Supply Chain Specialist managing supply chain operations at Itron to improve efficiency and support manufacturing. Coordinates daily activities and collaborates with cross - functional teams for continuous improvement.
About the role
- Senior Manager managing global clinical supply chain for Gilead’s clinical trials. Leading supply management and collaborating cross-functionally to ensure project success in a fast-paced environment.
Responsibilities
- Senior Manager, Global Clinical Supply Chain is a leader that who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials
- Works collaboratively within the department and with cross functional colleagues 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 role may have people leadership accountabilities which include recruiting, onboarding, developing, retaining and managing staff
- The role may have accountability for the strategy, implementation and management of digital tools and systems that support Global Clinical Supply Chain
- 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
- 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 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)
Requirements
- 8+ Years with BS/BA OR 6+ Years with MS/MA or MBA
- Bachelor’s degree with 8+ years of industry experience OR Master’s degree with 6+ years of experience OR PhD or PharmD degree with 2+ years of experience
- Degrees in the sciences preferred
- Strong working knowledge in clinical supply management including and not limited to forecasting, demand / supply planning, IVRS and ERP systems
- Strong working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first in human to late phase
- Strong 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
- Strategic, enterprise thinking with ability to distill complex business problems to technology solutions
- Strong or excellent 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 cross functional resources and timelines for complex clinical study and programs or initiatives/projects
- Project management experience preferred
Benefits
- company-sponsored medical, dental, vision, and life insurance plans*
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
- benefits package
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