Adaptimmune jobs in Cambridge, MA - 21 jobs

The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of complex early through late-phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects as well as tumor response assessment of oncology clinical studies in partnership with clinical sciences and preclinical research teams. In this role, a typical day might include the following: * Create fit-for-purpose imaging biomarker strategies and work closely with research, clinical imaging and the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline. * Prepare and present clinical imaging strategies to senior management. * Manage a complex network of stakeholders across Regeneron. * Lead, design and implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies. * Collaborate closely with Regeneron clinical teams as imaging subject matter expert to ensure optimal design and execution of imaging strategy including development of protocols, imaging endpoints, imaging manuals, imaging charters, statistical analysis plans and clinical study reports. * Work closely with Clinical Imaging Operations and imaging contract research organizations to ensure the flawless conduct and data integrity of studies' imaging components and endpoints. * Serve as Study Scientific Director for clinical trials focused on qualification and utilization of novel imaging biomarkers. * Lead the interaction with regulatory agencies for communications regarding imaging endpoints and procedures. * Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging biomarker development studies This Job Might Be For You If You Have: * Experience as study scientific director of PET imaging biomarker clinical trials in Oncology. * Experience applying PET imaging as a quantitative endpoint in clinical and preclinical studies in Oncology. * People management experience. * Direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers. * Strong background in oncology, biology, molecular imaging, radiopharmceuticals and familiar with precision medicine approaches. * Imaging CRO oversight and implementation of quality control procedures. To be considered for this role, you must have a PhD with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development). Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is required. We also are looking for you to have had successful engagement experience with regulatory agencies and the ability to champion imaging innovations and lead projects effectively. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00

We're seeking a Digital Health Technologies (DHT) Manager / Digital Health Project Manager to craft the future of clinical trials through innovative digital tools and technologies. In this role, you'll own the successful implementation of digital solutions-like eCOAs, eConsent, sensors, wearables, spirometry, and ECG-across clinical research studies. You'll partner closely with cross-functional teams to ensure high-quality execution and regulatory compliance while supporting strategy, process improvement, and vendor oversight. This is an opportunity to make a tangible impact on how data is collected, analyzed, and used across global development. A Typical Day: * Leading the implementation of digital tools for one or more clinical trials with accountability for quality and compliance * Defining and supporting study-level strategies for validating and maintaining eClinical technologies * Leading all aspects of digital vendor performance, including KPIs, root cause analysis, and issue customer concern * Leading project timelines, documentation, risk mitigation, and communication planning * Monitoring financial aspects and ensuring timely delivery of vendor outputs * Mentoring new team members and providing training to internal partners * Chipping in to the creation of standards and expansion of eSource modalities across studies This Role May Be For You: * You bring hands-on experience and understand the impact of eCOA on clinical trials * You're skilled at navigating vendor relationships and ensuring performance meets expectations * You thrive in cross-functional environments and communicate optimally with both internal teams and external partners * You enjoy balancing critical thinking with day-to-day project execution and problem-solving * You're proactive, organized, and comfortable leading multiple timelines in a regulated setting * You value process improvement and want to give to digital transformation in clinical development * You stay current with trends in digital clinical technologies and can advise on benefits, risks, and costs To Be Considered: You'll need proven experience with digital tools and technologies in a clinical research setting-especially eCOA systems development processes-and a strong grasp of ICH/GCP guidelines. Proficiency in project management, vendor oversight, and trial systems is required. Experience in strategic planning, partner communication, and innovation implementation is highly valued. Familiarity with Microsoft Project Server and prior success in cross-functional team leadership are preferred. Up to 25% travel may be required. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00

