Amylyx Pharmaceuticals

Role Description This Real World Evidence (RWE)/Health Economics (HEOR) Contractor role supports the RWE/HEOR Senior Director in leading RWE execution for pipeline assets. The role is fun and flexible with a mix of both study execution and data analytics. This person will be accountable for developing and delivering components of the evidence generation plan (including RWE and economic value evidence), and driving high-quality deliverables that inform internal decision-making during product development, pre-launch readiness, and lifecycle planning. The role is anchored to 1–2 priority pipeline assets/indications. This is a remote role based with flexible hours. We are currently seeking an individual with 20-30 hours of weekly availability with potential to increase hours in late 2026/2027. Responsibilities - Evidence strategy and planning: Maintain US RWE & HEOR plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs; translate strategy into actionable workplans, timelines, and resourcing proposals. - Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors. - Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts; ensure adherence to SOPs and high scientific/operational quality. - Analytic execution and statistics: Execute ad hoc analyses in clinical trial, claims and PCOR data as needed for ad hoc and protocol/SAP driven analyses. This may include feasibility or full protocol execution. - Governance, compliance, and capability building: Complete required training, adhere to company/department SOPs, and contribute to continuous improvement of processes that enable efficient planning, execution, and dissemination of RWE & HEOR deliverables. Qualifications - Master’s degree or PhD in epidemiology, health economics and outcomes research, public health, biostatistics, or related discipline. - At least 1+ years of experience in the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application. - Proficiency with SAS and/or R for statistical programming. Preference for experience in clinical trials OR claims data. - Expertise in RWE and study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols, reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with ICJME criteria. - Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences. Preferred Qualifications - Demonstrated success developing and executing health outcomes research plans and delivering high-quality data generation outputs. - Experience managing real-world data sources and vendors (e.g., claims, EHR, registries) and translating findings into actionable insights and value messages. - Demonstrated ability to influence without authority in a matrix environment, evidenced by aligning cross-functional stakeholders on objectives/trade-offs, documenting decisions, and driving actions to closure. - Experience in PCOR implementation and validation. Work Location and Condition 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 must have access to work in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location. Compensation The hourly 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. - Contractor Hourly Compensation Range: $55 — $90 USD Company Description Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – 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 are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

Role Description The Senior Director, Market Insights is a highly visible, enterprise-level leadership role responsible for defining and driving the end-to-end insights strategy to support U.S. commercialization and global expansion. The Senior Director will serve as the strategic owner of the insights function, ensuring that market intelligence, analytics, and evidence generation are fully integrated into corporate decision-making across the product lifecycle. Reporting into the Vice President, Commercial Operations, the Senior Director will act as a key advisor to commercial and executive leadership, shaping commercial strategy through forward-looking insights that inform launch readiness, lifecycle management, and portfolio prioritization. This role requires the ability to operate at both a strategy and operational level, building scalable capabilities and frameworks to support a multi-asset, multi-market organization. Responsibilities - Define and own the enterprise-wide market insights strategy, aligning U.S. and ex-U.S. perspectives to support global commercialization and long-term portfolio growth, ensuring readiness across multiple markets and stakeholder groups. - Lead and execute market research projects influencing key decisions related to product launch strategy, lifecycle planning, new product planning, and as necessary, key market access strategies; ensure project deliverables are actionable, archived, and accessible. - Lead cross-functional integration of insight, ensuring alignment across Marketing, Medical, Market Access, Regulatory, R&D, and Executive Leadership to support decision-making. - Build and scale the market insight’s function, including defining operating models, processes, tools, and governance to support increasing organizational complexity. - Oversee and evolve global competitive intelligence strategy, ensuring proactive identification and ongoing communication of market shifts, competitive threats, and strategic opportunities. - Partner with Business Development (BD) colleagues to rapidly build market assessments, competitive landscape modeling, value creation theses, and financial modeling to facilitate executive decision-making. - Drive development of advanced analytics capabilities, including integration of primary research, real-world data, and secondary data sources into a cohesive insight ecosystem. - Establish KPIs and measurement frameworks (customer engagement, brand tracking, etc.) to evaluate commercial effectiveness and inform ongoing strategic adjustments. - Lead external partnerships and vendor strategy, including selection, governance, and optimization of research and analytics partners. - Develop and mentor future capabilities, including team build-out as the organization scales. - Lead insights efforts with a focus on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Qualifications - Bachelor’s degree required; advanced degree (PhD, MD, PharmD, or MBA) preferred. - 12+ years of experience in pharmaceutical or biotech market