Sr. Manager/Manager, Clinical Supply Chain

Position Summary :

The Sr. Manager / Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization.

They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions.

In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.

• 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
• Participate in development, review and acceptance testing of IXRS
• Develop IRT 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 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
• 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,
• 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. Knowledge of Smartsheet, SharePoint, Microsoft Project, and Planview preferred
• Lean Six Sigma certification or training preferred

Physical Demands and Work Environment :

Travel domestic and international up to 15%

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.

This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week.

This role is not eligible for fully remote work.

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