Jobs at Alkermes

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 design and deployment of enterprise sustainability strategy across sites, translating corporate goals into scalable initiatives. Drive energy efficiency, waste reduction, carbon footprint and LCA assessments, KPI tracking, regulatory compliance, and change management. Coach teams, manage multi-site projects, and embed sustainability into capital projects and operations.

Lead development and execution of lifecycle management strategies and data generation plans (including Phase IIIb/IV and investigator-initiated studies), manage post-approval regulatory activities and sNDA submissions, oversee expanded access programs, build and lead the LCM team, collaborate cross-functionally, manage budgets, and represent the company externally.

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.

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.

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 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 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.

Provide strategic and operational leadership for planning, oversight, and execution of global clinical programs across the development lifecycle, including lifecycle management and sNDA submissions. Manage timelines, budgets, vendors/CROs, study start-up, data integration (IVRS, ePRO, central lab), protocol/SAP development, performance metrics, and direct-report oversight while partnering with cross-functional teams and ensuring regulatory compliance (GCP/ICH).

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 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 establishment and operationalization of R&D data governance across discovery, preclinical, and clinical domains. Define strategy, roadmap, policies, stewardship, metadata, quality, and access controls. Partner with R&D, IT, and Data & AI teams to implement data management platforms, enable FAIR principles, and support self-service data access while ensuring compliance, traceability, and AI-readiness.

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.

Sell Alkermes psychiatric products within the Seacoast territory by building product, disease-state, and market knowledge; target and call on appropriate healthcare providers; develop territory business plans; use approved promotional resources; maintain compliance and accurate administrative and expense reporting; collaborate with field and headquarters teams to grow product use.

Lead and coordinate small-molecule analytical testing to support process development and manufacturing. Supervise day-to-day lab operations, review and approve analytical data and documentation, author/revise SOPs and protocols, oversee equipment qualification and maintenance, troubleshoot methods, manage GMP environmental monitoring, and collaborate cross-functionally to ensure timely, compliant delivery of high-quality analytical results.

Lead analyses to support development, licensing, and M&A by screening products/companies, supporting due diligence, building financial models (forecasting, pro-forma P&L, probability-adjusted NPV), coordinating market research, preparing licensing packages, aiding negotiations and contract review, and communicating corporate strategy cross-functionally.

Lead design and execution of qualitative and quantitative primary market research and competitive intelligence to inform early-stage pipeline decisions. Partner with New Product Planning and cross-functional teams to identify knowledge gaps, manage vendors, integrate data sources, analyze results, and deliver actionable insights for development, commercial, and market access strategies.

Lead development and execution of category strategies for commercial services (market research, sales ops, market access). Manage end-to-end sourcing, supplier relationships, negotiations, contract management, spend analytics, and cross-functional stakeholder partnerships to drive cost optimization, innovation, risk mitigation, and value realization.

Lead global strategic sourcing for Commercial categories, managing RFx, negotiations, contracts, supplier relationships, and cross-functional governance. Drive cost savings, ESG-aligned procurement strategies, process improvements, and manage a team to support regulated pharma operations.