Jobs at Alkermes

Leads epidemiology strategy supporting discovery, clinical development, safety investigations, regulatory filings, and marketed products. Designs and oversees pharmacoepidemiologic studies, analyzes real-world data, collaborates with HEOR and cross-functional stakeholders, manages vendors and direct reports, and establishes compliant processes, budgets, and capabilities for scaling epidemiology operations.

Serves as the primary contact for patients, healthcare providers, vendors, and insurers seeking access to Alkermes products. Provides reimbursement education, fulfillment coordination, financial assistance assessment, case documentation, and coverage troubleshooting. Partners with internal sales, reimbursement, nursing, and account teams while managing patient transitions across care settings. Maintains compliance, supports program metrics, escalates concerns, and works varied shifts with 15–20% overnight travel.

Leads regulatory review and strategy for pharmaceutical advertising, promotion, product education, and disease-state communications. Advises Marketing, Medical, Legal, Sales, and Regulatory teams on FDA requirements, chairs copy-clearance activities, trains employees, maintains compliance procedures, and serves as the primary OPDP contact for promotional submissions. Requires extensive regulatory advertising and promotion experience, clinical data knowledge, and strong communication and negotiation skills.

Supports R&D IT systems for development, clinical, regulatory, medical, and pharmacovigilance teams in a GxP-regulated pharmaceutical environment. Responsibilities include requirements elicitation, system lifecycle documentation, vendor management, data migration, integrations, issue resolution, solution improvement, and cross-functional delivery. The role ensures FDA computer systems validation, cybersecurity, regulatory, and SOP compliance while supporting Veeva and other R&D platforms.

Leads global pharmacovigilance quality oversight, including risk-based audits, REMS compliance, vendor management, inspection readiness, CAPA remediation, quality systems governance, and continuous improvement. Partners with Drug Safety, Regulatory Affairs, Medical Affairs, Clinical Development, IT, Legal, and external providers to ensure compliance with GVP, FDA regulations, ICH guidance, and organizational quality standards across clinical development and post-marketing activities.

Leads enterprise platform engineering and AI enablement by building secure, scalable AWS platforms, internal developer services, automation, CI/CD standards, infrastructure-as-code practices, monitoring, reliability controls, and governance. Partners with architecture, security, infrastructure, data, and delivery teams to operationalize AI, machine learning, analytics, and generative AI workloads. Advises senior leadership, drives technical initiatives, improves developer productivity, mentors engineers, and supports regulated-industry compliance.

Leads the planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers. Oversees study budgets, timelines, resources, CROs, vendors, compliance, eTMF quality, inspection readiness, risk mitigation, and operational performance. Partners with cross-functional clinical development teams, supports regulatory submissions and inspections, and drives process improvements. Mentors Clinical Operations staff and promotes quality, accountability, and on-time study delivery.

Leads new product planning for pharmaceutical pipeline products by developing market strategies, positioning, product profiles, forecasts, and commercial assessments. Co-leads cross-functional product teams through clinical development, synthesizes market and competitive insights, and prioritizes indications across therapeutic areas. The role requires strong pharmaceutical commercialization, market research, analytical, influencing, and facilitation skills, with occasional travel and a hybrid Waltham, Massachusetts work arrangement.

Leads PMO governance and program management for commercial infrastructure initiatives. Establishes project plans, RAID logs, dependencies, milestones, budgets, dashboards, and executive reporting. Coordinates cross-functional stakeholders across IT, data, commercial operations, finance, and procurement. Supports marketing technology initiatives, acquisitions, organizational transformation, integration planning, roadmap development, and standardized PMO processes.

Manages the pharmaceutical Medical/Legal/Regulatory review process for assigned brands, coordinating submissions, stakeholders, committee meetings, approval queues, final regulatory approvals, records, reports, and audits. Ensures SOP adherence, educates internal and external partners on Veeva Vault processes, supports system improvements and training documentation, tracks metrics, and provides project management support.

Leads enterprise core infrastructure and cloud operations strategy, modernization, reliability, security, and lifecycle management across five global facilities. Oversees compute, virtualization, operating systems, networking, storage, backup, monitoring, patching, resilience, disaster recovery, vendors, budgets, and managed service partners. Manages four direct reports and approximately 50 partner resources while aligning infrastructure roadmaps with business, security, compliance, and operational priorities.

Leads global Marketing and Sales procurement strategy, category management, strategic sourcing, supplier relationships, negotiations, contract management, and value realization. Partners with senior commercial, Finance, Legal, and Compliance stakeholders; manages sourcing events, supplier governance, budgets, reporting, risk mitigation, and continuous improvement. Leads cross-functional initiatives, mentors procurement staff, and supports procurement transformation in a global pharmaceutical organization.

Prepare general ledger journal entries, support month-end close, reconcile accounts and intercompany balances, analyze expenses, process accruals, fulfill external audit requests, and maintain compliance with GAAP, Sarbanes-Oxley, and SEC requirements. The role also supports FP&A, handles accounting special projects, and requires collaboration across internal and external stakeholders in a hybrid office environment.

Lead late-stage small-molecule drug product process development, scale-up and technical transfer (Phase 3 to PPQ). Provide technical oversight at internal and external manufacturing sites, design experiments, develop control strategies, author regulatory process sections, present data to senior management, mentor junior staff, and identify new process technologies.

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.

Provides strategic and operational leadership for clinical data management across pharmaceutical clinical development programs. Oversees study data deliverables, clinical trial databases, data standards, vendor and CRO performance, regulatory compliance, inspection readiness, quality metrics, and database locks. Partners with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Quality Assurance, and external vendors. Leads process improvement, technology implementation, governance, departmental initiatives, hiring, mentoring, performance management, and organizational development.

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 cross-functional program execution for an orexin 2 receptor agonist development program. Translate strategy into integrated plans, manage budgets and timelines, drive governance, mitigate risks, facilitate decision-making, and improve program management tools and processes to ensure delivery across drug development stages.

Lead and manage a security team to design, implement, and improve enterprise DLP and DSPM programs across on‑prem, cloud, and SaaS. Oversee TPRM, enforce policies, coordinate incident response and forensic investigations, perform security architecture reviews, and ensure regulatory compliance (GDPR/CCPA).

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.