Amylyx jobs - 28 jobs

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply. The Opportunity We are seeking an R&D and Preclinical Operations Specialist to provide operational and administrative support to a small, highly collaborative preclinical R&D team, including toxicology, bioanalytical, and research staff. This role partners closely with scientists and external vendors to support study execution by managing scheduling, documentation, vendor coordination, and procurement processes, enabling the scientific team to remain focused on execution and data generation. This is an excellent opportunity for an early-career professional interested in building a career in biotech operations, with exposure to preclinical development, CRO engagement, and cross-functional collaboration. Responsibilities Own day-to-day operational coordination and logistics for preclinical scientists, toxicologists, research associates, and bioanalytical staff. Partner with Procurement, Legal, and Finance to support vendor onboarding, contract initiation and life cycle management, purchase orders, and invoice tracking. Exercise judgment to coordinate competing priorities across R&D, ensuring study support planning activities are met by scheduling meetings, coordinating timelines, and tracking key milestones. Manage documentation systems related to operations of preclinical and toxicology studies, including protocols, reports, contracts, invoices and key communications. Ensure protocols, reports and data records meet audit-ready standards, drive continuous improvements in document tracking workflows. Maintain and continuously improve vendor record-keeping frameworks, ensuring contract status, statement of work and study related documents are proactively monitored. Own internal meeting operations, setting agendas in partnership with scientific leads, ensuring decision clarity, and tracking deliverables to closure. Support the Senior Director, Preclinical and Translational Sciences with calendar management, meeting preparation, and follow-up actions. Synthesize meeting outcomes into action plans and track execution. Manage budget tracking tools and prepare spend analyses for preclinical and toxicology activities in partnership with Finance and Procurement. Help establish and maintain operational processes, templates, and trackers to support a growing preclinical organization. Identify opportunities to improve efficiency and consistency across preclinical operations and administrative workflows. Required Qualifications Bachelor's degree in life sciences, business, or a related field. 1-3 years' experience post degree in a preclinical focused role with external contracts experience. Exposure to preclinical research, toxicology, bioanalytical sciences, or CRO environments, 1-2 years prior experience/exposure. Exposure concurrent with undergraduate work is acceptable. Familiarity with procurement, contracts, or vendor management processes. Proficiency with common business tools such as Microsoft Office. Experience with LinkSquares and/or Net Suite is a plus. Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment. Excellent communication skills and comfort working with both internal teams and external vendors. Proficiency with common business tools such as Microsoft Office. Experience with LinkSquares and/or Net Suite is a plus. Prior experience in an administrative, operations, or coordinator role within biotech, pharma, or life sciences is preferred. Work Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range $74,000 - $83,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

A leading biotechnology firm is seeking a Clinical Imaging Scientific Director for Oncology to lead imaging strategy and execution in clinical trials. The ideal candidate will have a PhD and over 10 years of experience in clinical imaging, particularly in oncology, with significant expertise in PET imaging and regulatory engagement. This role requires collaboration with research teams and overseeing imaging project implementation, contributing significantly to oncology drug development. Comprehensive benefits are offered to eligible employees. #J-18808-Ljbffr

