Clinical Supplies Director
15 hours ago
USDM Life Sciences is seeking a highly experienced Clinical Supplies Director to oversee the supply operations for our client's innovative clinical programs. The ideal candidate will have extensive experience in managing Investigational Medicinal Products (IMPs), drug distribution, and inventory management.
Key Responsibilities:- Manage Interactive Response Technology (IRT) and drug distribution vendors for clinical trials, including packaging, labeling, distribution, return, reconciliation, and destruction activities.
- Develop and maintain the Pharmacy Manual for clinical trial materials (Investigational Medicinal Product, IMP), ensuring IMP is available at sites for dosing of patients during the study.
- Serve as the primary point of contact between various departments and external partners involved in ongoing and new clinical studies, including Tech Ops, QA, Regulatory, Clinical Operations, CROs, and CMOs.
- Oversee clinical supply activities, CMOs, and inventory management, evaluating drug utilization versus forecast considering country requirements and logistical timelines.
- Initiate, oversee, and resolve departmental deviations, collaborating with cross-functional teams to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.
- Extensive experience with clinical trials, particularly in managing IMPs, drug distribution, and inventory management.
- Experience in managing Interactive Response Technology (IRT).
- Strong project management skills, excellent communication and interpersonal skills, and strategic thinking and problem-solving skills.
- Thorough understanding of regulatory requirements and ability to mentor and develop teams.
- Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Supply Chain Management, or a related field.
- Competitive salary and benefits package.
- Opportunity to work with a leading consulting company in the life sciences industry.
- Collaborative and dynamic work environment.
- Professional development and growth opportunities.
USDM Life Sciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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