Amylyx jobs

THE OPPORTUNITY Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various internal and external stakeholders (e.g. Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions and post-submission strategies/preparation/defense. RESPONSIBILITIES * Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders. * Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges. * Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance. * Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences. * Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success. * Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually. REQUIRED QUALIFICATIONS * PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies. * Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards. * Proficiency in the design of clinical trials Phases I - III, in applying knowledge of general and cutting edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards. * Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE). * Prior experience in interactions with regulatory and health authorities considered a plus. 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.

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking a Medical Director, Clinical Development to be the lead for a late-stage, pivotal program that has the potential to expand to additional programs with the same molecule. This program may be the first of several for this molecule given the mechanism of action of the drug. Opportunities to lead additional development programs with other assets also may arise, together with leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring for assigned clinical trials, the development and implementation of the Clinical Development Plan for the assigned assets, including clinical study design and execution, as well as interpretation of study data. The successful candidate will interact within a multi-disciplinary, matrix work group including research, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall clinical development plans. You will be involved in potential translational activities, operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications. In this role you will interact with multiple functions and management within Amylyx, and with external stakeholders including the global medical expert community, global regulatory authorities, alliance partners and vendors. Responsibilities Provides medical monitoring to assigned clinical trials in the arenas of serious endocrine conditions. Provides clinical development leadership for programs that integrate extensive knowledge in clinical science and endocrinology, and inputs from the global medical and patient communities. Works closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans. Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP). Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels. Develops and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs). Acts as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs. Contributes to specific Business Development activities and various organizational initiatives in Clinical Development. Required Qualifications MD required Experience with late-stage clinical development and drug development in rare diseases strongly preferred 2+ years of experience in leading clinical development programs in the biotechnology/pharmaceutical industry with a proven record of achievements. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment. Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment. Excellent communication skills (oral and written) and organizational skills. Ability to travel internationally and domestically 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$249,000-$280,000 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.

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director of Clinical Pharmacology will provide leadership and support to the clinical pharmacology team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all drugs and drug candidates in development and, as applicable, through commercialization. As the clinical pharmacology expert within the company, you have experience and expertise in matrixed leadership and team management, and will lead, develop, and educate through cross-functional teams. In addition, there will be opportunities to contribute to diligence assessments. Reporting directly to the SVP, Head of Clinical Development, you will have high visibility at leadership levels, including with the Chief Medical Officer. You can efficiently and effectively synthesize internal and external data to produce a clinical pharmacology strategy. Responsibilities Serve as the clinical pharmacologist for the company across all clinical programs, providing strategic and scientific input from preclinical development through Phase 3 trials Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio from pre-IND through and post approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions Ensure appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program. Collaborates with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-human studies Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs Serves as the clinical Pharmacology expert across study and program teams Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs Contributes to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation Works closely with research and development teams and provides input into assay development, CRO selection and CRO management. Leads method development, method qualification, method validation activities as SME and sponsor monitor, as assigned. Represents nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities Creates or guides nonclinical and clinical pharmacology summary documents Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology; Authors/ reviews manuscripts for submission to peer-reviewed journals Required Qualifications PhD, PharmD, MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines Minimum 10 years of experience within the pharmaceutical and biotechnology industry with 5+ years' direct experience in Clinical Pharmacology Experience in an array of molecules including biologics, small molecules and gene therapy Demonstrated experience in writing, presenting, and discussing clinical pharmacology with regulatory authorities as well as other external and internal stakeholders Strong analytical skills and ability to interpret complex clinical data sets as well as deep understanding of individual patient data coupled with excellent written and verbal communication skills Ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs Strong technical proficiency in PK analysis (NCA and PopPK) Ability to work with an elevated level of integrity, accuracy, and attention to detail, while executing corporate objectives and goals Entrepreneurial, enjoys working in a fast-paced, small-company environment 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. 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 Medical Specialist I, Gastroenterology will report to the District Manager and will engage Gastroenterologists and other key customers within an assigned geography. We present clinically focused selling messages to create and grow revenue, consistently delivering product goals. The Medical Specialist will demonstrate strong and consistent sales performance that exceeds forecast and expectations related to product goals. We accomplish this in a compliant manner with a high degree of integrity strictly following all our policies and in compliance with all policies and procedures governing the promotion of pharmaceutical and biologic products in the US. Territory: Boston, MA A typical day may include: • Developing a strategy and implementing tactics within key accounts in the Gastroenterology therapeutic area generating product utilization. • Develop strong working relationships with Gastroenterology experts and others as well as nurses, office staff and other important health care personnel and key patient advocacy support groups. • Collaborate with our regional colleagues, other field-based home office teams to proactively address customer needs, market dynamics and trends. Develop strategies which support brand and corporate objectives within their assigned geography. • Participating in and help lead initiatives to support sales success as assigned (e.g. participate in industry-related local and regional meetings and medical conferences). This may be for you if you: • Can demonstrate advanced clinically based selling skills • Have proven success and positive track record of consistent sales performance in complex markets. • Experienced with customer segments operating within compliance guidelines • Are results oriented with a proven track record of success with product launches To be considered you must have a BA/BS in science or business (master's degree a plus). A minimum of 5 years' sales experience in the Pharmaceutical or Biotechnology industry. Previous gastroenterology or biologics experience preferred. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends Experience with in-servicing and training office staff, nurses and office managers Must be based in or located near the assigned territory (relocation will not be provided). Ability to travel (30-50%) 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) $143,500.00 - $187,500.00