The Director, Trade Relations is a field-based, National role, and is responsible for national coverage of wholesaler, specialty distributor and specialty pharmacy trade accounts and day-to-day channel to support the brand and field teams. We are seeking someone who can develop and maintain strategic relationships with key Trade customers to build rapport and increase Regeneron's competitive differentiation in the industry. A typical day may include the following: Management and oversight of partner activities to support sales, brand and marketing initiatives, reimbursement and access issues, including all activities related to: customer service; product handling and storage; inventory management; performance measurement for services provided by channel; audit support; recall effectiveness checks; and, resolution of field issues (i.e. problems reported from providers/pharmacies, distributors, related to service and product access). Negotiate and complete distribution contracts including oversight and management of renewals, terms of sale, revenue recognition, payment/collections for product sales with assigned wholesalers/specialty distributors (SD) and specialty pharmacy (SP) account base. Develop long term, productive and strategic business relationships with key decision makers from assigned supply channel partners to include all channel vendor options. Support processes to review and inspect channel partner facilities. Align processes with audit teams, quality initiatives and business growth planning. Assure vendor adherence to national regulatory and industry standards, i.e. Drug Distribution Accreditation, HDA standards Support Return Goods processing from Trade vendors per product policies, Company guidelines, and, contractual thresholds Collaborate with Regeneron Regulatory, Finance and Manufacturing partners regarding supply chain issues Facilitate the Alliance relationship with appropriate brands to assure optimal product access Responsible for developing long-term, productive relationships with industry relations and operations contacts at assigned accounts to insure optimal pull-through of products This role may be for you if: You have a Strategic approach and will implement and monitor the access, sales and Trade Relations strategies. You can develop deep account relationships with multiple partners within assigned account base and liaise with Alliance You possess the ability to analyze a wide variety of data including sales and financial data to make business decisions. You are able to travel 50-75%, and may be based in any US city, located within reasonable distance to an airport To be considered for this opportunity you should possess the following: A Bachelor's Degree and a Minimum of 15 years' experience in the pharmaceutical/biotech industry; Specialty or Biologics experience required. Minimum 15 years' experience Trade Relations with specialty distributor, wholesalers, specialty pharmacies required, retail channel experience is optional. Must understand pull-thru from script to fulfillment for Part B and Part D products working with channel vendors across this dynamic. Minimum 10 years of field or corporate management leadership position preferred. Additional broad-based experience valued: distribution and product operations, corporate partnerships, marketing, and/or sales management, and/or supply chain. Previous experience in launching new Specialty Pharmaceutical/Biologics products or indications. 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) $180,400.00 - $300,700.00

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. In this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff. This role might be for you if can: * Represent Biostatistics at Global Clinical sub-teams. * Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials. * Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc. * Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams. * Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools. * Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management. * Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. To be considered for this opportunity, you must have the following: * PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience * Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area. * Time to Event (TTE) experience. * Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies. * Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. * Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills. * Solid knowledge of statistical analysis methodologies, experimental and clinical trial design * Expertise in statistical software 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) $173,500.00 - $283,100.00

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

The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs). A typical day in this role looks like: * Organizes and delivers analyzable reports and metrics to the clinical study lead * Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings * Collates data for assessments such as feasibility and site selection and reviews site usability database * Contributes to review of study documents such as informed consent forms, case report forms and * facilitates study document reviews per company standard operating procedures * Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders * Collates materials for training and investigator meetings * Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan * Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings * Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance * Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form) * Manages and maintains team SharePoint and/or shared drive sites, as needed * Communication with sites as directed and maintains site contact information * Contributes to line listings review for Blind Data Review Meeting (BDRM) * May manage or contribute to oversight of Third-Party Vendors (TPV) * Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits * Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives * Proactively recommends process improvement initiatives for the department This role may be for you if you have: * Attention to details for the ability to track information and deliver on assigned study activities * Good communication and interpersonal skills; ability to build relationships internally and externally * Ability to be resourceful and to demonstrate problem solving skills * Demonstrate the ability to proactively assess information and investigate impact on clinical trials * Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Basic familiarity with medical terms and clinical drug development * Awareness of ICH/GCP In order to be considered for this role, a minimum of a Bachelor's degree of 2+ years' industry related work experience in a clinical setting. 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) $93,900.00 - $153,300.00

