Amylyx Pharmaceuticals

Vice President

• Provide a strategic leadership role in the Biometrics Team and cross-departmental program team to ensure the biometrics scopes and timelines defined to meet the corporate objectives
• Lead and manage the biostatistics team and provide statistical strategies to drug development including development plans, innovative or adaptive study designs, and cross-study analyses including basic and complex statistical methodology implementation, data interpretations, regulatory submissions
• Act at the lead presenter of statistical data and results of clinical trials to senior management, regulatory agencies, or individual investigators
• Oversee execution of statistical tasks, resources, timelines and budgets for the function
• Provide guidance and support to develop individual protocols and data analysis plans and determine appropriate statistical methodologies for analysis; analyze data and interpret results from clinical trials to meet objectives of the study protocol
• Mentor biostatisticians and oversee execution of major statistics deliverables and milestones in collaboration with other functions
• Build and maintain a partnership with CROs or individual consultants as needed, provide statistical oversight to tasks outsourced and assure adequate quality and consistency with company and industry standards
• Participate and collaborate in database design meetings as needed to ensure high quality data evaluated and analysis requirements satisfied
• Review and approve responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
• Review and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies
• Ensure compliance with GCP and other regulatory requirements

Vice President, Biostatistics

Director

• Lead CMC drug substance phase appropriate process development activities from Phase 1 through NDA ensuring Module 3 content supports global clinical filings and registration plans
• Serve as the technical SME and process owner for drug substance. Working with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products
• Evaluate new CDMOs to support tox and clinical material needs. Serve as the technical SME on all DS tech transfer projects
• Monitor drug substance GMP operations including clinical batch record review, and process data trending and support of related quality events.
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Understand regulatory plans for all proposed changes, minimizing risk to product supply
• Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams.
• Provide input to project timelines and budgets and communicate progress
• Regularly interacts with key CMC team members including Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing
• Travel to global manufacturing sites to support operations and validation activities

Associate Director, Drug Substance

• Develop and execute the national field medical strategy in alignment with the broader Medical Affairs and company objectives. Define the vision, set strategic goals, design and report KPIs, and ensure tactical execution across the field team.
• Recruit, hire, train, and manage a high-performing field medical team. Foster a culture of scientific excellence, accountability, and continuous learning. Provide mentorship, coaching, and career development opportunities to team members.
• Oversee the team's scientific exchange activities with external stakeholders, including national and regional KOLs, healthcare providers (HCPs), and professional medical societies. Ensure the team delivers timely, impactful data and communicates scientific information accurately and compliantly.
• Partner closely with internal departments—including Medical Affairs, Commercial, Clinical Development, R&D, Market Access, and Regulatory—to ensure alignment and support for product launches, payer engagements, clinical trial activities, and other strategic initiatives.
• Establish a process for gathering, summarizing, and disseminating field-based medical insights to internal stakeholders to inform strategic decision-making and identify educational gaps.
• Ensure all field medical activities adhere to company Standard Operating Procedures (SOPs) and regulatory and compliance guidelines. Oversee operational aspects, including budget management, performance tracking, and the effective use of customer relationship management (CRM) systems.

Senior Director, Field Medical Affairs

Medical Director

• Lead late-stage, pivotal clinical development program and potentially additional programs for the same molecule
• Provide medical monitoring for assigned clinical trials in serious endocrine conditions, neurodegenerative and/or rare disease
• Develop and implement Clinical Development Plan including clinical study design, execution, and interpretation of study data
• Interact within a multi-disciplinary, matrix work group including research, pharmacology, drug discovery, regulatory, operations, statistics, CROs, and external experts
• Participate in translational activities, operationalize studies, and monitor data in real time to ensure study integrity
• Proactively identify issues in trial conduct and perform medical review and analysis of data for data cleaning, regulatory documents, and publications
• Produce high-quality program documents including protocols, Investigator Brochures (IBs), clinical study reports, briefing documents, and drug labels
• Develop and maintain relationships with internal stakeholders, global medical expert community, regulatory authorities, alliance partners, and vendors
• Lead a small team of clinical scientists and physicians and report to the Senior VP of Clinical Development
• Contribute to business development activities and organizational initiatives in Clinical Development

Senior Medical Director, Clinical Development

Translator

• Lead design, development, and implementation of bioanalytical assays (LCMS, ELISA, qPCR, immunogenicity, cell-based biomarker, in vitro biomarker, etc.) to advance preclinical and clinical programs
• Serve as bioanalytical subject matter expert supporting outsourced bioanalytical strategy, operations, and vendor management
• Contribute to multiple drug programs and serve on cross-functional preclinical and clinical drug program teams
• Select and manage vendors, oversee outsourced bioanalytical and biomarker methods, and ensure methods are developed and qualified/validated following FDA and ICH guidelines
• Review and lead bioanalytical MD/MV reports and data summaries and collaborate with nonclinical toxicologists, clinical pharmacologists, and biostatisticians
• Drive PK, PD, and immunogenicity testing strategy and ensure vendor qualification/validation work meets timelines and quality standards
• Participate in planning, reviewing and authoring regulatory and clinical documents, abstracts, posters, protocols, and publications
• Identify and resolve root causes of bioanalytical method issues and manage critical reagent life-cycle
• Prepare and organize data for cross-functional presentation and communicate results to management, collaborators, and at scientific meetings
• Provide bioanalytical expertise for diligence on external assets and potential in-licensing opportunities
• Occasional travel required for collaboration, conferences and vendor oversight/audit; travel to Cambridge, MA office at least 3 times annually

Director, Bioanalytical and Translational Science

• Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders.
• Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges.
• Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance.
• Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences.
• Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success.
• Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually.
• Liaise with internal and external stakeholders (e.g. Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions and post-submission strategies/preparation/defense.

