Job DescriptionThe
Global Clinical Supply Chain Manager is a leader who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials. They'll work collaboratively within the department and with cross-functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDMsub-teams, GSC, etc.) to develop strategies, meet project deliverables, and solve business problems.
The position has end-to-end leadership and accountability for clinical supply management. Prioritizes and creates executable work plans to ensure on time in full, safe delivery of investigational medicinal products (IMP). The person will have mature working knowledge of supply chain and experience working with GxP environment, has strong cross-functional, multi-cultural awareness and communication skills in a fast-paced, global company.
Responsibilities:- Interprets clinical study protocols and/or dosing schema.
- Translates the information to IMP demand and supply planning requirements, distributionstrategies 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 andlabeling (CPL) execution plans. Supports contract/quote reviews and purchase order and invoice reconciliations.
- Develop 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 timeand 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 tosenior leadership as needed.
- Supports the clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinicalsupply 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 escalating issues as well as investigate root cause as appropriate.
- Perform 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, approve purchase requisitions and invoices.
Basic Qualifications:- Bachelor's degree with 6+ years of industry experience OR Master's degree with 4+ years of experience OR PhD or PharmD degree with 0+ yearsof experience.
- Degrees in the sciences preferred.
Preferred Qualifications:- 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 developmenttimelines and patient needs.
- Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functionalexpectations.
- Excellent verbal, written, and interpersonal communication skills. Ability to write clearly and concise documents/presentations.
- Strong computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systemsand 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: $123,930.00 - $160,380.00. 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*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