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

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

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.

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. THE OPPORTUNITY As a key member of the Commercial Leadership Team, the Vice President, Commercial Operations will establish and lead the commercial operations function, ensuring the infrastructure, processes, and strategies necessary for successful product commercialization. This role oversees sales operations, forecasting and analytics, incentive compensation, market research, data management, CRM systems, field effectiveness, and commercial training. The leader in this role will act as a strategic partner across multiple functions, including Sales, Marketing, Market Access, Patient Services, Medical Affairs, Finance, IT, and Compliance, to drive commercial excellence and business growth. This role offers an opportunity to shape the Commercial Operations function from the ground up, supporting a high-impact product launch and long-term business growth. RESPONSIBILITIES Commercial Strategy & Leadership Serve as a key member of the Commercial Leadership Team, developing and executing commercial strategy and operational plans. Oversee the design and optimization of commercial operations, including market research, forecasting, data analytics, sales reporting, and performance tracking. Develop a best-in-class commercial infrastructure that aligns with business objectives and supports pre-launch and post-launch activities. Lead Quarterly Business Reviews (QBR) and Board of Directors (BoD) process preparation, including performance reporting and insights. Partner cross-functionally with Marketing, Sales, Finance, Compliance, Market Access, and Medical Affairs to drive aligned strategic execution. Sales & Field Operations Design and implement field force structure, including sizing, territory alignment, and resource allocation. Oversee field effectiveness, including CRM system implementation, sales enablement tools, and customer engagement reporting. Develop and manage incentive compensation plans to motivate and retain top sales talent while ensuring compliance. Establish field insights and reporting frameworks, providing timely and data-driven recommendations to sales leadership. Support field training and development programs in collaboration with Sales Training teams. Market Insights, Analytics & Data Management Lead the development and governance of commercial data strategy, ensuring seamless integration and utilization of sales, claims, specialty pharmacy, and CRM data. Develop competitive intelligence, customer targeting methodologies, and KPIs to assess commercial performance. Design dashboards, analytics tools, and reporting mechanisms that provide actionable insights for leadership decision-making. Partner with IT and external vendors to build and maintain a commercial data environment (CDE) that supports sales forecasting, revenue tracking, and strategic planning. Operational Excellence & Budget Management Manage commercial operations budgets, ensuring efficient allocation of human and financial resources. Drive process improvements, system enhancements, and operational efficiencies to optimize commercial execution. Oversee congress and event operations, including commercial presence at industry meetings. Ensure compliance with industry regulations and internal policies in all commercial activities. REQUIRED QUALIFICATIONS Bachelor's degree required; MBA or advanced degree preferred. 12+ years in commercial operations, sales analytics, or related functions within the pharmaceutical, biotechnology, or healthcare industry. Experience in rare diseases, specialty pharma, or product launches strongly preferred. Proven ability to build and lead high-performing teams in a fast-paced, evolving environment. Strong business acumen with the ability to analyze complex data, forecast market trends, and drive strategic decision-making. Demonstrated ability to work effectively across multiple departments, influencing senior leadership and cross-functional teams. Experience with CRM systems, sales analytics, market insights, data governance, and incentive compensation design. Strong written and verbal communication skills, with experience presenting insights to executive leadership and board members. Ability to navigate ambiguity, prioritize initiatives, and implement innovative commercial solutions. 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. While this is a remote role, preference will be given to candidates who reside within New England and can attend meetings at our office in Cambridge, MA on an as-needed basis. 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. 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.

