drive the development and alignment of scientific communications plans for Neurology Global Medical Affairs strategy
• Develop global scientific communications platforms
• Implement comprehensive and integrated medical communication plans
• Ensure the quality and impact of all projects and alignment with internal and external partners
• Identify and prioritize scientific educational opportunities
• Collaborate with Scientific Communications Lead
• Lead projects through medical review committees for approval

Associate Director, Scientific Communications – Neurology

• establish and lead the data stewardship function
• define the strategic vision, operating model, and foundational processes
• partner with Data Governance to implement enterprise-wide data policies, standards, and SOPs
• collaborate with system Business Process Owners
• ensure stewardship activities support enterprise analytics, data products, and AI/ML initiatives
• curate and maintain business metadata
• ensure the quality, integrity, and completeness of portfolio-level data
• design and oversee development of dashboards and reports
• champion a data-driven culture by developing training, guidance, and communication strategies

Director PPM Data Stewardship Lead

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

• 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