At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We are looking for a dedicated Manager QA to join our team in Uxbridge, UK. As a key member of the Quality Assurance Distribution (QAD) team, you will play a vital role in overseeing quality operations, managing storage and distribution activities, and ensuring compliance with regulatory requirements across the UK and European markets. This is your chance to create a meaningful impact on the quality and supply of life-saving products. A Typical Day: As the Manager QA, you will: * Fulfill Responsible Person (RP) duties to ensure compliance with the Wholesale Dealers Authorisation (WDA) licence requirements. * Oversee quality operations for distributor markets and marketing authorisation holder (MAH) activities. * Manage storage and distribution activities in the UK and European markets to ensure smooth product supply. * Support inspection readiness programs for Regeneron UK and affiliates. * Author and approve quality-owned Standard Operating Procedures (SOPs) for the QAD team. * Investigate and resolve temperature excursions in the UK and global markets, implementing corrective and preventive actions (CAPAs). * Collaborate with distributor market partners to ensure effective due diligence, qualification, and relationship maintenance throughout the product life cycle. * Provide subject matter expertise and lead quality assurance initiatives for product launches into new markets. This Role May Be For You If: * You thrive in dynamic environments and enjoy managing quality operations for complex supply chains. * You have a keen eye for detail, ensuring compliance with European Good Distribution Practice (GDP) and The Human Medicines Regulations 2012. * You excel at building and maintaining effective partnerships with vendors and distributors. * You are passionate about ensuring quality and regulatory compliance in pharmaceutical distribution. * You are skilled at conducting audits, managing deviations, and implementing CAPAs. * You are motivated by opportunities to contribute to product launches and supply chain projects. To Be Considered: You must have a Life Science degree, ideally in Chemistry or Pharmaceutical Science. Experience as a named Responsible Person (RP) on a licence (preferred). You have a strong knowledge of Quality Management Systems and their application in pharmaceutical or similar industries. You are familiar with the virtual supply chain environment and management of commercial products through the supply chain. Preferred qualifications include experience in audit management, vendor/customer management programs, document control, and pharmacovigilance systems. At Regeneron, we are committed to encouraging a diverse and inclusive work environment. If you are ready to take on an impactful role in quality assurance, we encourage you to apply today! 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.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking a Director, Launch Excellence to play a critical role in planning and executing the successful commercial launch of our first product in the endocrinology space. This role will be hired in 2026 and will partner cross-functionally to ensure launch readiness ahead of a potential 2027 product launch. The Director, Launch Excellence will serve as the central coordinator for launch activities-driving disciplined execution, clarity of ownership, and visibility across Commercial, Medical, Clinical, Regulatory, Manufacturing, Market Access, Finance, Legal, and IT. This is a hands-on role requiring strong project leadership, judgment, and the ability to operate effectively in a fast-growing biotech environment. Responsibilities Launch Planning & Execution Lead the end-to-end launch execution plan, including timelines, milestones, dependencies, and risk mitigation activities. Translate high-level launch strategy into actionable, trackable workstreams with clear ownership. Maintain and continuously refine integrated launch plans from pre-approval through post-launch phases. Cross-Functional Program Leadership Act as the single point of coordination across all launch-related functions. Facilitate regular launch governance forums (e.g., launch team meetings, executive readouts). Ensure continuous alignment across Commercial, Medical Affairs, Market Access, Supply Chain, Regulatory, and other key stakeholders. Readiness & Risk Management Proactively identify launch risks, gaps, and interdependencies; develop mitigation plans and escalate as needed. Track launch readiness metrics and ensure timely decision-making. Support scenario planning tied to regulatory timing, supply readiness, and market dynamics Tools, Process & Communication Implement and manage launch project management tools, dashboards, and reporting mechanisms. Drive consistent ways of working, documentation standards, and decision logs. Prepare detailed and clear executive-level communications and launch status updates Continuous Improvement Capture lessons learned and best practices to support future indications or lifecycle expansion. Help build scalable launch excellence capabilities appropriate for a growing biotech organization. Requirements Bachelor's degree required; advanced degree (MBA, MPH, MS) preferred. 10+ years of experience in pharmaceutical or biotech launch, commercial operations, or enterprise project management. Direct experience supporting product launch readiness in the U.S. market. Proven ability to lead complex, cross-functional initiatives without direct authority. Strong organizational, communication, and stakeholder management skills. Fluency with project management tracking tools (e.g., MS Project, Smartsheets, MS Excel), and advanced MS PowerPoint skills Comfortable operating in ambiguity and adapting as strategy and timelines evolve. Work Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis. When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range$212,000-$238,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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

