The Opportunity

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.

Required 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 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

The Position

Reporting to our Co-CEO’s, the SVP of Program Leadership & Development will drive the advancement of our clinical-stage pipeline. This individual will be responsible for end-to-end leadership of one or more key development programs translating scientific innovation into clinical, regulatory, and commercial success.

The SVP of Program Leadership & Development will play a critical role in shaping program strategy, guiding cross-functional execution, and maximizing asset value from early development through late-stage trials and potential regulatory approval.

This role will serve as a core member of the Senior Leadership Team, partnering closely with Clinical Operations, Medical, Regulatory, Biometrics, CMC, Commercial and other functional leaders to drive the successful execution of Amylyx’s development portfolio.

In a lean and evolving biotech environment, this individual will operate both as an enterprise leader and a hands-on program leader, directly supporting key assets while building a scalable program leadership organization over time.

The Opportunity

This is a unique opportunity to shape and define how program leadership is executed within a growing biotech organization at a critical inflection point.

Build a New Function from the Ground Up - design and implement a modern program leadership model, including the evolution from traditional program management to a strategic Program Lead and Program Manager structure.

Operate as a True Peer to Clinical and Medical Leadership - serve as an equal partner to senior leaders across Clinical Operations, Medical, and Regulatory, helping shape asset strategy and execution.

Drive Impact Across the Full Development Lifecycle - lead programs spanning early-phase IND-enabling work through Phase 3 and potential NDA submission, with direct impact on key value-driving milestones.

Balance Strategy and Execution in a Lean Environment - play a dual role as both a strategic leader and hands-on program leader, directly influencing outcomes while building for future scale.

Shape Organizational Culture and Ways of Working - establish a highly collaborative, accountable, and transparent operating model that strengthens alignment across functions and reduces organizational friction.

Scale with the Portfolio - build and develop a high-performing team over time, aligned to the growth of the pipeline and key clinical milestones.

Responsibilities

Strategic Program Leadership

• Partner with Clinical Operations and Medical leadership to define and execute development strategies and plans across programs
• Drive program-level decision-making, including risk assessment, trade-offs, and prioritization
• Ensure alignment between asset strategy, clinical execution, and regulatory pathways
• Present program updates, risks, and opportunities to Executive Leadership and Board of Directors

Cross-Functional Integration & Alignment

• Serve as the central integrator across Medical, Clinical Operations, Regulatory, Biometrics, CMC, Commercial and other key functions
• Drive clarity of roles, decision-making, and accountability across program teams
• Proactively identify and resolve cross-functional misalignment, gaps, and competing priorities

Hands-On Program Execution

• Directly serve as Program Lead for one or more key assets, particularly in the early phase of the role
• Lead cross-functional team meetings, execution planning, and milestone delivery
• Translate strategic objectives into clear, aligned execution plans

Build & Scale Program Leadership

• Design and implement a program leadership model, including Program Leads and Program Managers
• Hire, develop, and lead program leadership talent over time as the organization grows
• Establish best practices, governance frameworks, and ways of working that enable scalability

Portfolio & Executive Contribution

• Contribute to portfolio prioritization, resource allocation, and strategic planning discussions at the leadership level
• Provide clear, actionable insights and recommendations to executive leadership
• Support the evolution of Amylyx’s development organization as it scales toward key clinical and regulatory milestones