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is looking for a Director, Drug Substance, to join our CMC and External Manufacturing team. In this role you will be the technical development drug substance owner for Amylyx's Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. This position will work directly with external CDMOs to develop, scale-up, and validate drug substance processes. Initially this role will be an individual contributor, however, may evolve into a functional head. In this highly collaborative and visible role, you will be a key member of asset CMC teams. This role reports to the Senior Vice President, Global CMC and External Manufacturing. Responsibilities Lead CMC drug substance phase appropriate development activities to ensure Module 3 content that supports global clinical filings and registration plans Serve as the technical SME and process owner for drug substance. Working with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports Ensure robust regulatory plans for all changes while minimizing risk to product supply Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams. Update project timelines and budgets, communicate progress, and maintain the CMC program plan Regularly interacts with functional areas including Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development Manage external resources including Consultants and Contractors, as needed to deliver projects Travel to global manufacturing sites to support operations and validation activities Required Qualifications Bachelor's degree in organic chemistry, chemical engineering, or related field. MS or PhD preferred A solid understanding of small molecule, RNA, and amino acid chemistries At least 15 years of experience in API development from early through late-phase. Prior process validation experience preferred Experience developing oligonucleotide and/or synthetic peptide processes including impurity control strategies Experience leading global, cross-functional, high performing teams. Prior experience leading or serving on a CMC team preferred Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents A strong track record of successful global CMC submissions and approvals Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions to complex technical challenges Experience working with contract manufacturing organizations Excellent communication and teamwork skills Ability to travel internationally up to 10% 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. 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.

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

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. The Opportunity The Senior IT Leader for Commercial and Medical Affairs will be responsible for driving the strategic direction, implementation, and support of technology solutions that enable Amylyx's Commercial and Medical functions. This role ensures the delivery of scalable, robust, and compliant applications aligned with evolving business needs. You will lead the IT Commercial Business Partner team, collaborating closely with cross-functional stakeholders-including Supply Chain, Finance, and HR-to ensure technology initiatives enhance operational efficiency and support commercial success Responsibilities Build strong partnerships across business and technical teams to foster collaboration and effective project execution. Lead the implementation and support of Commercial and Medical business-facing applications, ensuring alignment with strategic priorities. Serve as the primary IT contact for audit and compliance matters related to Commercial and Medical systems, ensuring adherence to regulatory and internal controls. Establish and maintain IT processes and standards for application support within the Commercial and Medical domains. Oversee application enhancements and support activities in alignment with product launch and business objectives. Act as a functional and technical advisor to define, estimate, and propose solutions for business opportunities. Contribute to annual budgeting and planning for Commercial and Medical systems. Administer CRM platforms (e.g., Salesforce, Veeva) for Commercial and Medical Affairs teams. Manage vendor relationships, including assessments and contract negotiations. Coordinate issue resolution with internal teams and external service providers. Maintain the integration roadmap for Commercial and Medical applications (e.g., Commercial Data Environment, HUB, Aggregate Spend, Master Data Management). Lead RFP processes, evaluate proposals, develop ROI analyses, and ensure proper documentation for IT initiatives. Ensure compliance with regulatory requirements, including FDA computer systems assurance, SOX, and GDPR. Required Qualifications Bachelor's degree in Computer Science or related field. Minimum 10 years of progressive IT experience, including project and team management. 5+ years of experience with CRM and customer engagement platforms (e.g., Salesforce.com, Veeva). Strong understanding of service delivery and application lifecycle management. Familiarity with data privacy regulations and their application to business operations. Proven ability to lead cross-functional teams and manage external service providers. Experience with enterprise systems and software vendor selection. Excellent communication, analytical, and problem-solving skills. Ability to prioritize tasks and make sound decisions under pressure. Demonstrated success in managing IT projects within controlled change management frameworks. Strong customer service orientation and interpersonal skills. Self-motivated with high attention to detail. Preferred Equirements Experience in Life Sciences, particularly within high-growth pharmaceutical or biotech environments. Experience in Commercial, Marketing and/or Medical Operations within Life Sciences. Strong customer service orientation and interpersonal skills. Self-motivated with high attention to detail. Proficiency in managing SaaS-based application implementations. Strong analytical skills with the ability to translate business needs into technical requirements. Experience with commercial applications and data warehousing. Skilled in documenting and analyzing business requirements and functional specifications. Effective facilitator of team collaboration and group sessions. 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. This position is hybrid - we would like someone in the New England area who can come into the office on average 2 times per week - with some flexibility. 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. 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.