Regeneron is looking for a manager to join our HCP Engagement Operations team, specializing in Sponsorships & Joint Working. In this role, you will coordinate operational management of sponsorships and joint working activities across international markets, ensuring alignment with company policies, regulatory requirements, and industry standards. Your work will contribute to operational excellence, compliance, and continuous process improvement, making a meaningful impact on healthcare community partnerships. If you're ready to collaborate globally, manage vendors effectively, and drive operational success, we invite you to apply and be part of our dynamic team. A typical day may include: * Responsibility of sponsorship and joint working requests, approvals, and contract execution to ensure compliance with company policies and regulatory standards. * Managing and updating contract templates, coordinating amendments, and collaborating closely with legal teams for third-party contracts. * Coordinating sponsorship activities involving healthcare professionals, ensuring timely execution and adherence to local regulations. * Collaborating with external vendors to supervise performance and track agreed SLAs and critical metrics. * Forecasting and supervising budgets to support operational efficiency. * Serving as a point of contact for internal collaborators regarding sponsorship and joint working inquiries. * Ensuring accurate documentation and audit readiness across all processes. * Supporting the development of standardized processes, templates, and tools to streamline operations. * Partnering with cross-functional teams to analyze program effectiveness and identify optimization opportunities. This role may be for you if you: * Have experience managing contracts, templates, and external vendor relationships in an operational setting. * Are skilled in budget management, reporting, and workflow optimization within a regulated environment. * Are proficient in CRM or event management systems and comfortable with data tracking and analytics. * Excel at collaborating in a matrixed organization and managing partners across geographies and cultures. * Have a solid understanding of pharmaceutical sponsorship processes and regulatory requirements. * Possess strong organizational skills, attention to detail, and proactive problem-solving abilities. * Thrive in fast-paced environments and can prioritise effectively. * Are passionate about driving operational excellence and maintaining compliance. To be considered: You must have a Bachelor's degree in Business, Life Sciences, or a related field, along with 3-5 years of experience in HCP engagement operations, sponsorship management, or commercial/medical affairs support within the pharmaceutical, biotech, or life sciences industry. Preferred qualifications include experience with CRM systems, event management platforms, and a strong familiarity with industry codes like EFPIA and ABPI, as well as GDPR compliance. Join us in making a difference in healthcare through transparent, compliant, and impactful sponsorship operations. Apply today! Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Global Development (GD) is embarking on a digital transformation project that will incorporate AI, machine learning, and automation into our processes to help us reduce cycle times, improve quality, and allow us to focus on more meaningful work. This position will play a key role in developing the platforms, processes and technologies that will incorporate AI effectively across GD. The AI engineer will work with a team of engineers and scientists to help bring transformative change to GD. The role will encompass a wide range of AI/ML-related activities, from data engineering and technical development to optimizing vendor systems for use at Regeneron to mentoring colleagues in best practices for adopting and AI in their everyday workflows. Development will not necessarily be limited to the use of generative AI, but may also include technical implementation of machine learning models, natural language processing, and other approaches. The engineer will work with stakeholders across GD and Regeneron (e.g. enterprise IT, commercial, research, etc.) to develop solutions and architectures that not only address GD's needs but also integrate into the overall corporate strategy. As a Senior Manager, a typical day may include: * Implement, and refine novel algorithms and scalable AI /ML solutions tailored to GD applications such as clinical trial design, regulatory intelligence, patient identification and stratification, etc. Deploy these solutions to production environments as appropriate Implementation includes hands-on development and coding. * Develop, implement, and improve data architecture and engineering approaches for diverse data sources across GD * Contribute to initiatives with GDIT and enterprise IT to build the necessary infrastructure (software and hardware) to support advanced analytics * Collaborate with GD colleagues to help them approach AI/ML more effectively * Establish rigorous validation frameworks for AI models and monitor existing models for accuracy and efficiency * Stay up to date with the latest advances in the field and, as appropriate, evaluate them for adoption at Regeneron To be considered for this opportunity, you must have the following: * Deep understanding of generative AI, machine learning, natural language processing, and statistical modeling * Deep expertise in programming (Python, R, etc.), with a focus on applying advanced technical skills to data analysis, pipeline creation, automation, and software development * Expertise in database platforms and cloud computing infrastructure * Track record of model development, implementation to scale, maintenance, and evaluation in a healthcare of life sciences setting * Experience managing and analyzing large-scale clinical datasets * Excellent communication skills, both technical and non-technical * Experience managing multiple projects * Experience working in cross-functional teams * May require travel up to 20% Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

We are seeking a motivated **Laboratory Equipment IT Engineer** to support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems that support Clinical Manufacturing and Research and Development (R&D). This role is a part of Regeneron Cell Medicines (RCM), a newly formed R&D unit within Regeneron to advance cell therapies and combination approaches in oncology and immunology. We hope you are excited to serve as the technical SME as well as operate at the system administration, engineering, and management levels. **As an Laboratory Equipment IT Engineer, a typical day might include the following:** + Supporting all manufacturing and QC equipment within RCM's 30,000 SF Phase 1 clinical manufacturing facility + Maintaining System documentation, including converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans, and summary reports + Leading IT Applications systems security access and periodic audit trail reviews + Performing investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software + Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements + Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, as well as generating and implementing necessary FAT and SAT protocols + Designing and developing test plans and implementing software/hardware improvements to automated process control and process monitoring equipment according to change control procedures + Ensuring systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO; perform recovery of data as needed + Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing + Ensuring systems remain in compliant state including process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments + Supporting system integration with existing systems (ex. LIMS, Historian) as required by business needs **This role might be for you if you:** + You enjoy working in a fast-paced environment and can be flexible with changing priorities + You thrive in a team-based, multi-functional, collaborative environment + You possess a problem-solving mentality + You have excellent verbal and written communication skills **In order to be considered for this role,** you must have at least a Bachelor's degree in Information Technology or related field and 3-5 years of relevant experience in a manufacturing/lab/IT setting. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility. Must have experience with automated systems for environmental monitoring and compliance; Rees is preferred. Experience working in a GMP environment is very advantageous. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $79,100.00 - $129,100.00

Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the Health Authority. A typical day might include: Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management. Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities. Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics. Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections. Direct and provide advice on the compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines. Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals. Provide leadership by contributing to departmental strategy, organizational goals, and policy development. Guide team members to address complex and unprecedented program challenges, ensuring timely resolution. Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures This Role Could Be a Great Fit If You Have: Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage. Strong understanding of current CMC / CP worldwide regulations. Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs. Previous experience with device regulatory requirements and development processes for combination products is an advantage. Human Factors experience is a plus. Experience in dealings with the FDA and other regulatory authorities. Experience managing and developing staff members. In order to be considered for this role, you must have: A bachelor's degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including a minimum of 8 years of relevant CMC experience. Alternatively, a master's degree with 8+ years of experience, or a PhD degree with 3+ years of experience. At least 3 years of applicable managerial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $172,200.00 - $286,900.00

We are looking for a Senior Group Director in Quantitative Pharmacology. This individual will be responsible for managing a team functioning in one or more therapeutic focus area. In this capacity the SGD is accountable for the successful and timely completion of QP related activities, encompassing a broad array of deliverables in support of Drug Safety and Pharmacometrics. The successful applicant will support a range of assets from Early Clinical Development through submission and beyond. This position can be based in our Tarrytown, NY, Warren, NJ or Cambridge, MA offices. A day in the life of a Senior Group Director may look like: * Managing and mentoring a broad spectrum of individual contributing scientists. * Providing technical guidance and mentoring of colleagues within the function and across the organization. * Performance management and assessment of staff and providing guidance and training to enable their success. * Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively developing and implementing strategic analyses in support of research and development projects. * Taking accountability for the PK/PD evaluation of a portfolio of products or projects, and/or highly complex projects that are wide in scope. * Identifying opportunity for process and procedural improvements, product or service improvements. * Solving unique and complex problems that have a broad impact on the business. This may be the right role for you, if you: * Can inspire and lead colleagues to deliver PMx and company goals. * Want the ability to make a significant impact on the organization and external groups, and can influence and effect change. * Enjoy making contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge. * Understand long-term career opportunities and can guide other QP staff on potential directions. In order to be considered qualified for this role, you must have: * 10+ years of industry experience (with a Ph.D.) or 12+ years (with an M.S.), focusing on modeling and simulation, PK/PD (pharmacokinetics/pharmacodynamics), systems pharmacology, and quantitative drug development strategies. * Hands on usage of a broad range of quantitative tools and systems is required, as is a strong publication record in the field. * A proven ability to display excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly. * Strong collaborative skills and effective at building alliances across functions, as well as the ability to effectively influence colleagues and multi-disciplinary project teams. * The ability to handle all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects. * Proven experience interacting with regulatory agencies without supervision, and within the company to develop regulatory strategy. #REGNQPCP Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $238,400.00 - $397,300.00

This role requires 4-days onsite per week in one of office locations. This role is NOT eligible to be fully remote. The Senior Manager Site Start Up Business Services will play a pivotal role in supporting the Site Start-Up (SSU) team by identifying, implementing, and optimizing solutions that enhance business efficiency and effectiveness. This role will focus on analyzing current processes, introducing innovative tools and technologies, and fostering cross-functional collaboration to streamline SSU operations and achieve organizational goals. A typical day in this role looks like: System and Tool Management: * Ensure that SSU tools and systems are effectively supporting business operations and meeting team needs. * Work closely with stakeholders to identify opportunities for improvement and ensure tools are aligned with organizational goals. * Coordinate updates and enhancements to existing tools to improve workflows and address evolving business needs. * Provide guidance and support to the SSU team in using tools effectively, helping resolve any challenges they encounter. Business Needs Assessment: * Collaborate with SSU leadership and teams to identify gaps, challenges, and inefficiencies in current processes. * Gather requirements and feedback from stakeholders to prioritize tool and system development efforts, ensuring alignment with SSU objectives. Innovation and Development: * Use creativity and problem-solving skills to design and propose innovative tools and solutions that address business needs and improve process efficiency. * Partner with GDIT, DADs teams, or other relevant departments to develop and implement new tools and systems that drive operational excellence. * Ensure new solutions are scalable, user-friendly, and aligned with SSU goals and industry standards. Reporting and Analytics: * Maintain and improve existing SSU reports, ensuring data accuracy, relevance, and actionable insights. * Develop new reporting mechanisms to support data-driven decision-making and process optimization. Collaboration and Communication: * Serve as the primary point of contact between SSU and technical teams, ensuring clear communication of requirements, timelines, and priorities. * Facilitate training and user adoption for new tools and systems within the SSU team, fostering a culture of continuous improvement. Continuous Improvement: * Drive continuous improvement by proactively shaping Veeva solutions and other Regeneron tools to create strategies to align with evolving industry standards and regulations, ensuring sustained compliance and strong operational performance. * Stay updated on industry trends and emerging technologies relevant to SSU operations, recommending enhancements to tools and processes to ensure efficiency and effectiveness Leadership & Team Collaboration: * Lead and support meetings, sending meeting invites, setting agenda, creating minutes, and following up with actions with cross-functional teams, as required. * Present to the Regeneron Steering Committee and request endorsement of system enhancements, as needed. * Manage, mentor, train and support other members of the team as required * May require up to 25% travel This role may be for you if you have: * Relevant experience with Clinical Trials, documents and responsibilities internal and external to the Sponsor * Relevant experience or familiarity with Veeva Vault Clinical modules and existing functionality * Subject Matter Expertise in CTMS, TMF and Organization/Person Profile Management * Ability to communicate complex issues to internal and external partners driving effective decision-making is required. * Ability to prioritize multiple important tasks and maintain high quality of work and appropriately communicate items that could impact timelines or quality is required. * Detail oriented collaborator with demonstrated ability to adapt to change is required. Proven experience in a multi-disciplinary environment is required. * Cross-functional Coordination Skills - ability to collaborate within own department/function as well as across departments to resolve issues is required. * Problem Solving / Decision-making - takes an active role in analyzing and synthesizing problems and issues is required. * Risk Management Skills - evaluating risks based on thorough business analyses is required. * Project Management - ability to take a leadership role in managing projects is required. * Advanced Excel skills (e.g., pivot tables, complex formulas, macros) are required. * Fundamental understanding of programming concepts (e.g., SQL, Python, or similar) is preferred. * Management of direct reports is preferred. In order to be considered qualified for this role, a minimum of a Bachelor's degree and 8+ years of relevant clinical trial experience is required. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $132,400.00 - $216,000.00