Required Qualifications

• Advanced degree (PhD, MD, PharmD, or MD) in a relevant scientific discipline preferred; equivalent experience in drug development and program leadership will also be considered
• 20+ years of experience in the pharmaceutical or biotechnology industry, including significant experience leading cross-functional drug development programs
• Lead integrated clinical development plans (CDPs)
• Overseen protocol design, endpoints, and trial execution
• Demonstrated success in regulatory interactions (FDA, EMA)
• Significant experience leading cross-functional drug development programs, ideally spanning early development through late-stage clinical and/or regulatory milestones
• Demonstrated success in regulatory interactions (FDA, EMA)
• Prior experience serving as a Program Lead, Development Team Leader (DTL), Asset Team Lead or equivalent role, with accountability for cross-functional program execution
• Demonstrated ability to partner with Clinical Operations, Medical, and Regulatory leaders as a peer, influencing strategy and execution
• Experience operating in a biotech or similarly lean, fast-paced environment, with comfort navigating ambiguity and evolving priorities
• Proven track record of building or scaling teams and/or functions within a matrixed organization
• Strong leadership and collaboration skills, with the ability to align diverse stakeholders and drive decision-making in complex environments
• Hands-on, execution-oriented leadership style, with willingness to engage directly in program delivery when needed
• Excellent communication and interpersonal skills, with the ability to bridge scientific, clinical, and business perspectives

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis.  Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• 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.

The Opportunity

We are seeking an experienced Associate Director, Contracts to refine and scale our contracting operations and review as we prepare for a potential drug launch. This role will own the full contract lifecycle process—from intake and template selection through, execution and post‑execution management, including negotiating certain agreements independently. This is a highly visible, customer‑service‑oriented role that will serve as the internal subject‑matter expert and trainer for Amylyx’s contract lifecycle management system (CLMS). The ideal candidate will have a strong background in contract management and negotiation within the life sciences, biotech, or pharmaceutical industry and thrive in a fast‑moving, evolving environment.

Responsibilities

Contract Management & Operations

• Optimize and implement contracting processes and best practices, ensuring efficient workflows, compliance, and continuity across teams.
• Manage end-to-end contract lifecycle for a broad set of contracts, e.g. services, confidentiality, research collaborations, and other commercial or operational contracts.
• Maintain the contract management system and repository, including metadata accuracy, key date tracking, renewal management, obligation monitoring, tags, parties and reporting.
• Partner closely with internal stakeholders (Legal, Compliance, Finance, Procurement, Clinical, Commercial, and other business partners) to ensure contract terms align with business and compliance needs.
• Develop, update, and maintain contract templates and playbooks in partnership with Legal advisors.
• Develop and maintain CLMS training materials and provide new hire and refresher training sessions as well as ad hoc support.
• Establish and track contracting KPIs, dashboards, and metrics to provide visibility into system performance and contracting volume.
• Partner with the IT Administrator to drive continuous contracting process improvements, including identifying opportunities to streamline workflows through automation and the use of Artificial Intelligence tools.

Contract Review & Negotiation

• Prepare and negotiate agreements independently or escalate non-standard terms to manager with potential positions.
• Develop and maintain contract templates and playbooks.

Required Qualifications

• Bachelor’s degree required; JD or Paralegal Certification preferred.
• 8+years of experience in contract management and with CLM system(s); experience independently negotiating contracts.
• Strong ability to prioritize, independently manage workload, and meet deadlines in a dynamic environment.
• Exceptional written, verbal, and interpersonal communication skills with a focus on customer service and excellent attention to detail.
• Proven ability to work with cross-functional teams and build strong internal relationships.
• Aligned with a patient‑focused mission and able to uphold the highest standards of integrity.

Preferred Qualifications

• Experience with LinkSquares contract lifecycle management system.
• Demonstrated experience applying AI tools to contract review or process optimization.
• Industry experience in biotech, pharma, or life sciences.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis.  Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

The Opportunity

The Director Clinical Science will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will report to a Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).

Responsibilities

• Collaborates with the clinical development team in review, analysis, and interpretation of study results.
• Provides scientific support on ongoing Phase I to III clinical trials and contributes to the planning and design of upcoming clinical studies.
• Performs monitoring and review of study data including labs, safety data, and patient eligibility.
• Authors and/or reviews clinical trial-related documents including protocols, CRF, informed consent, protocol deviations, monitoring plans and regulatory documents, etc.
• Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs.
• Interacts with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.