research, insights, or analytics, with increasing levels of responsibility. - Proven experience generating insights across the product lifecycle, including early-stage development, launch, and post-launch optimization. - Demonstrated expertise in competitive intelligence, including conference coverage and strategic synthesis of competitor activity. - Strong understanding of global market dynamics, including U.S. and ex-U.S. commercialization considerations. - Experience building or scaling capabilities, functions, or operating models. - Advanced analytical and strategic thinking skills, with the ability to translate complex data into actionable, enterprise-level decisions. - Exceptional communication and executive presence. - Experience in endocrinology is preferred. - Strong vendor management, budget oversight, and project management skills. - High degree of initiative, curiosity, and comfort with ambiguity in a fast-paced, mission-driven environment. Work Location and Conditions - Preference will be given to candidates residing in the Boston area or elsewhere on the East Coast. - Amylyx supports remote work opportunities within the United States, but cannot hire employees who reside and/or work in certain states (currently not considering applicants from Alaska, Arizona, Hawaii, Michigan, and Tennessee). - Travel to the corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. - Must have access to work in a setting that 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: $257,000 — $289,000 USD Equal Opportunity Employer 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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Associate Director, HCP Marketing will be a critical member of the Marketing team and will be responsible for leading the healthcare professional (HCP) engagement strategy to support the launch of avexitide for post-bariatric hypoglycemia (PBH). This role will focus on identifying, understanding and engaging key HCP segments, including thought leaders and early adopters, to build awareness of PBH and the role of avexitide in its treatment. This individual will partner closely with the sales force and field-facing teams, including Thought Leader Liaisons (TLLs), to ensure aligned, educational, and impactful engagement with the HCP community. Through the development of targeted promotional strategies and educational initiatives, this individual will help shape the HCP understanding of PBH, drive informed clinical dialogue and support successful product adoption at launch. This is a unique opportunity for a strategic, collaborative, and results-oriented HCP marketer to build a high-impact engagement platform in a complex and underserved therapeutic area. Responsibilities - Lead the development and execution of the HCP marketing strategy to support the launch of avexitide in the U.S., with a focus on raising awareness and understanding of post-bariatric hypoglycemia (PBH) among key clinical audiences - Identify and prioritize HCP targets, including early adopters, influencers, and thought leaders, to inform segmentation, messaging, engagement strategies, and opportunities for advisory boards and speaker programs - Develop and deploy unbranded and branded educational materials and tools, speaker content and engagement tools across personal and non-personal channels to support HCP understanding of PBH and avexitide - Partner closely with the sales force and TLLs to align on field strategies, deliver compelling resources and ensure consistent and aligned execution across U.S. regions - Create field-facing resources, engagement tools and trainings (e.g., leave-behinds, visual aids, digital content, trainings, etc.) that support effective HCP conversations and reinforce key clinical messages - Lead the planning and execution of HCP-focused conference and symposium activities, including booth presence, branded and unbranded materials, and sponsored programs in collaboration with cross-functional teams - Drive the planning and execution of advisory boards and speaker program activities, including associated content development - Oversee tracking of budget accruals, forecasts, and actuals, and ensure successful and timely completion of projects within budget - Manage the end-to-end process for the development, review / approval, printing, and fulfillment of all HCP-facing materials - Help manage external agencies and partners to ensure timely, high-quality deliverables that meet agreed-upon objectives, key performance indicators (KPIs), timelines, and budgets - Ensure compliance with all Medical, Legal, and Regulatory (MLR) requirements in the development and deployment of HCP-facing materials - Leverage customer and market insights, claims, and performance data to develop insight-driven marketing strategy and content, continuously optimize programs and identify opportunities - for innovation Required Qualifications - Bachelor’s degree required - 8+ years of pharmaceutical or biotech experience, with at least 3 years focused on HCP Marketing - Proven success in developing and executing HCP engagement strategies - Experience supporting field teams and partnering with Sales, Field Marketing and Thought Leader Liaison to drive brand messaging and education - Demonstrated ability to translate complex clinical information into clear, compelling promotional messaging for HCP audiences - Strong project management and organizational skills, with the ability to lead multiple high-priority initiatives simultaneously - Effectively managing external partners, agencies and budgets - Navigate Medical, Legal, and Regulatory (MLR) review and approval processes - Strong communication, strategic thinking, relationship-building skills, and a results-oriented mindset Preferred Requirements - Advanced degree; PharmD preferred - Experience in rare disease or product launch environments - Familiarity in digital HCP engagement, thought leader strategy and clinically complex therapeutic areas 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 $193,000—$217,000 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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director, Trade & Channel Operations will be responsible for building Amylyx’s U.S. distribution and channel model from the ground up in preparation for a future commercial launch of our lead product candidate. This individual will architect