• Interprets clinical study protocols and/or dosing schema. Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management.
• Performs demand and/or supply forecasting and planning with planning horizon of 9 to 18 months. Translate forecasts into clinical packaging and labeling (CPL) execution plans. Supports contract/quote reviews and purchase order and invoice reconciliations.
• Develops and implements depot and clinical site seeding and resupply strategies.
• Carries out operational/logistics strategies and works with Quality Assurance, and other functional groups to execute strategies that ensure on time and safe delivery of all clinical shipments.
• Collaborate with Logistics management and other members of GCSC, PDM and external partners to resolve shipping related issues. Escalates to senior leadership as needed.
• Supports the clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinical supply strategies and plan with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.
• Ensures accurate inventory and records at depots through timely reconciliation.
• Keeps abreast of clinical supply incidents and issues. Reports and escalates issues as well as investigates root cause as appropriate.
• Performs tasks in Gilead systems (e.g., SAP, IVRS, QMS, etc.) to enable compliant and efficient progression of IMP through the supply chain.
• Authors SOPs and business process work instructions as per leadership direction and support.
• Supports regulatory filings and inspections.
• Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF).
• Keeps abreast of all incidents related to shipment and reports trending to Quality Assurance and assists in creating CAPAs.
• Responsible for maintaining GDP, GMP, and global trade compliance. Maintains compliance to required training.
• Obtain and review quotes, approves purchase requisitions and invoices.

• Bachelor’s degree with 7+ years of industry experience OR Master’s degree with 5+ years of experience OR Ph D or Pharm D degree with 0+ years of experience.

• Degrees in the sciences preferred.
• Strong working knowledge and experience in clinical supply management including and not limited to forecasting, demand / supply planning, distribution strategies, IVRS and ERP systems.
• Working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first in human to late phase.
• Working knowledge of Clinical Demand and Operations Planning (CD&OP).
• Experience with managing comparator drugs and other co-meds for clinical studies.
• Ability to collaborate, influence and negotiate to work effectively with cross-functional teams and external suppliers to meet clinical development timelines and patient needs.
• Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functional expectations.
• Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations.
• Strong computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systems and databases used at Gilead.
• Ability to manage the resources and timelines for complex clinical study and programs. Project management experience is a plus.

The salary range for this position is: $133,280.00 - $172,480.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.