Required Qualifications

• Advanced degree (M.D., Ph.D., Pharm.D., Master’s Degree in Science/Medical-related field).
• MD, PhD or PharmD with 3+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master’s degree with 8+ years of relevant experience.
• Knowledge of Phase 1-3 drug development.
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
• Prior experience working within neurology or neurodegenerative indications.
• Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations.
• Strong, collaborative team-player.
• Excellent attention to detail and communication skills.

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.

The Opportunity

Reporting to the SVP, Human Resources and Talent Acquisition, the Senior Director, HR Business Partner (HRBP) for the Commercial Organization is a strategic leadership role responsible for partnering closely with the Chief Commercial Officer (CCO) and Commercial Leadership Team to build, scale, and optimize a high-performing commercial function. This individual will serve as a trusted advisor, aligning people strategies with business objectives to support the successful transition to and execution of commercialization, including both corporate and field-based teams.

This role will be hired in advance of commercial scale-up and top-line data, within a lean and evolving organization. While the primary focus is supporting the Commercial function, the Senior Director will initially operate as a broad HR Business Partner across the enterprise, flexing support across Clinical, Technical Operations, and G&A as needed. This role requires comfort operating in a highly dynamic, resource-constrained environment, with the ability to balance strategic leadership with hands-on execution. 

As the organization evolves through key clinical and commercial milestones, this role is expected to scale in scope and impact, transitioning from a broad, hands-on HR Business Partner role to a more dedicated commercial HR leadership position.

Responsibilities

Strategic Partnership & Leadership

• Serve as the primary HR partner to the CCO and Commercial Leadership Team, providing strategic counsel on organizational effectiveness, talent, and culture
• Contribute to the development and execution of the commercial strategy by aligning HR initiatives with business priorities
• Act as a thought partner on scaling the organization from pre-commercial to fully commercial operations

Organizational Design & Build-Out

• Lead the design and implementation of the commercial organizational structure, including headquarters and field-based teams (e.g., sales, market access, patient services, marketing)
• Support workforce planning aligned to launch readiness, market expansion, and long-term growth
• Drive role clarity, spans and layers optimization, and organizational efficiency

Talent Strategy & Development

• Partner with leadership to attract, retain, and develop top commercial talent, including building leadership capability across the organization
• Guide succession planning and leadership development initiatives
• Coach senior leaders on performance management, team effectiveness, and change leadership

Performance & Compensation

• Collaborate with Total Rewards to design and implement competitive compensation and incentive programs aligned with commercial goals (including sales incentives and LTI structures)
• Support performance management processes aligned to corporate and commercial objectives, ensuring the foundational elements of a high-performing commercial culture are in place, including clear goal-setting, accountability, and differentiated performance outcomes

Culture & Employee Experience

• Champion a high-performance, patient-centric culture aligned with company values
• Lead change management initiatives to support rapid growth and evolving business needs
• Ensure strong employee engagement across both corporate and geographically dispersed field teams

Employee Relations & Compliance

• Provide guidance on complex employee relations matters with sound judgment and business alignment
• Ensure compliance with all applicable employment laws and company policies, particularly within a distributed field organization

Required Qualifications

• Bachelor’s degree in Human Resources, Business Administration, or related field required; Master’s degree (MBA, MS, or equivalent) strongly preferred
• Minimum of 15+ years of progressive HR experience, including significant HR Business Partner leadership roles
• Demonstrated experience partnering with a Chief Commercial Officer and senior commercial leadership in building and scaling commercial organizations while being willing to operate beyond a single function and support enterprise-wide needs
• Proven success supporting both corporate and field-based teams, including sales organizations
• Experience within biotechnology or pharmaceutical industry required; rare disease experience strongly preferred
• Comfortable navigating ambiguity and shifting priorities, with a willingness to take on both strategic and hands-on HR responsibilities across multiple functions
• Deep expertise in organizational design, talent management, and change leadership in high-growth environments
• Strong business acumen with the ability to translate strategy into actionable HR initiatives

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis.  Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

The Opportunity

The Senior Director of Patient Services will play a critical role in shaping how Amylyx supports patients throughout their treatment journey. This leader will design, build, and launch a best-in-class patient support program for our lead product candidate, ensuring that it reflects a commitment to supporting patient access, community education, and operational excellence.