the distribution strategy, create the operational infrastructure necessary for launch, and partner cross functionally to ensure Amylyx is fully prepared to commercialize with excellence. As a key member of the Market Access team, this role will influence launch readiness, customer service delivery, and ongoing performance across distribution partners. Responsibilities - Design and build Amylyx’s U.S. distribution model across specialty pharmacy, specialty distributor, and 3PL channels to support product launch - Lead contracting strategy for specialty pharmacies and distributors, including negotiating distribution and service agreements, fee schedules, data requirements, and service levels - Integrate distribution channels with service programs and field initiatives to enable a seamless customer experience - Collaborate with Supply Chain and Finance to support 3PL operations, including order‑to‑cash processes, inventory management, data exchange, shipping, returns, and chargeback management - Establish and manage noncommercial and free‑goods pharmacy operations - Forecast and model channel performance, assess specialty pharmacy throughput, and provide recommendations to ensure timely, reliable patient access - Develop distribution analytics including inventory visibility, service metrics, dispense data, time to therapy, and partner scorecards; lead specialty pharmacy QBRs - Partner cross‑functionally with Supply Chain, Quality, Compliance, Legal, Finance, Patient Services, and Commercial Operations to ensure operational alignment and launch readiness - Serve as a senior leader within Market Access, contributing to launch planning, forecasting, patient access workflows, and overall distribution strategy - Continuously optimize post‑launch distribution operations by driving root‑cause remediation, vendor KPI management, and process improvements informed by field and service feedback. Required Qualifications - Bachelor’s degree required - 12+ years of experience in biopharmaceutical trade and distribution, including leadership of specialty pharmacy and distributor channel networks - Prior product launch experience in the US market - Experience designing and implementing channel strategies for product launches - Proven ability to assess, manage, and influence channel partner performance to contractual expectations - Hands‑on experience with 3PL operations, serialization, state licensing, and compliant distribution processes - Demonstrated strength in contract negotiation, vendor management, and commercial channel operations - Deep understanding of payer reimbursement, hub/patient support integration, channel economics, and order‑to‑cash workflows - Proven leadership experience, including managing large pharmaceutical vendors, with demonstrated people management skills - Excellent communication, vendor management, analytical, and project execution capabilities 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 $255,000—$287,000 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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio. Reporting to the Senior VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives. The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity. In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives. Responsibilities - Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials. - Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations. - Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions. - Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines. - Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution. - Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners. - Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications. - Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists. - Identifies and implements process improvements and best practices within Clinical Development. Required Qualifications - MD required - Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred - Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution - Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment - Strong strategic thinking, problem-solving, and decision-making skills - Proven ability to interpret complex clinical data and translate insights into actionable strategies - Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts - Experience mentoring or leading team members preferred - 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 $315,000—$354,000 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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Vice President 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 12 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. 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 $330,000—$342,000 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 has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterprise‑level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP‑relevant computerized systems, with a strong emphasis on the Veeva Quality Suite. This role ensures that digital quality solutions and supporting systems meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), maintain data integrity, and enable a sustainable, inspection‑ready state across the organization. This person will partner closely with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, lead new system implementations and major enhancements, and drive harmonized, risk‑based validation practices. This role also oversees quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure, trend analysis, and effective governance through leadership of key forums including Quality Management Review and cross‑functional compliance meetings. Responsibilities Strategic Leadership & Governance - Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives. - Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance. - Oversee enterprise-wide governance programs, ensuring standardized, risk‑based approaches to system implementation and maintenance. - Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity. Computer System Validation & Lifecycle Oversight - Lead planning, execution, review, and approval of validation deliverables across GxP systems. - Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement. - Promote and reinforce CSA‑aligned, risk‑based validation practices to streamline compliance and maximize efficiency. - Ensure