Director, Biostatistics

• Lead CMC drug substance phase-appropriate development activities to ensure Module 3 content that supports global clinical filings and registration plans
• Serve as the technical SME and process owner for drug substance; develop scalable and robust manufacturing processes for oligonucleotides and peptide products with CDMOs
• Author IND and NDA Module 3 content, Master Batch Records, Validation Plans and Reports
• Ensure robust regulatory plans for changes while minimizing risk to product supply
• Foster effective teamwork and drive project execution; track critical path activities, anticipate risks, create contingency plans, update timelines and budgets, and maintain the CMC program plan
• Regularly interact with Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development
• Manage external resources including consultants and contractors as needed
• Travel to global manufacturing sites to support operations and validation activities

Director, Drug Substance

• Build strong partnerships across business and technical teams to foster collaboration and effective project execution.
• Lead the implementation and support of Commercial and Medical business-facing applications, ensuring alignment with strategic priorities.
• Serve as the primary IT contact for audit and compliance matters related to Commercial and Medical systems, ensuring adherence to regulatory and internal controls.
• Establish and maintain IT processes and standards for application support within the Commercial and Medical domains.
• Oversee application enhancements and support activities in alignment with product launch and business objectives.
• Act as a functional and technical advisor to define, estimate, and propose solutions for business opportunities.
• Contribute to annual budgeting and planning for Commercial and Medical systems.
• Administer CRM platforms (e.g., Salesforce, Veeva) for Commercial and Medical Affairs teams.
• Manage vendor relationships, including assessments and contract negotiations.
• Coordinate issue resolution with internal teams and external service providers.
• Maintain the integration roadmap for Commercial and Medical applications (e.g., Commercial Data Environment, HUB, Aggregate Spend, Master Data Management).
• Lead RFP processes, evaluate proposals, develop ROI analyses, and ensure proper documentation for IT initiatives.
• Ensure compliance with regulatory requirements, including FDA computer systems assurance, SOX, and GDPR.

Director, IT Commercial Applications

• Report to the SVP of Medical Affairs and lead the HEOR function
• Build and lead the HEOR function including the development of integrated HEOR and evidence generation strategies and tactical plans to support Amylyxs therapeutic programs
• Lead evidence gap analyses to inform HEOR strategic and tactical plans and lead cross-functional data generation and communication planning efforts
• Design and execute projects such as burden of illness, real-world clinical outcomes, clinical registries, retrospective database analyses, and meta-analyses
• Provide scientific support for protocol development, target product profiles, data collection strategies, literature review and evidence synthesis
• Oversee stakeholder engagement and communication, including peer-reviewed publications, conference presentations, and internal communication of HEOR findings
• Support global market access strategy including early scientific advice with HTA agencies, regulatory support, and preparing for global HTA models
• Ensure HEOR tactics are aligned cross-functionally with business strategies and regulatory guidelines and monitor and interpret U.S. policy changes
• Collaborate with Market Access and Medical Affairs to develop and maintain evidence packages tailored to U.S. payers (commercial, Medicare, Medicaid)
• Lead vendor selection and manage external research partners; build and manage a team for real-world evidence generation and health economics research
• Manage HEOR budget planning and resource allocation to ensure efficient execution of strategic priorities

Senior Director, Health Economics and Outcomes Research / Real-World Evidence

• Lead the development and execution of strategies to engage patient communities and professional organizations.
• Ensure the patient voice is integrated across the product lifecycle
• Refine and implement a comprehensive patient and professional advocacy strategy aligned with corporate goals.
• Serve as the internal champion for patient-centricity and incorporating patient insights into decision-making across functions including Clinical Development, Clinical Operations, Medical Affairs, Commercial, Regulatory, and Communications.
• Build and maintain trusted relationships with patient advocacy organizations. Serve as the primary liaison between the company and external advocacy stakeholders.
• Lead initiatives to incorporate patient insights into clinical trial design, access strategies, communications, and educational programs.
• Represent the company at patient-focused events, advisory board meetings, and conferences.
• Build and maintain strategic relationships with medical societies and professional organizations to support disease awareness, scientific exchange, and shared advocacy initiatives.
• Partner with internal stakeholders to align advocacy efforts with scientific and medical strategies.
• Work closely with Clinical Development, Market Access, Corporate Communications, Regulatory, and Legal/Compliance to ensure integrated and compliant engagement.
• Support internal training and awareness to deepen employee understanding of the patient experience and to educate on patient advocacy best practices.
• Ensure all advocacy activities comply with regulatory, legal, and ethical standards.
• Manage sponsorships, grants, and partnerships in alignment with company policies.

Senior Director, Patient and Professional Advocacy

Pricing Analyst

• Lead commercial analytics efforts across PBH and pipeline products, supporting strategic planning and operational execution
• Independently analyze and interpret healthcare datasets (e.g., claims, specialty pharmacy, EMR) using SQL, Excel, and other tools to uncover insights on patient journeys, provider behavior, and market dynamics
• Develop and maintain dashboards and reports that support commercial performance tracking and forecasting
• Translate complex data findings into clear, compelling presentations for cross-functional stakeholders and senior leadership
• Partner with Marketing, Medical Affairs, Market Access, and Supply Chain to align analytics with business needs and strategic priorities
• Support launch readiness and post-launch performance tracking for new products and indications
• Identify opportunities for data acquisition and infrastructure improvements to enhance analytics capabilities
• Collaborate with external vendors and data providers to ensure quality and relevance of third-party data sources
• Stay current on industry trends, competitive intelligence, and emerging data methodologies to continuously elevate the analytics function