At Regeneron, we are dedicated to transforming lives through science and innovation. We are seeking a dynamic and entrepreneurial Haematology Commercial Leader to join our team in the UK & Ireland. This hybrid role blends sales and marketing expertise, offering you the opportunity to build the commercial success of our Haematology portfolio while adapting global strategies to meet local market needs. If you're passionate about driving impactful results and thrive in a collaborative environment, this role is for you. In this position, you'll play a pivotal role in adapting and implementing global brand plans, ensuring flawless cooperation across cross-functional teams, and championing Regeneron's values in everything you do. This position offers growth opportunities as the portfolio expands, making it an exciting time to join Regeneron. A Typical Day: * Develop and implement brand plans for the Haematology portfolio, aligning efforts and budgets with growth objectives and global strategy. * Adapt and gain approval for UK-specific materials derived from global resources, ensuring minimal changes while maintaining compliance. * Own the development of launch strategies, account planning, and commercial advisory boards to optimize market understanding and opportunities. * Build and implement National, Regional, and Local account plans with clear prioritisation and trade-offs to achieve commercial success. * Expand Regeneron's reputation and relationships with key healthcare professionals across therapy areas. * Collaborate with cross-functional colleagues to analyse market dynamics and trends, supporting brand and collaboration objectives. * Maintain the highest ethical and compliance standards while encouraging positive relationships with internal and external stakeholders. This Role May Be For You If: * Are a self-starter with an ambitious mindset, capable of blending local strategy with global objectives while keeping things simple and actionable. * Thrive in a hybrid role that demands adaptability, prioritisation, and a hands-on approach to ensure commercial success. * Excel at building relationships and credibility with KOLs partners. * Possess excellent planning, communication, and presentation skills, and are comfortable navigating CRM systems and sales data. * Are willing to travel 30-40% of the time, including occasional weekends for conferences and meetings. * Have a passion for maintaining ethical standards and aligning with our values. To Be Considered: The ideal candidate will hold a BS/BA degree (Master's degree or advanced certifications preferred) and have over 10 years of biopharma experience, including proven success as a sales manager and marketer. Strong leadership and communication skills are crucial, along with proficiency in English (a second European language is advantageous). Experience in immunology or biologics and established relationships with oncology KOLs are highly desirable. Join us in making a meaningful impact in Haematology while advancing your career in a role that blends strategy, execution, and collaboration. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Program Operations Leader (POL) is 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). This individual is 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). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a 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) Provide input and operational insight into Clinical Study Concepts (CSC) Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Act as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drives the strategy and oversight for vendor selection and management within a clinical program(s) Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. #hematology Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00

The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: * 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 * We may ask you to 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 This role might be for you if can/have the: * Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments * Ability to work with a safety system database for purposes of medical case review and simple queries * Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize * Ability to effectively communicate (verbal and written) safety findings To be considered for this opportunity, you must have the following: * Minimum a Master's, PhD, or PharmD * Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