documentation quality and consistent application of SDLC principles across projects. Veeva Systems Expertise & Optimization - Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness. - Lead implementation, enhancement, and optimization of Veeva Vault modules and cross‑functional integrations. - Drive automation and digitization initiatives that improve usability, compliance, and system performance. - Partner with IT and Veeva administrators to maintain robust, compliant change control processes. Quality & Regulatory Compliance - Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations. - Author, revise, and own Quality System policies and procedures related to electronic systems and validation. - Represent Quality during internal audits, external regulatory inspections, and vendor assessments. - Lead timely remediation, effectiveness checks, and continuous improvement initiatives. - Provide oversight and trending for Quality Events related to system performance or compliance. Required Qualifications - Bachelor’s degree in a relevant scientific or technical discipline. - 8+ years of experience in the life sciences industry with strong GxP system experience. - Extensive leadership experience in cross functional implementation and validation of GxP computerized systems. - Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.). - Strong knowledge of global regulatory expectations and data integrity frameworks. - Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making. Preferred Qualifications - Expertise with SaaS/cloud architectures and database compliance expectations. - Understanding of clinical data collection technologies and supporting data processes. - Familiarity with SDLC, Agile methodologies, CSV vs. CSA principles and automated testing platforms. - Experience developing and interpreting Quality metrics such as KPIs and KQIs. - Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels. 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, which may include travel by air, driving or public transportation. - You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via 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 $170,000—$191,000 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. - Lead the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight. - Supports leading data management activities (i.e. DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases. - Performs UAT of systems and ensures appropriate plans and documentation are in place. - Leads the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review. - Manages external vendor compliance and quality checks. - Supports Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges. - Ensures databases adherences to SOPs, 21CRF Part 11, ICH-GCP and CDISC Standards (CDASH/SDTM). - Acts as a subject matter expert in leading technical initiatives and data management. Qualifications - Bachelor’s degree or higher in Life Science or related discipline - 8+ years of experience in clinical data management - Extensive experience with clinical data systems (particularly Medidata Rave) and languages like SAS, R or Python - Proven experience in clinical trial programming and database management - Knowledge of Clinical Data Standards such as CDISC CDASH, and SDTM - Provide strong support to Data Management - Experience creating advanced interactive data visualizations from raw data using multi-languages and applications such as SAS, R, Python, RShiny, Power BI, Tableau, Spotfire etc. - Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change. - Excellent written and verbal communication skills and organizational and documentation skills. Requirements - 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, which may include travel by air, driving or public transportation. - You must have access to work in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via 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: $183,000 — $206,000 USD

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Amylyx is seeking a highly motivated Associate Program Manager to provide hands-on project coordination support for the preparation of clinical areas of a New Drug Application (NDA) for a Phase 3 program. This individual will work in the Program Management department, reporting to the Director, Program Management. This is an exciting interdisciplinary role for a qualified and highly motivated individual. Responsibilities - Assisting in the management of cross-functional sub teams to facilitate timely planning, execution, tracking, and completion of NDA-related clinical deliverables. - Sub-teams may include individuals from the following functional areas: clinical development, clinical operations, safety, medical affairs, biometrics, regulatory, program management, etc. - Setting up meetings, drafting agendas and detailed minutes, and tracking actions through completion. - Assisting in the identification of issues impacting plan execution and working with the team to identify risks and develop mitigation strategies. - Ensuring effective and timely communication to sub-team members regarding activity status, key milestones, identified risks and resource allocation. Qualifications - MS or BS Degree in life sciences, healthcare, or related field. - Minimum of 3 years experience in pharmaceutical or biotechnology drug development with at least 1 year in a project/program management role. - Experience with clinical development phases is mandatory. - Experience in project management supporting cross-functional teams with strong organizational skills. - Proficiency in project management software and tools (e.g. Smartsheet, SharePoint or similar). - Excellent written and verbal communication. - Exceptional interpersonal skills and time management skills. - Extremely well-organized with the ability to manage highly detailed workflows. - Proactive and self-motivated with expertise in both planning and implementation. - Enthusiasm for working in a fast-paced dynamic environment with a sense of urgency. Requirements - 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 must have access to work in a 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 hourly 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. - Contractor Hourly Compensation Range: $48 — $55 USD Company Description Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait.