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Clinical Supplies Senior Director is an enthusiastic end-to-end clinical supplies leader that inspires teams while providing expertise in a fast-paced biopharmaceutical clinical supplies environment for Gilead’s global clinical trials. The Senior Director Clinical Supplies works collaboratively with other members of Clinical Supply Chain Management, Pharmaceutical Development and Manufacturing and Clinical Research and Clinical Operations staff to develop strategies, meet project deliverables, solve business problems and create competitive advantage. Gilead continues to expand into new therapeutic areas such as oncology and inflammation in addition to virology to meet unmet medical needs. This role has great exposure to both a diverse portfolio of development programs and a wide-range of therapeutic agents such as small molecules, biologics and cell therapy. This position includes all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
Specific Job Requirements:
- Responsible for managing supplies for dynamic, complex clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3 and Late Phase).
- Leads end –to-end (E2E) clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and approval, and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
- Designs and owns the E2E business processes for clinical supply chain management and ensures the IT system roadmap enables those processes in an integrated manner
- Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
- Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence
- Partner with Regulatory to ensure labels meet global regulatory requirements and supply strategies filed with regulatory bodies support overall developmental strategy and mitigate risk.
- Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement
- Shapes the future of the clinical supply chain management department by participating in recruitment, training, performance management and staff development.
- Provides clear vision and direction to staff while actively mentoring them in their growth and development. Listens to staff concerns and develops action plans to meet long-term objectives.
- Engages the clinical supply chain management team to meet company goals including providing clinical supplies, developing organizational capabilities and continuously improving processes and systems.
- Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
- Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance.
- Supports the budgeting process and reviews purchase orders
- Examines cross-functional issues from a broader organization perspective.
- Can lead departmental strategic initiatives and represent clinical supply management in inter-departmental initiatives.
- Excellent verbal, written, and interpersonal communication skills are required.
- Strong computer and organizational skills required. Project management experiences a plus.
- Must be able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
- Possesses strong 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.
- Must have the ability to write clear, concise and error-free documents.
- Must be able to exercise judgment within defined procedures and policies in order to determine and take appropriate action.
- Must possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.
- Possesses clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export and reverse logistics.
- Works well with ambiguity, can assess options quickly and efficiently and implement best option in alignment with Gilead’s culture and expectations for clinical timelines.
Specific Education and Experience Requirements:
- Requires a Bachelor’s degree and highly preferable in a science-related field; MS, PharmD, or MBA desirable.
- 12+ years of progressively responsible experience in the pharmaceutical industry
- Industry experience in clinical supply management, clinical labeling, formulation development or regulatory roles.
We offer you the opportunity to work within a culture of highly motivated, talented individuals who are dedicated to the company's mission. Each job provides wide-ranging responsibilities due to our cross-functional organizational structure and leadership style, which ensures that everyone is engaged, committed and accountable
We are looking for individuals from diverse backgrounds who want to work together and support each other to help make a real difference in the lives of patients - people who thrive on performing well within a challenging and fast-paced environment, living our core values of Integrity (always doing the right thing), Teamwork (collaborating in good faith), Excellence (working at a high level of commitment and capability), Accountability (taking personal responsibility) and Inclusion (Encouraging Diversity).
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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.