Regeneron

Director

• Lead and/or oversee the 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, and work with teams to interpret the results and make decisions appropriately
• Work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy
• Represent statistical issues in regulatory agency meetings
• Lead the development and delivery of training to non-statistical colleagues
• Develop new infrastructure and processes
• Actively represent the company in professional associations, conferences, and publications
• Mentor and oversee less experienced statisticians and work with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff

Director, Biostatistics – Genetic Medicine

Medical Director

• Provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program
• Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates
• Ensures timely execution of assigned clinical deliverables within approved budget
• Supports Program Lead MD and frequently lead interactions with external stakeholders
• Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program
• Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes

Medical Director – Clinical Development, Hematology

Program Manager

• 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
• interacts with senior level management, external vendors, collaboration partners and clinical study personnel
• 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 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

Risk

• responsible for assisting in the operations, execution and oversight of global and local drug safety risk management activities as part of Regeneron’s pharmacovigilance (PV) requirements for the worldwide portfolio.
• account for assisting in all elements of planning, overseeing status reporting, managing risks and issues, collaborating with stakeholders, developing risk management tools, and proactively communicating with stakeholders on the delivery of Risk Management in support of the portfolio and RMCoE vendors.
• responsible for providing operations and oversight of the execution and tracking of Global and Local Risk Management Plans that require addition risk minimization measures (aRMMs).
• support the development, execution, and maintenance of Core Implementation Plans (CIPs) and associated materials and the Local Implementation Plans (LIPS) and associated materials.
• responsible for creating and obtaining internal approval of Global and Local aRMMs materials, and Local Implementations Plans (LIPS).
• provide and/or follow-up on aRMMs and LIP tracking and key performance metrics for RMCoE.
• follow Risk Management planning and processes to ensure compliance with global regulations as well as Regeneron Standard Operating Procedures (SOPS) and Work Instructions (WI).
• ensure risk management activities allow for effective preparation for inspections/audits.
• ensure communication of Risk Management activities and deliverables are clearly and accurately communicated between GPS/Regulatory/Qualified Person for PV Office (QPPVO/LCPPV)/External vendors and cross functional partners.
• ensure the risk assessment processes are continuously improved to reflect best practices, regulatory trends, and guidelines working across with GPS, and Regeneron stakeholders.
• support and/or participate in Regulatory Agency approvals and/or interactions including audits/inspections, PSUR,PBRERS.

Associate Director – Risk Management

Customer Success Manager

• Provide strategic oversight and enhance launch and execution excellence for our newly launching brand for Myasthenia Gravis in the US
• Create a strategic coordinated approach for our field teams calling on customers
• Lead the Field teams, motivating and developing the team to deliver upon CBU operational and financial goals and customer expectations
• Establish credible and trusted relationships with key organizational and business collaborators inside and outside of Regeneron
• Ensure Regeneron Executive Leadership is kept aware of significant external events and threats that may affect our business and proactively make recommendations to address them in a timely manner

Executive Director, Strategic Customer Engagement – Neurology CBU

Clinical Research

• lead development, evaluation, planning, and execution of clinical studies
• ensure integrity and interpretation of study data
• collaborate closely with Medical Director(s) (MDs) to provide scientific expertise
• participate in program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings
• maintain understanding of therapeutic disease area(s) and drug candidates

Senior Manager, Internal Medicine, Clinical Scientist – Cardio, Metabolic, Renal

Manager

• support Clinical Biostatistics within Global Development
• work 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
• analyze the resulting data
• work with teams to appropriately interpret the results and make decisions
• participate in regulatory agency meetings
• co-author clinical study protocols and statistical analysis plans
• perform statistical analyses for interim and final reports
• develop and deliver training to non-statistical colleagues
• lead the development of new infrastructure and processes
• influence the external pharmaceutical industry and regulatory environment

Senior Manager, Biostatistics – Thrombosis

• Assists in the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data of a clinical development program
• Contributes to candidate development projects through early and/or late phase development
• Collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
• Supports clinical/medical data review, including safety monitoring and activities that ensure patient safety

Manager, Clinical Scientist – Internal Medicine, Cardio, Metabolic, Renal

• work 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
• co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports
• develop and deliver training to non-statistical colleagues
• collaborate on development of new infrastructure and processes
• influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications

Manager, Biostatistics – Oncology

• Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables
• Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions
• Provides expertise and guidance to authors and contributors of aggregate reports
• Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance
• Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
• Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
• Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
• Acts as subject matter expert during audits and inspection.
• Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports
• Acts as a functional vendor management overseeing and driving high quality outputs from our vendors
• Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs
• Drives process improvement through automation and other tech initiatives.

Senior Manager, Aggregate Reporting Management

Sales

• Developing, implementing and supervising territory account plans based on market insights
• Ensure continuous and timely updates to the plan in response to changing market dynamics
• Outstanding account management and operational excellence applying key data sources to strategically develop a territory account plan
• Collaborating with regional colleagues and other teams to address customer needs
• Ensure patient access through partnering with key customer stakeholders

Sales Specialist

Product Specialist

• lead customer engagement across your territory, meeting Healthcare Professionals and representing Regeneron Oncology at key meetings
• bring a strong understanding of the local healthcare economy, tailoring each conversation to the account and stakeholder
• own account planning end-to-end, partnering closely with the Cross-Functional Team, with clear scope to grow your territory
• meet HCPs to discuss product science and brand messaging
• keep indication knowledge current and apply agreed sales plans consistently
• communicate brand value proposition through clear, compliant key messages
• build and manage account plans using insights and key data sources
• target and segment accounts in line with regional and country guidance
• partner with the Cross-Functional Team (Medical, Marketing, Access) to respond to HCP needs
• use face-to-face, remote, and digital channels to increase share of voice
• share progress against tactical plans with your manager and the cross-functional team

Product Specialist, Oncology

• 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 resulting data
• Represent statistical issues in regulatory agency meetings
• Mentor and oversee less experienced statisticians
• Manage full-time staff

Associate Director, Biostatistics – Immunology

Translator

• Manage the workflow of various documents needing processing, including those requiring translations
• Lead and optimize end‑to‑end translation workflows, ensuring timely and compliant processing
• Serve as the primary liaison between central functions and external translation partners
• Submit documents for translations with the translation vendor
• Develop and implement translation strategies during Mergers or Acquisitions
• Act as subject matter expert for translation needs during audits and inspections
• Oversee vendor, track progress and report out status for document requests
• Support strategic and operational special projects
• Co-chair Translations Alliance

Manager, Translation Services

• Partner with Training Business Partners and Learning Designers to adapt global learning materials to local and regional needs
• Collaborate with subject-matter experts to facilitate live training sessions
• Support consistent delivery of high-quality learning experiences across the assigned region
• Serve as a visible learning partner at regional events
• Build and maintain a network of regional subject-matter experts
• Promote learning initiatives to drive engagement and participation
• Act as a point of contact for learning-related questions
• Provide language support or translation coordination
• Act as the primary onboarding contact for the assigned region
• Develop and adapt training communications