Onsite- 3 days per week (San Mateo, CA or Carlsbad, ca)
MUST HAVE- Clinical supply phase 1-3 experience
Responsibilities include:
Supports end-to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation, and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
- Carries out operational/logistics strategies and works with CSCM, Quality Assurance, and other functional groups to execute strategies that ensure on-time & safe delivery of all clinical shipments
- Ensures accurate inventory records at all depots through timely reconciliation
- 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
- Collaborate with Logistics management and other members of CSCM, PDM, and external partners to resolve shipping related issues; Escalates to senior leadership as needed
- Revise and author SOPs and Work instructions with manager direction and support
- Obtain and review quotes, approves purchase requisitions and invoices.
Management Responsibilities:
- Implement business strategies in-line with the vision and goals set forth by the department Ensures priorities are being met and creates clear work plans for staff; communicates progress regularly.
- Typically recruits, onboards, develops, retains, and supervises staff; sets clear goals for individuals.
Knowledge and Skills:
- Possess strong clinical supplies management experience/ knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations.
- Possesses collaboration, influencing, and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Possesses experience with clinical blinding practices in global studies, from Phase 1 to Late Phase.
- Possesses solid experience in sourcing and managing comparator drugs and other co-meds for clinical studies.
- Mature knowledge of the FDA, cGMP, GCP standards and regulatory guidance documents.
- Works well with ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines.
- Excellent verbal, written, and interpersonal communication skills are required. Must have the ability to write clear, concise, and error-free documents/presentations.
- Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.
- Able to manage the resources and timelines for programs of moderate complexity.
Education and Experience:
ยท 7+ years of relevant experience and a Bachelor's degree
ยท 5+ years of relevant experience and a Master's degree
ยท 0+ years with PHD or PharmD (entry level)
- ยท Degrees in the sciences preferred