This individual will bring strategic vision and hands on leadership to create an integrated support program—from access and reimbursement solutions to patient education and continued on-treatment support. As a key leader in the commercial organization, this individual will partner with colleagues across market access, sales, and marketing, as well as cross functionally, to ensure a seamless and high impact customer experience that helps people start and continue treatment.

This is a unique opportunity to define a foundational capability at Amylyx and set a new standard for patient access support.

Responsibilities

Program Design

• Design a comprehensive, patient‑centered services model tailored to the unique needs of the communities we serve
• Define the strategic framework, service offerings, operational workflows, and end‑to‑end experience for patients, caregivers, and providers, ensuring alignment with the current market access landscape across reimbursement, technology, and delivery models
• Optimize the program by determining the appropriate balance of insourced versus outsourced services and planning for program evolution over time

 Operations Leadership

• Lead end‑to‑end patient support operations, including financial assistance, benefits verification, case management, adherence, nursing, and injection training
• Build, hire, and lead high‑performing internal and field‑based patient access and service operations teams
• Evaluate, contract, and manage third‑party service providers, ensuring strong governance, performance accountability, and alignment with business objectives
• Establish compliant oversight across hub services and all patient‑facing operations in close partnership with Legal, Compliance, and Medical Affairs
• Define KPIs, dashboards, and feedback loops to drive performance, transparency, and continuous improvement across service operations
• Serve as the operational lead for launch readiness and ongoing execution by identifying access barriers, leading cross‑functional issue resolution, and aligning with Commercial, Market Access, Sales, Medical Affairs, IT, and National Accounts teams

Required Qualifications

• Bachelor’s degree required, advanced degree in a related health or business field preferred
• 12+ years of experience in biopharmaceutical patient support services, including product launch and rare disease product access
• Proven track record designing, launching, and managing hub services, reimbursement support, and financial assistance programs
• Expertise in U.S. payer specialty drug coverage, reimbursement mechanics, and specialty pharmacy operations
• Proficiency in analytics and reporting for service programs and pharmacy data
• Knowledge of compliance and regulatory requirements for patient support programs
• Ability to communicate program objectives, launch plans, and performance effectively to internal stakeholders
• Proven people management experience, including hiring, coaching, and developing teams
• Demonstrated leadership of cross‑functional teams in fast‑paced, launch‑focused environments
• An unwavering dedication to patient access and empowering the teams responsible for delivering it

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.

The Opportunity

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)

Required 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.

• 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.

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 training (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.

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.

The Opportunity

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. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.

Responsibilities

• 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

Required 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 Using 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.

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 communicate via video conference, etc.) at your remote locatio

The Opportunity

We are seeking a Senior Director, Market Access Strategy to support a new product launch. This leader will own the creation of the payer value proposition, lead pricing strategy for launch, and prepare effective communications across payer, distribution channel, field access, and patient support teams.

As a key member of the Market Access leadership team, you will work cross functionally to drive strategies for all market access functions, oversee a post-launch marketing and pricing operations team, and effectively manage any vendors that support these initiatives.

Responsibilities

• Shape and lead the payer value story for Amylyx’s first launch product, translating clinical, economic, and real‑world evidence into a differentiated, evidence‑based value proposition that supports optimal access and reimbursement.
• Drive payer marketing and launch execution in close partnership with Medical Affairs, including development of PIE content, AMCP dossiers, and comprehensive launch education materials.
• Partner with Medical and Access leadership to define payer evidence requirements, identify data gaps, and execute strategies to address unmet needs across pre‑ and post‑launch phases.
• Develop and deploy access tools and communications that enable field access teams, patient support programs, and pharmacy partners to execute effectively and consistently.
• Establish a cross‑functional performance feedback loop across payer, field access, pharmacy, and services teams to rapidly identify access barriers and drive issue resolution.
• Build and oversee post‑launch pricing operations, including list price governance, price change management, pricing committee leadership, and close collaboration with Finance on gross‑to‑net management.
• Lead agencies and vendors, monitor payer and policy dynamics, and represent market access strategies including performance, risks, and opportunities—to internal stakeholders and senior leadership.

