Jobs at Alkermes

Lead delivery of business and IT initiatives using Agile, Waterfall or hybrid methods; define scope, timelines, risks, and governance; own PMO tools, data quality, reporting, dashboards and stage-gate frameworks; drive cross-functional coordination, executive reporting, training, and continuous improvement to ensure on-time, on-budget delivery and portfolio visibility.

Lead market access analytics for LUMRYZ and Rare Disease Sleep Medicine, partnering with commercial teams to deliver dashboards, ad-hoc analyses, KPI tracking, and strategic insights. Manage analysts, implement QC processes, support launch and reimbursement activities, and analyze pharmacy/GPO opportunities using external and internal pharma data sources.

Lead cross-functional commercial analytics supporting brand marketing, field sales, and data teams. Build scalable data infrastructure, automate reporting, develop executive dashboards (Tableau/Power BI), perform HCP/patient and marketing analytics, apply AI-enabled tools to accelerate insights, enforce quality controls, and document data sources, business rules, and processes.

Lead clinical development strategy for Neurology programs across all phases, including protocol design, medical review, study reports, regulatory interactions, and external scientific engagement. Manage and grow the clinical development team, partner cross-functionally on operations, budgets, and due diligence, and serve as an internal and external spokesperson for neurology programs.

Lead global Clinical Quality Assurance strategy and operations (GLP/GCP/GVP), drive inspection readiness, risk-based audit programs, CAPA management, cross-functional collaboration, and build high-performing teams to ensure compliance across clinical trials and regulatory submissions.

Design, maintain, and govern the clinical data ecosystem to support Clinical Operations, Data Management, and Clinical Programming. Lead integrations and data collection from EDC, IxRS, ePRO/eCOA into the Data Lake. Develop data models, governance, and Snowflake-based analytics; support data review, visualization, RBM solutions, and cross-functional issue triage and technical innovation.

Lead clinical design, execution, and oversight of CNS clinical trials. Conduct data review, DSMB support, protocol and endpoint development, literature review, regulatory input, KOL engagement, and contribute to clinical development plans and scientific publications across Phase 1-3 programs.

Lead the Commercial Sleep Medicine PMO for the LUMRYZ program: translate strategy into executable plans, manage governance, risks, timelines, and communications, drive issue resolution, maintain project registers, use Planview and PM tools, and foster continuous improvement across cross-functional stakeholders.

Technical lead for API manufacturing at CMOs, supporting new product introductions, technology transfers, process control and validation, regulatory filings, continuous improvement, and oversight of API commercial production. Manages vendor selection, CMO oversight, cross-functional collaboration, inspections support, and leads a team with ~30% travel.

Lead CRM solution and integration workstreams from design through deployment and stabilization. Define API- and event-driven integration patterns, validate partner deliverables, implement integrations with middleware like MuleSoft, support testing and release activities, tune performance and LDV issues, lead incident triage/root-cause analysis, and maintain operational documentation and runbooks in a regulated life-sciences environment.

Lead program management for ALKS 2680, coordinating cross-functional strategy, timelines, budgets, risk management, and regulatory/registration readiness. Drive integrated program plans, lifecycle management, stakeholder communication, and improvements to program management systems in a hybrid Waltham, MA role.

Lead and conduct GCP/GVP audits of clinical sites, vendors, systems, and documents; oversee external/internal auditors; manage findings, CAPA, metrics, and support regulatory inspections and trainings.

Lead enterprise AI strategy and roadmaps across Commercial, R&D, and Operations. Build AI opportunity portfolio, establish governance, validation, and monitoring processes, drive education and enablement, chair cross-functional review workflows, and grow an AI strategy team to deliver measurable business impact.

Lead and govern end-to-end S/4HANA solution architecture, ensure design integrity, oversee integration (BTP/CPI), validate non-functional readiness, support go-live and hypercare, and define a sustainable post-go-live architecture roadmap.

Lead statistical programming for clinical studies: design and validate SAS programs and CDISC-compliant SDTM/ADaM datasets, produce regulatory TFLs, develop automation tools, provide technical/project leadership, mentor staff, and collaborate with biostatistics, data management, clinical operations, IT and regulatory teams.

Lead and scale enterprise data science capabilities for operations-focused use cases in pharma. Build and deploy production ML/AI and optimization solutions, design reusable ML platforms, engage stakeholders to translate problems into high-impact analytics, and mentor teams while driving adoption and lifecycle management of digital products.

Lead HCP commercialization and launch readiness for Idiopathic Hypersomnia (LUMRYZ), shape HCP segmentation, messaging, digital and promotional materials, partner cross-functionally and with agencies, manage MLR review, and support narcolepsy HCP digital tactics while monitoring and optimizing campaign performance.

Lead statistical programming for clinical studies: design and validate SAS programs and CDISC-compliant datasets, produce regulatory tables/figures/listings, develop automation tools, provide project management and technical leadership, mentor junior programmers, and collaborate with cross-functional teams to ensure compliant, timely deliverables.

Lead a team of biostatisticians supporting Phase I-IV drug development. Provide strategic statistical guidance on study design, analyses, regulatory submissions, vendor/CRO oversight, SOP development, and new methodologies to support clinical development decisions.

Lead clinical pharmacology strategy for CNS development programs, driving dose selection, PK/PD and population modeling, study design and execution, regulatory submissions and agency interactions, and cross‑functional representation. Integrates translational sciences, DMPK data, and quantitative modeling to inform program decisions and external scientific communication.