Are you ready to make a meaningful impact in the field of haem-oncology? At Regeneron, we are seeking a dedicated Medical Affairs Lead to be the driving force behind our haem-oncology program in multiple myeloma and lymphoma. As a pivotal member of our team, you will serve as the medical contact in-country, collaborating with internal teams and external stakeholders to advance scientific understanding, improve patient care, and ensure the success of our therapeutic strategies. Join us in shaping the future of haem-oncology while working in a dynamic and supportive environment. A Typical Day: * Represent Regeneron as the in-country medical contact for haem-oncology, engaging with medical societies, academic leaders, and thought leaders. * Collaborate with cross-functional teams, including clinical development, regulatory, market access, and commercial colleagues, to optimise strategic and tactical planning. * Manage and develop a high-performing haem-oncology medical team, ensuring compliance, training, coaching, and execution of initiatives. * Provide medical support for clinical development activities, such as identifying key investigators and supporting patient recruitment efforts. * Stay updated on scientific advancements and therapeutic developments in haem-oncology to enhance strategic decision-making. * Participate in scientific engagements and deliver impactful presentations to diverse audiences, including healthcare professionals and stakeholders. * Lead medical education initiatives, ensuring alignment with local needs and compliance with ABPI and IPHA codes. * Collaborate with global teams to prepare for product launches, market access strategies, and life cycle management initiatives. This Role May Be For You If You: * Are a physician (M.D.) or scientist (PhD) with expertise in haem-oncology and experience in Medical Affairs within the pharmaceutical or biotech industry. * Have a strong knowledge of ABPI and IPHA codes, coupled with experience supporting research and clinical development in the UK. * Excel at building relationships with key stakeholders, including thought leaders, and can cultivate trust through scientific expertise and follow-through. * Possess strong leadership skills, inspiring and motivating teams while fostering collaboration and inclusion. * Are proactive, resourceful, and thrive in a fast-paced, innovative environment. * Are skilled at juggling multiple projects, delivering actionable insights, and maintaining attention to detail. * Embody an entrepreneurial attitude and demonstrate a commitment to ethical and scientific standards. * Are fluent in English and willing to travel 30-50% of the time. To Be Considered: Applicants must hold an M.D. or PhD with expertise in haem-oncology and have substantial pharmaceutical or biotech industry experience in Medical Affairs. A thorough understanding of the UK healthcare environment and ABPI/IPHA codes is essential. Preferred candidates will have experience supporting clinical development in haem-oncology, a solid background in life-cycle product development, and a proven ability to work cross-functionally in matrix environments. Strong leadership, communication, and organisational skills are critical for success in this role. Join Regeneron and contribute to advancing haem-oncology care while working with a team of passionate professionals dedicated to innovation and patient outcomes. Apply today to make a difference! Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Regeneron's growing portfolio is accompanied by ever-increasing amounts of research and clinical data. We are seeking a leader in advanced analytics who can harness the power and insights within our data to improve Global Development (GD), making it more productive while delivering medicines to patients more efficiently and rapidly. Working with a team of data scientists, this position will develop both strategic and technical approaches to improve data access and quality; develop and implement AI/ML algorithms for predictive and descriptive analytics; and advise the GD organization on its overall data strategy. This position will be a key leader in GD's Digital Transformation (DT) efforts and will work closely with the DT lead to address scientific and informatics challenges. This position will also be a liaison between the DT group and the broader scientific community in GD and all of Regeneron. As a Senior Director, a typical day may include: * Establish and implement advanced analytical strategies to extract maximum value from our data. This may include answering clinical questions, using predictive analytics in trial design, automating document analysis and generation, automating development processes, etc. * Supervise the development of prototype systems and approaches that, in partnership with IT, can scale to be used on an enterprise level * Lead a team of data scientists and developers to create the technical tools and pipelines necessary to implement advanced analytic solutions * Drive the development and implementation of cutting-edge analytic solutions, fostering seamless integration and strategic alignment across GD and other Regeneron business units (e.g., Commercial, Research, etc.) to enhance data-driven decision-making and organizational synergy. * Collaborate with external partners (vendor, academic, scientific, etc.) to develop and implement relevant solutions * Provide scientific and informatics leadership to GD's digital transformation strategy with an additional focus on organizational change management. Proven ability to lead organizational change, particularly in adopting new technologies and processes, is a plus. * Present the advanced analytic strategy to diverse stakeholders across GD and Regeneron and have the ability to influence senior executive leadership and non-technical audiences * Develop KPIs to demonstrate the impact of advanced analytic strategies on GD cycle times and other relevant outcomes To be considered for this opportunity, you must have the following: * Proven track-record of developing and scaling advanced analytic solutions and advanced analytic strategies and programs in a healthcare or life sciences organization. * Demonstrated experience working with large-scale, complex datasets, particularly in the regulated healthcare or clinical trial setting; understanding of clinical data standards is preferred. * Demonstrated experience leading teams and overseeing multiple analytical projects, with a focus on guiding the development and implementation of AI/ML solutions. * Proven ability to develop and align data strategies that optimize data utilization, support organizational goals, and drive actionable insights. * Expertise in Python, R, or other programming languages, with a focus on applying advanced technical skills to data analysis, automation, and software development. Candidates should demonstrate proficiency in writing efficient, scalable, and maintainable code. * Proven expertise in evaluating and validating advanced analytic algorithms, ensuring accuracy, reliability, and reproducibility in clinical and research applications. Skilled in developing frameworks for model validation, enhancing data quality, and implementing quality assurance protocols. * A research track record with academic publications and/or academic grant support is preferred. * Strong analytical and communication skills. * May require travel up to 20%. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $238,400.00 - $397,300.00

The Senior Clinical Study Lead (CSL) is expected to 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. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. (Armonk, NY / Warren, NJ / Cambridge, MA / Dublin, Ireland / Uxbridge, London) A typical day in this role looks like: * 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 This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. A background in clinical trials within cell therapy is highly preferred Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is 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). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: * Be responsible for the overall success of the clinical study team(s) within a 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) * Provide input and operational insight into Clinical Study Concepts (CSC) * Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM * Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate * Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). * Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation * Be 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. To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00

