Job Responsibilities:
- Interpret clinical study protocols and/or dosing schema; translate into IMP demand/supply planning requirements and distribution strategies, including depot inventory management.
- Perform demand and/or supply forecasting and planning (9โ18 month horizon); translate forecasts into clinical packaging and labeling (CPL) execution plans; support contract/quote reviews and purchase order/invoice reconciliations.
- Develop and implement depot and clinical site seeding and resupply strategies.
- Execute operational/logistics strategies with Quality Assurance and other functional groups to ensure on-time, safe delivery of all clinical shipments.
- Collaborate with Logistics management, GCSC, PDM, and external partners to resolve shipping issues; escalate to senior leadership as needed.
- Support clinical development and PDM strategies to develop clinical supply strategies and plans focused on delivering compliant, quality IMP globally on time in full.
- Ensure accurate depot inventory and records through timely reconciliation.
- Monitor clinical supply incidents/issues; report/escalate and investigate root cause as appropriate.
- Use Gilead systems (e.g., SAP, IVRS, QMS) to enable compliant IMP progression through the supply chain.
- Author SOPs and business process work instructions as directed.
- Support regulatory filings and inspections; maintain compliance of clinical supply deliverables for CSR and TMF.
- Assist with CAPAs; maintain GDP/GMP/global trade compliance and required training.
- Obtain/review quotes; approve purchase requisitions and invoices.
Basic Qualifications:
- Bachelorโs degree + 6+ years industry experience OR Masterโs degree + 4+ years OR PhD/PharmD + 0+ years.
- Sciences degree preferred.
Preferred Qualifications:
- Strong clinical supply management experience (forecasting, demand/supply planning, distribution strategies, IVRS, ERP).
- Clinical study design and blinding practices; global trials (Phase 1 first-in-human to late phase).
- Knowledge of Clinical Demand and Operations Planning (CD&OP).
- Experience managing comparator drugs and other co-meds.
- Ability to collaborate/influence/negotiate with cross-functional teams and external suppliers.
- Works effectively with ambiguity; strong communication skills.
- Strong computer skills and ability to adopt systems/databases.
- Ability to manage resources/timelines for complex studies/programs; project management a plus.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.