Senior Clinical Supply Chain Manager
Job Description:
The Sr. Manager position within Clinical Supply Chain leads end-to-end supply chain management on multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as the 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.
Responsibilities
- Proactively lead clinical program supply strategy ensuring trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
- 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 an optimal clinical supply plan
- Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Proactively monitor enrollment activity and inventory levels to ensure demand requirements are met and ensure seamless coordination of demand and supply
- Prepare, update and monitor program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets
- Coordinate US and international distribution and logistics for clinical programs
- Proactively monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
- Lead the 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
- Communicate with external partners on project requirements
- 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
- Collaborate with cross-functional team on regulatory submissions, queries from Health Authorities and participate in Inspections
- Monitor, establish, and manage the creation of SOP's and work instructions that impact the department's day-to-day operations
- Select and apply simulation tools to drive optimal clinical supply plans as appropriate
Qualifications
- Bachelor's degree in a related field and 9+ years' work experience, or a Masters in a Supply Chain or Business-related field and 6+ 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 independently 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
- Travel domestic and international - up to 15%
FAQs
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