Global Development Quality Governance and Oversight, Intern We are Regeneron, a leading science-based biopharmaceutical company dedicated to discovering, inventing, and developing medicines for serious medical conditions. Join us as a Global Development Quality Intern within our Quality Governance and Oversight group. This role offers a unique opportunity to support various sub-teams, including Quality Management and Quality Technology & Compliance, contributing to our mission of improving global health. As an intern, you'll gain hands-on experience in project management and quality systems, preparing you for a future in regulated clinical trials. A Typical Day: * Assist with managing documentation for Quality Partnership Oversight and process solutions. * Support the analysis and reporting of Key Quality Indicators and Corrective Actions. * Contribute to process improvement initiatives and workgroups. * Provide first-line support for the electronic Quality Management System. * Assist in inspection readiness and management forums. * Collect and report quality-related metrics and trends. * Act as a delegate for your supervisor when required. This Role May Be For You: * You thrive in a collaborative global team environment. * You have a keen eye for detail and a passion for quality. * You enjoy analyzing data and contributing to process improvements. * You are eager to learn and apply project management skills in a professional setting. * You are comfortable working with various stakeholders across different regions. To Be Considered: Candidates must be enrolled in a full-time program (Bachelor's, Master's, or PhD) in Life Sciences or a related field. You should be confident in your ability to work as part of a global team, with key stakeholders based in the US, UK, and Ireland. Preferred qualifications include experience with quality systems and project management. 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 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.

At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We strive to make a substantial impact on patients' lives by delivering innovative treatments and solutions. We are seeking a dedicated and detail-oriented Senior Specialist to join our International Commercial Operations team. In this pivotal role, you will oversee the day-to-day operations of the Review Committee Team, ensuring the flawless Medical, Legal, and Regulatory (MLR) review of promotional materials for all Regeneron products and therapeutic areas across Europe, Canada and Japan. Your work will uphold the highest standards of quality, integrity, and compliance with legal and regulatory requirements. This is an exciting opportunity to contribute to the evolution of content operations and make a meaningful impact on a global scale. A Typical Day: * Facilitate and manage Review Committee meetings to ensure compliance with policies, accurate outcomes, and timely incorporation of revisions. * Guide promotional material sponsors on review timelines and provide proactive submission guidance. * Collaborate with country marketing and medical teams to capture and implement business requirements on Veeva PromoMats. Staying updated on Veeva PromoMats features and incorporate them to streamline content review and approval. * Support the evolution of content operations from traditional approval processes to modular content creation and approval. * Actively participate in quality assurance checks and audits to ensure operational excellence. * Manage vendor communications, system updates, and improvements for content approval platforms. This Role May Be For You If: * You thrive in a collaborative environment and enjoy building positive relationships with diverse stakeholders. * You are passionate about operational excellence, ensuring timely and accurate project deliverables. * You have a proactive mindset, staying ahead of industry trends and incorporating innovative tools and processes. * You take pride in your communication skills and can effectively convey sophisticated ideas to various audiences. * You enjoy working with technology and are proficient in enterprise content management platforms like Veeva PromoMats and Aprimo. To Be Considered: We are looking for candidates with at least 5 years of professional experience, preferably in the healthcare or pharmaceutical industry, and a minimum of 3 years in commercial content review and approval operations. A bachelor's degree is required (or equivalent experience), along with proficiency in MS Office tools and content management platforms like Veeva PromoMats & Aprimo. Multilingual skills (e.g., Spanish, German, French, Italian, Japanese) are preferred but not mandatory. Applicants should also demonstrate strong project management abilities and a high level of attention to detail. 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.