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

The Medical Specialist I, Gastroenterology will report to the District Manager and will engage Gastroenterologists and other key customers within an assigned geography. We present clinically focused selling messages to create and grow revenue, consistently delivering product goals. The Medical Specialist will demonstrate strong and consistent sales performance that exceeds forecast and expectations related to product goals. We accomplish this in a compliant manner with a high degree of integrity strictly following all our policies and in compliance with all policies and procedures governing the promotion of pharmaceutical and biologic products in the US. Territory: Boston, MA A typical day may include: * Developing a strategy and implementing tactics within key accounts in the Gastroenterology therapeutic area generating product utilization. * Develop strong working relationships with Gastroenterology experts and others as well as nurses, office staff and other important health care personnel and key patient advocacy support groups. * Collaborate with our regional colleagues, other field-based home office teams to proactively address customer needs, market dynamics and trends. Develop strategies which support brand and corporate objectives within their assigned geography. * Participating in and help lead initiatives to support sales success as assigned (e.g. participate in industry-related local and regional meetings and medical conferences). This may be for you if you: * Can demonstrate advanced clinically based selling skills * Have proven success and positive track record of consistent sales performance in complex markets. * Experienced with customer segments operating within compliance guidelines * Are results oriented with a proven track record of success with product launches To be considered you must have a BA/BS in science or business (master's degree a plus). A minimum of 5 years' sales experience in the Pharmaceutical or Biotechnology industry. Previous gastroenterology or biologics experience preferred. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends Experience with in-servicing and training office staff, nurses and office managers Must be based in or located near the assigned territory (relocation will not be provided). Ability to travel (30-50%) 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) $143,500.00 - $187,500.00

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

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: * Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study * Provides operational input into protocol development * Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. * Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. * Ensures compliance with the clinical trial registry requirements * Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors * Provides input into baseline budget development and management * Provides input into baseline timeline development and management * Leads risk assessment and identifies risk mitigation strategies at the study level * Leads the feasibility assessment to select relevant regions and countries for the study * Oversees/conducts site evaluation and selection * Leads investigator meeting preparation and execution * Monitors progress for site activation and monitoring visits and acts on any deviations from plan * Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan * Monitors data entry and query resolution and acts on any deviations from agreed metrics * Ensures accurate budget management and scope changes for internal and external studies * Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation * Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues * Oversees the execution of the clinical study against planned timelines, deliverables and budget * Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites * Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work * Ensure clinical project audit and inspection readiness through the study lifecycle * Supports internal audit and external inspection activities and contributes to CAPAs as required * Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability * Contributes to clinical study report writing and review * Facilitates and contributes to study level lessons learned * Assigns tasks to Clinical Study Management staff and supports their deliverables * Recommends and participates in cross-functional and departmental process improvement initiatives * Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs * May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring * Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight * May require 25% travel This role may be for you if you have: * Exceptional interpersonal & leadership skills * Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies * Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving * Advanced communication skills via verbal, written and presentation abilities * Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization * Ability to influence and negotiate across a wide range of stakeholders * Strong budget management experience * An awareness of relevant industry trends * Ability to build, lead and develop productive study teams and collaborations * Applies advanced negotiation and interpersonal skills to vendor management * Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC * Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents * Knowledge of ICH/GCP and regulatory guidelines/directives * Advanced project management skills, cross-functional team leadership and organizational skills * Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. The Opportunity We are seeking an experienced Head of the Market Access Field Team to build and lead a payer and strategic account director field team for a new product launch. This team will be responsible for engaging U.S. payers and health systems to secure coverage and access to treatment for people living with a rare, serious, condition. This is a unique opportunity to shape market access strategies and programs, and to be part of a new commercial team build-out. Responsibilities Serve as a key contributor to launch planning and execution, with a focus on access and reimbursement readiness. Build a high performing, strategic and collaborative account team. Design team structure including roles, target accounts, operating practices and incentives. Recruit, onboard, and develop the team through a successful launch. Lead and enable account teams to establish effective relationships at target public and private payers, PBMs and health system customers. Oversee and participate in customer payer PIE (Pre-approval Information Exchange) and clinical presentations, with the goal of securing favorable formulary access and coverage decisions. Partner with commercial leaders to implement solutions that quickly identify, escalate and resolve patient access issues during launch. Identify coverage and access opportunities and drive cross functional pull through efforts. Represent the market access strategy and payer voice with internal stakeholders as business decisions are made in a fast-paced environment. Foster a culture of trust, integrity and teamwork across all commercial functions. Hold team accountable to do the same. Required Qualifcations Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred. 10+ years of experience in Market Access. Must have experience leading a US payer field team at the national level, preferably in launch environments. Proven success in securing access for therapies in rare/orphan diseases is strongly preferred. Ability to inspire trust and drive alignment across cross-functional teams. Deep understanding of U.S. payer landscape, reimbursement pathways (including Medicare, Medicaid, and commercial), and policy environment. Ability to understand and present clinical disease state and product information. Strong analytical and financial acumen. This role requires up to 50% travel. 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. 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.

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

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create 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 determination, we encourage you to read the opportunity below and apply. THE OPPORTUNITY Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various internal and external stakeholders (e.g. Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions and post-submission strategies/preparation/defense. RESPONSIBILITIES Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders. Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges. Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance. Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences. Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success. Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually. REQUIRED QUALIFICATIONS PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies. Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards. Proficiency in the design of clinical trials Phases I - III, in applying knowledge of general and cutting edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards. Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE). Prior experience in interactions with regulatory and health authorities considered a plus. 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. 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.