Jobs at Amylyx

Provide CMC quality oversight for sterile and finished drug product manufacturing, packaging, labeling, distribution and related quality systems. Review and approve validation, batch, QC, stability, change control, CAPA, and regulatory submission (NDA CMC) documents. Support inspections and act as QA SME with internal teams and external contract manufacturers to ensure GMP/GDP compliance.

Lead enterprise commercial training and readiness for customer-facing teams. Design scalable curricula across disease, product, engagement, compliance, and launch readiness; manage vendors and cross-functional partners; measure training impact; establish training infrastructure, governance, and continuous improvement to support a 2027 product launch and future growth.

Lead design and execution of a comprehensive healthcare compliance program for a clinical-stage biotech nearing commercialization. Build policies, training, auditing, investigations, third-party due diligence, transparency and FMV processes, board reporting, risk assessments, and compliance operations. Advise commercial and medical teams, drive compliance committee activities, partner on enterprise risk management, and recruit/mentor a high-performing compliance organization.

Partner with Commercial leadership to drive financial planning, forecasting, and performance management for commercialization. Lead annual and long-range planning, build financial models, analyze revenue drivers and pricing, provide executive reporting and recommendations, evaluate strategic investments, and improve FP&A processes to support launch and scale of commercial operations.

The Senior Vice President of Sales will build and lead the commercial strategy for a biotechnology company, overseeing product launch readiness, sales organization development, and engagement with key stakeholders.

Lead national and regional payer engagement to secure evidence-based coverage and patient access for potential product launches. Develop payer strategies, build senior-level payer relationships, support coverage policy and utilization-management recommendations, collaborate cross-functionally on launch readiness, and represent the company at industry forums.

Lead national and regional payer engagement and access strategy to secure coverage for Amylyx therapies. Build senior-level relationships with payers, PBMs, Medicaid, VA/Tricare; support evidence generation, coverage policy, launch readiness, and cross-functional alignment. Drive account plans, presentations, and compliant payer-facing resources.

Serve as Amylyx's primary interface with national and regional payers and PBMs to develop and execute payer strategies supporting coverage and patient access. Lead evidence-based coverage discussions, prepare payer-facing resources, support launch readiness and pre-approval information exchange, analyze policy trends, and collaborate cross-functionally with HEOR, Medical Affairs, Market Access Field Teams, Patient Services, Sales, and Distribution. Travel and territory account management required.

Provide primary onsite and remote IT support, resolve escalations, manage ITIL service operations, administer SharePoint Online, coordinate deployments, support desktop imaging and cloud infrastructure, train staff, and maintain IT operational documentation.

Provide GMP/GDP quality oversight for drug substance, product, and clinical trial materials across manufacturing, testing, packaging, labeling, and distribution. Review and approve quality and regulatory documents (batch records, specifications, IND CMC sections, SOPs, deviations, OOS, CAPAs), prepare batch dispositions, support regulatory inspections, and act as CMC Quality SME with internal teams and external contract manufacturers.

Lead marketing operations for congresses, events, asset lifecycle, vendor and budget management. Ensure compliance with Medical/Legal/Regulatory, manage print/digital production and fulfillment, and drive operational processes, SOPs, and cross-functional coordination to support marketing execution and continuous improvement.

Lead development and execution of integrated media and channel strategies across paid, owned, earned, and emerging digital channels for patient and HCP journeys. Manage media planning, budgets, agencies, measurement frameworks, and cross-functional collaboration to optimize audience engagement and business outcomes while ensuring compliant execution in a regulated life-sciences environment.

Manage procure-to-pay operations including purchase order issuance and closeout, supplier setup and master data, P2P process improvements, reporting, training, and SOX-compliant procurement practices while supporting internal stakeholders.

Provide broad in-house legal and compliance support for a growing biotech preparing for commercial launch. Negotiate and draft contracts, support healthcare and employment compliance, privacy and AI-related matters, manage litigation and outside counsel, lead risk assessments, develop policies and training, and support special projects across Legal and Compliance.

Manage and support G&A business applications with primary focus on NetSuite ERP. Support inventory, purchasing, receiving, fulfillment, and related Finance/Supply Chain processes. Troubleshoot system and transaction issues, create reports/dashboards, maintain documentation, lead change control, testing, and UAT. Partner cross-functionally to improve processes, data quality, controls, and user experience while supporting audits and vendor relationships.

Lead strategy, delivery, and lifecycle management for R&D, clinical, regulatory, safety, and quality systems. Partner with clinical operations, data management and biometrics to implement and integrate CTMS, EDC, eTMF, ePRO/eCOA, IRT, Veeva Vault, and analytics. Ensure GxP compliance (21 CFR Part 11, ICH E6[R3], ALCOA+), drive vendor selection, manage roadmaps and budgets, enable AI use-cases, and support complex decentralized clinical trials with device and wearable integrations.

Lead revenue accounting, gross-to-net operations, and government pricing for a growing biotech. Build scalable processes, controls, and systems; manage outsourced providers; support SEC reporting and SOX compliance; drive pricing and commercial strategy through cross-functional partnership; oversee month/quarter close, audits, and revenue forecasting; hire and mentor a high-performing team.

Lead statistical strategy for clinical development programs from design through regulatory submission. Oversee trial design, analysis plans, CRO/vendor work, regulatory materials, and mentor statisticians. Communicate statistical insights cross-functionally and support regulatory interactions; travel to Cambridge several times yearly.