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

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we're establishing new ways to think about science, manufacturing and commercialization. We are excited to invite applications for the role of Associate Director, Medical Operations within our Global Medical Affairs team. This pivotal position offers you the opportunity to lead and shape impactful externally sponsored research (ESR) programs, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency initiatives across diverse therapeutic areas in International Markets (Europe and Canada). Your work will directly support our mission of delivering innovative solutions while ensuring compliance with global regulatory standards. A Typical Day: * Lead the planning and execution of multiple ESR programs, ensuring alignment with internal and external collaborators, and ensuring adherence to GCP and other regulatory requirements. * Supervise Investigator-Initiated Studies (IIS) and Research Collaborations (RC) to ensure compliance and operational excellence. * Lead program budgets, timelines, drug supply and resources to meet organizational goals. * Collaborate with cross-functional teams and external vendors, including Contract Research Organizations (CROs) oversight, to drive program success. * Track and report program metrics, highlighting progress and areas for improvement. * Manage direct reports and workload distribution; Provide leadership and mentorship to team members, fostering their professional growth. * Drive continuous process improvements to enhance efficiency and compliance. This Role May Be For You If: * You are passionate about clinical research and have a strong background in Medical Affairs or related fields. * You have a proven track record to manage multiple c projects while maintaining attention to detail. * You are adept at navigating regulatory landscapes and ensuring compliance in all activities. * You enjoy mentoring and developing team members to achieve their full potential. * You are motivated by opportunities to innovate and improve operational processes. To Be Considered: Applicants must possess a minimum BA/BS degree in a related field, with a preference for advanced degrees or equivalent work experience. You should bring 14+ years of progressive proven experience, including 9+ years in clinical research, regulatory, or field-based functions within the pharmaceutical or biotech industries. A strong scientific background and expertise in Medical Affairs, Clinical Research, or related areas are highly desirable. Experience in therapeutic areas or antibody research is a plus. 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.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking a highly motivated professional with accounting experience who can apply accepted accounting principles and procedures to analyze financial information, prepare accurate and timely results, and ensure appropriate accounting control procedures. This position will be a key member of a cross-functional accounting team. The individual will be responsible for managing critical accounting areas, reconciliations, corporate accruals and ad hoc reporting. This position will have significant interaction with Amylyx business leaders. Responsibilities Month-End Close: Assist with the month-end close process to ensure timely, accurate, and complete financial reporting. Prepare journal entries for cash, investments, prepaid expenses, SG&A accruals, T&E, stock option exercises, and RSU vesting. Perform foreign currency translation and revaluation, ensuring accuracy of currency translation adjustments (CTA) and validation of exchange rates. Oversee the preparation and distribution of monthly financial reports to internal stakeholders. Ensure the preparation and review of intercompany journal entries and balances. Financial Reporting: Ensure internal financial reports are accurate, up to date, and aligned with business needs. Ensure compliance with financial reporting controls and maintain accuracy in reports used for internal control purposes. Prepare balance sheet reconciliations, ensuring completeness and accuracy. Prepare and oversee balance sheet and income statement flux analysis, comparing current periods with prior periods and the prior year. Lead the preparation and coordination of foreign statutory financial statements, including managing audits in collaboration with PwC. NetSuite and FloQast Management: Serve as the NetSuite administrator, responsible for maintaining accounts, departments, project codes, and GEO codes, ensuring approval processes are followed. Develop, enhance, and maintain NetSuite reports to support internal financial and operational needs. Oversee NetSuite cash reconciliation processes and identify opportunities to leverage additional modules. Administer FloQast by adding new users, assigning reconciliations, and maintaining the month-end close checklist. Lead user access reviews for both NetSuite and FloQast to ensure appropriate permissions are maintained. Tax & Treasury Support: Act as the primary point of support for the Head of Tax and Treasury, providing analysis and data for tax compliance and statutory reporting. Assist with the preparation and review of tax-related disclosures and support the tax filing process. Required Qualifications Bachelor's degree in Accounting or Finance 4+ years of progressive accounting experience Experience with ERP systems, particularly NetSuite Advanced proficiency with Microsoft Excel and other Office products Preferred Qualifications CPA designation or progress toward obtaining a CPA. Experience working in a public company environment or with a Big 4 accounting firm. Knowledge of international statutory reporting requirements and foreign currency transactions. Work Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range$97,000-$109,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