Global Development is embarking on a digital transformation project that will incorporate AI, machine learning, and automation into our processes to help us reduce cycle times, improve quality, and allow us to focus on more meaningful work. The Senior Manager, Advanced Informatics will play a key part in facilitating that transformation, linking clinical operations with technology. This position will provide strategic guidance while working with diverse teams to ensure that Regeneron can extract the maximum value from its data resources in developing AI/ML based solutions. This person will also play a major role in analyzing our data, communicating the results of the analysis, and implementing changes based on those results. This position will combine both scientific and technical knowledge to develop approaches and architectures for digital transformation while aligning with similar efforts across Regeneron. They will also work with external partners and organizations to maintain and improve data quality and to broaden the use of data standards throughout our processes. As a Senior Manager, a typical day may include: * Help develop and implement the clinical informatics strategy to optimize Global Development's data resources for AI/ML and advanced analytics * Provide strategic and operational guidance to data engineers and architects, including technical and application development related to GD data resources * Collaborate with teams across GD to identify clinical informatics use cases and implement solutions. * Organize and analyze diverse clinical data sets to solve specific GD-related questions and identify opportunities to increase efficiencies * Scale AI/ML and informatics projects to the enterprise level with cross-functional teams * Work with external data partners to optimize data standards for ingestion and exchange * Work effectively between technical and non-technical groups in Development and across Regeneron to bridge science and technology and implement a comprehensive data strategy * Evaluate tools and platforms and contribute to build vs. buy decisions * Inform and educate colleagues across GD regarding clinical informatics To be considered for this opportunity, you must have the following: * Proven track-record of developing and scaling advanced analytic solutions and advanced analytic strategies and programs in a healthcare or life sciences organization * Preferred: formal training in biomedical informatics or the equivalent experience * Demonstrated experience working with large-scale, complex datasets, particularly in the regulated healthcare or clinical trial setting; understanding of clinical data standards is preferred. Experience with electronic health record (EHR) data is also preferred. * Demonstrated experience architecting and building analytic pipelines, including those focused on data quality * Deep knowledge of AI/ML -based analytic approaches and strategies, including experience programming in Python, R or other equivalent * Experience leading multi-disciplinary teams including partnering with local or enterprise IT organizations * Strong analytical and communication skills * May require travel up to 20% Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials. In this role, a typical day might include the following: Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections. * Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders. * Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection. * Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups. * Identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector. * Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs. * Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide. * Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders. * Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners. * Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics. This role may be for you if have: * Advanced knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities. * Extensive experience with participating in, and supporting, Regulatory Agency Inspections of Investigator Sites, Sponsors and Clinical Research Organizations (CROs) in a GxP environment, including inspection preparation, facilitation, and follow-up. * Effective management of interpersonal relationships, stakeholder engagement, and collaborations. * Demonstrated ability to interface and collaborate effectively with other Managers and Directors within, and external to, the organization. * Extensive experience in providing training and presenting information on key quality and regulatory compliance information. To be considered for this opportunity we are looking for: Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience. * Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). * Experience in training, supervising, line management, mentoring and development of staff, and leading a small team Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

The Senior Clinical Study Lead (CSL) is expected to 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. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: * 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 This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

We are Regeneron, a leading science-based biopharmaceutical company dedicated to transforming lives through ground-breaking medicines. Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases. As a Senior Manager, Regulatory Affairs (EU), you will play a meaningful role in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our innovative development programs in metabolism and ophthalmology. This is your chance to create a meaningful impact on patients' lives while collaborating with a team of elite scientists and regulatory professionals. In a typical day you will: * Develop and implement regulatory strategies for assigned programs in collaboration with global development teams. * Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states. * Lead regulatory activities such as CTA amendments, annual reports, and other key submissions. * Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making. * Review clinical protocols and study reports to ensure alignment with EU regulatory requirements. * Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies. * Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed. * Represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations. This role may be for you if you: * Thrive on developing and implementing regulatory strategies that drive innovation and compliance. * Have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA. * Are passionate about advancing groundbreaking treatments in metabolism and ophthalmology. * Excel in establishing relationships and influencing collaborators across diverse teams. * Are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents. * Enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals. * Are proactive in staying informed about emerging regulatory trends and guidelines. To Be Considered: You must have a minimum of 4+ years of regulatory experience focused on supporting products through clinical development. An advanced degree in a scientific field is required, and experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred. A consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial. Preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure. Strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners, are critical for success in this role. Join us in shaping the future of medicine while advancing your career in a dynamic, collaborative, and inclusive environment. Together, we can make a difference. Apply today to be part of our mission to transform lives. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.