Alkermes · 2 days ago
Manager, Clinical Supply Chain
Alkermes is a fully-integrated, global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The Manager position within Clinical Supply Chain leads end-to-end supply chain management for clinical programs, collaborating with various departments to ensure successful drug development and supply activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Review clinical trial protocols and understand impact on supply
Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans
Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts; apply simulation tools to drive optimal clinical supply plan as appropriate
Monitor enrollment activity and inventory levels to ensure demand requirements are met and ensure seamless coordination of demand and supply
Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
Coordinate US and international distribution and logistics for clinical programs
Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
Manage drug returns process and site close-out activities and prepare drug reconciliation reports
Manage label development process
Develop IRT (Interactive Response Technology) User Requirement Specifications and participate in User Acceptance Testing
Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
Communicate with external partners on project requirements
Assist in the creation of SOP’s (Standard Operating Procedure) and work instructions
Update relevant Trial Master Files (TMF) with supply related documents
Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews
Update job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations
Prepare program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets
Qualification
Required
Bachelor's degree in a related field and 10+ years' work experience, or a Masters in a Supply Chain or Business-related field and 7+ years' work experience
APICS certification (CPIM, CRIM, CSCP) is a plus
Proven experience in clinical supplies environment with a strong understanding of clinical study design, execution, and impact of study drug supply from study start-up through trial completion
Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
Demonstrated experience in inventory management (specifically IXRS systems) and forecasting global drug supply requirements
General knowledge of GMP and/or GCP, controlled substance management processes and DEA regulations
Excellent communication and influencing skills, strong collaboration skills and attention to details
Demonstrated ability to prioritize and manage activities in a complex external environment
Proficient knowledge of Microsoft Excel, PowerPoint, demand forecasting, and IRT system experience required
Preferred
Knowledge of Smartsheet, SharePoint, Microsoft Project, and Planview preferred
Lean Six Sigma certification or training preferred
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Recent News
2026-01-03
2025-12-30
Genetic Engineering News
2025-12-24
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