Manager – Clinical Supply Chain

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

📋 Description

• Oversee drug supply operations for one or more clinical trials, which includes planning, label creation, packaging, and distribution.

• Develop and manage supply strategies to ensure a consistent supply for patients while minimizing risks and reducing waste.

• Act as the Clinical Supply Chain representative on Clinical Study Teams and provide support to internal teams such as Clinical Operations, Regulatory, Quality, and CMC.

• Align clinical demand needs, supply strategies, and timelines with Clinical Operations and study teams.

• Formulate supply and inventory strategies and establish production schedules for clinical trial materials.

• Track adherence to production schedules and implement necessary adjustments.

• Oversee GMP inventory management, generate inventory reports, monitor expiration dates, and ensure drug accountability.

• Manage contract manufacturing organizations (CMOs) for labeling and packaging, as well as distribution vendors, supervising their daily operations.

• Investigate discrepancies, identify root causes, implement corrective and preventive actions (CAPAs), and drive resolution.

• Guarantee that label content and proofs adhere to relevant regulations, product specifications, and clinical study protocols.

• Coordinate the review and approval of labels by stakeholders and CMOs.

• Assist with IRT user acceptance testing, develop IRT supply strategies, and oversee ongoing supply system activities.

• Organize and track bulk shipments to CMOs, depots, and vendors while maintaining import licenses.

• Formulate supply strategies, identify potential risks, and create mitigation plans.

• Lead cross-functional drug supply initiatives and improvements in processes.

• Draft and update Standard Operating Procedures.

• Ensure that support staff fulfill their responsibilities for effective study management.

⛳️ Requirements

• Bachelor’s or Master’s Degree in Business Administration, Operations Management, or a related field is required.

• A minimum of 7 years of progressive experience in Clinical Supply Chain, ideally in the biotech, pharmaceutical, or CRO sectors.

• Familiarity with best practices in clinical supply operations.

• Experience with Interactive Response Technology (IRT) systems.

• Background in a cGMP environment.

• Understanding of relevant regulations, product specifications, and clinical study protocols.

• Competence in developing supply and inventory plans and production schedules for clinical trial materials.

• Ability to manage GMP inventory and ensure drug accountability.

• Capability to oversee label and packaging CMOs and distribution vendors.

• Skill in investigating discrepancies, identifying root causes, implementing CAPAs, and ensuring resolution.

• Proficiency in coordinating label reviews and approvals.

• Ability to assist with IRT user acceptance testing and formulate IRT supply strategies.

• Capacity to coordinate and track bulk shipments and maintain import licenses.

• Skills in developing risk mitigation strategies.

• Ability to lead cross-functional projects and drive process improvements.

• Proficient in creating and revising Standard Operating Procedures.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Participation in an incentive compensation plan for commercial roles.

• Access to discretionary equity awards.

• Enrollment in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.