At Regeneron, we are dedicated to transforming lives through science. As a leading biotechnology company, we develop and commercialize life-changing medicines for people with serious diseases. Join our Global Procurement - International Markets: UK and France as a Senior Manager Indirect Procurement. You will partner with team members and colleagues from each market to implement and optimise plans for supplier engagement and sourcing priorities to achieve local commercial, medical, regulatory, and site objectives. While ensuring that market requirements for UK and France (regulatory, language, legal, commercial, medical, cultural, etc.) are understood and appropriately addressed. A typical day might include the following: * Enabling global priorities at a local level through partnership with Stakeholders and the Global Procurement organisation * Understanding of local in country market requirements and supply base Implementation of global category strategies to drive consistency in sourcing, contracting, and supplier relationship management in local markets. * Building processes and driving consistency and development across organisation * Reviewing local contracts for key areas of spend, and use data to monitor trends and patterns across spend at country level Partners with country stakeholders. * Execution of sourcing, negotiation and contracting activities in support of business needs * Driving value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities This role might be for you if: * You enjoy building effective, balanced, and long lasting work relationships with your internal and external stakeholders, suppliers, and partners * You enjoy leading/supporting cross-functional teams to get results through effective sourcing, negotiations, contracting, and supplier relationship management * You are comfortable providing expert insight and knowledge regarding rates, unit costs, and costing structures to enable efficient negotiations * You are used to looking at external data sources, market information, and supplier engagement to improve your organization's knowledge of supply market dynamics To be considered, you must possess a bachelor's degree in a relevant field of study and progressive experience in Indirect procurement, preferably including experience in Pharma/BioPharma. You have experience leading/supporting global categories teams, processes, and suppliers across a breadth of categories and a track record in building influential relationships with collaborators and suppliers to get results for your organization. You are confident at building influential relationships with collaborators and suppliers. You bring knowledge of contracting tools, ERP's, and eRFx systems (Oracle, Zycus, GEP, Ariba, Other). Proficiency in French is desirable. 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.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director, Marketing Excellence will play a pivotal role in shaping Amylyx's commercial strategy and driving seamless, integrated engagement across all customer touchpoints. This leader will be responsible for designing and executing a comprehensive, enterprise-wide omnichannel vision that connects with healthcare professionals and community members (patients and caregivers) through personalized, high-impact experiences. This role will integrate digital and traditional channels, leverage data-driven insights, and collaborate across functions to ensure alignment with brand objectives and launch plans. As a key strategic leader, you will shape how Amylyx engages customers, driving innovation and measurable impact. This role will also lead Marketing Operations with a focus on excellence across all aspects of Marketing. This is a unique opportunity for a strategic, forward-thinking marketer to define how Amylyx leverages technology, analytics, and creative storytelling to deliver consistent, high-value engagement. By combining strategic insight with flawless execution, this individual will help position Amylyx as a leader in omnichannel excellence within the life sciences industry. Responsibilities Lead the enterprise-wide digital and omnichannel vision for Amylyx, establishing the standards, principles, and operating model that guide customer engagement and other key audience across all channels. Develop and execute an integrated omnichannel marketing capability and strategy aligned with brand objectives and launch timelines, supported by a robust digital customer engagement capability roadmap. Define and optimize end-to-end customer journeys for HCPs and community members to ensure personalized, consistent experiences across personal and nonpersonal touchpoints, overseeing campaign execution across CRM, marketing automation platforms, and third-party media. Partner with brand teams to advise on the creation of compelling, compliant, audience-appropriate content while ensuring alignment with regulatory requirements. Collaborate cross functionally with Commercial, Medical Affairs, and Corporate Communications to ensure seamless integration and synergy across all customer-facing activities. Establish measurement frameworks with KPIs and dashboards to monitor engagement, conversion, and ROI, partnering closely with IT and analytics teams to ensure the data infrastructure supports real-time optimization. Drive continuous improvement by leveraging data driven insights to evolve strategy, enhance performance, identify new opportunities for customer impact and strengthen digital efforts across the organization. Oversee governance, optimization, and administration of marketing CRM, marketing automation, analytics platforms, asset management systems, and related martech tools. Oversee congress operations, material distribution, inventory, print/fulfillment, and speaker bureau operations and related budgets Develop procedures, documentation, and training to ensure compliant, efficient, and repeatable execution across Marketing. Requirements Bachelor's degree; MBA or advanced degree preferred 10+ years of marketing experience, with at least 5 years in omnichannel or digital marketing leadership roles within biotech/pharma; exposure to Corporate Communications channels is a plus Proven track record of developing and executing integrated marketing strategies for product launches Deep understanding of regulatory and compliance requirements in the life sciences industry Strong analytical skills and experience with marketing technology platforms (CRM, automation, analytics) Exceptional leadership, communication, and project management skills Preferred Qualifications Experience in rare disease Track record of success with product launches Work Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis. When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range$239,000-$269,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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