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Clinical Supplies Director

2 months ago

Santa Barbara, California, United States Lifelancer Full time
Job Title: Clinical Supplies Director

USDM Life Sciences is seeking a highly skilled 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, ensuring timely startup of new studies through prompt supply availability.
  • Evaluate 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 potential risks to the progression of clinical programs.
Requirements:
  • 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, with excellent communication and interpersonal skills.
  • Strategic thinking and problem-solving skills, with a thorough understanding of regulatory requirements.
  • Ability to mentor and develop teams.
Education and Certification:
  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Supply Chain Management, or a related field.
Working Conditions:

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

  • Sit or stand at a desk in an environmentally controlled office environment for prolonged periods of time.
  • Constantly operate a computer and other office productivity machinery, such as a calculator, scanner, or printer.
  • Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement:

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.

Disclaimer:

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.