Clinical Supply Chain Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee drug supply operations associated with planning, label creation, packaging, and distribution for clinical trials.

• Formulate and manage supply plans to guarantee precise and ongoing patient supply while minimizing risk and waste.

• Comprehend clinical demand requirements and synchronize study teams with supply plans and timelines.

• Collaborate with internal stakeholders including Clinical Operations, Regulatory, Quality, and CMC departments.

• Act as a liaison with external partners such as CMOs and IRT vendors.

• Define supply strategies, recognize risks, and create risk mitigation plans.

• Develop supply and inventory plans along with production schedules for clinical trial materials.

• Monitor adherence to production schedules and make necessary adjustments.

• Ensure label text and proofs meet applicable rules, regulations, product specifications, and clinical study protocols.

• Assist in developing sourcing strategies and activities for comparators.

• Support IRT user acceptance testing and formulate the IRT supply strategy and DNX parameters.

• Oversee ongoing IRT supply activities.

• Coordinate and monitor bulk shipments to CMOs, depots, and vendors.

• Maintain and oversee import licenses.

• Participate in IRT systems UAT acceptance testing.

• Aid IRT-related activities to ensure sufficient clinical trial supply.

• Undertake additional responsibilities as needed.

⛳️ Requirements

• A Bachelor’s degree or higher in a Medicine/science-related field, supply chain/management/operations, or an equivalent combination of education, training, and experience.

• A minimum of 2 years of progressive experience in Supply Chain, preferably in the biotech, pharmaceutical, or CRO sectors.

• Proficient in Microsoft Word, Excel, and Outlook.

• Strong analytical, communication, and interpersonal skills.

• Excellent organizational abilities and effective time management skills.

• Strong problem-solving and risk management capabilities.

• Good proficiency in Microsoft Office tools.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance coverage.

• Paid Time Off.

• Wellness program.