Required Qualifications

• Bachelor’s degree required
• 12+ years of experience in pharmaceutical market access, pricing, reimbursement strategy, and payer marketing
• Prior launch experience in US market
• Deep expertise in the U.S. payer, reimbursement, coverage, and coding landscape for specialty products under the pharmacy benefit
• Proven experience developing payer value propositions and payer‑facing materials
• Strong analytical skills using market access data sources (e.g., HUB, specialty pharmacy, and claims data)
• People leadership experience, including hiring, coaching, and developing teams
• Demonstrated experience with pricing strategy, contract modeling, and gross‑to‑net management
• Strong vendor management and contracting experience across agencies, consultants, analytics partners, and pricing operations vendors

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.

The Opportunity

Amylyx is looking for a highly experienced Senior Director, Chemistry, Manufacturing, and Controls (CMC), to lead the CMC organization to develop Amylyx’s pipeline including Phase III synthetic peptide, Avexitide, and Phase I antisense oligonucleotide, AMX0114. The CMC group works with external CDMOs to develop robust, scalable, compliant processes for clinical and commercial supply. The Senior Director may lead directly or manage the leads of internal matrix CMC Asset teams and represent CMC on Asset program teams. This leader will work cross-functionally to drive technical excellence and ensure CMC readiness and alignment to program goals.

The ideal candidate will combine strong strategic leadership while working closely with teams and actively contributing to hands-on execution when needed. This role reports to the Senior Vice President, Global CMC and External Manufacturing.

Responsibilities

Strategic Leadership

• Partner with Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing teams to execute CMC strategies for drug development from early-phase through commercialization aligned with asset development plans.
• 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.
• Provide guidance on timelines, budgets, and risk mitigation strategies.
• Evaluate new CDMOs to support tox and clinical material needs. Provide technical leadership for all due diligence and tech transfer projects.
• Travel to global manufacturing sites to support development operations and foster collaboration.

CMC Leadership

• Manage CMC leads and/or lead key matrix CMC Asset teams when needed.
• Author and/or review CMC sections of IND, NDA, and global regulatory submissions (Module 3).
• Ensure compliance with cGMP, ICH guidelines, and FDA CMC requirements.

Process Development & Scale-Up

• Lead phase-appropriate process development, optimization, and validation activities.
• Recommend scientifically rigorous, phase-appropriate, risk management-based solutions to complex technical challenges.
• Develop impurity control strategies and ensure processes meet global regulatory standards.
• Serve as the technical subject matter expert (SME) and process owner when needed.
• Drive successful technology transfers and monitor clinical manufacturing operations, including batch record review and data trending.

Project Management

• Lead and mentor a team of technical professionals, fostering a culture of collaboration, accountability, and continuous improvement.
• Provide career development guidance, performance feedback, and succession planning for team members.
• Allocate resources effectively across projects and ensure alignment with organizational priorities.
• Promote technical excellence through coaching, training, and knowledge-sharing initiatives.
• Drive engagement and retention by creating an inclusive and supportive work environment.

Required Qualifications

• Advanced degree in chemistry, chemical engineering, or related field.
• A solid understanding of small molecule, RNA, and peptide/amino acid chemistries.
• At least 15 years of experience in technical process development from early through late phase. Prior process validation experience preferred.
• Expertise in developing phase-appropriate oligonucleotide and/or synthetic peptide manufacturing processes.
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA, EMA, JP CMC Guidance Documents.
• A strong track record of successful global CMC submissions and approvals.
• Must be able to function independently, influence appropriate stakeholders, and build relationships internally and externally.
• Experience partnering with contract manufacturing organizations.
• Excelling leadership, communication, and collaboration 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 candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

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.

The Position

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.

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.