Senior Director, Supply Chain (Clinical Supplies)

Clinical Supplies Senior Director is an 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 works internally with other members of Global Supply Chain and External Manufacturing and other functions (Development Operations; Clinical Operations; Formulation and Process Development; Device Development and Clinical Package Engineering; Quality Assurance; Regulatory; and Project Management partners), to develop and formulate strategies, meet project deliverables, solve business problems and create competitive advantage. 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.

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Specific Job Requirements:

Manages Supplies

• Leads development of supply strategy and management of supplies for the overall clinical development portfolio, including clinical studies at various phases (Phase 1, 2, 3 and Late Phase).
• CSCM sub team rep for 1 or more developmental programs- typically with complex issues (recent external purchase, new therapeutic area, new delivery methods, etc.).

Works Collaboratively

• Facilitates the development optimal supply strategies and ensure on time delivery of investigational medicinal product (IMP) to initiate and resupply clinical studies (e.g., CSCM Rep in PDM Sub-Team) and resolve shipping relate issues and implement long term solutions/changes
• Drive decision-making at cross-functional teams (Clin Ops, PDM-sub teams) and support the long-term vision.
• Ensures risk balancing by allocating work across partners. Identifies areas where process improvements are imperative and drives cross-company change throughout the organization.
• Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, auditing, onboarding, management, contract negotiation, issue resolution, risk mitigation, and continuous improvements.

GMP Documentation

• Revises, and reviews SOPs, Work Instructions, and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance; influence cross-functional SOP content and review/approve as required

Financials

• Participates in the departmental budgeting process - forecasts labeling and distribution expenses, estimate headcount requirements.
• Review quotes, approves purchase requisitions and invoices as needed
• Drives program allocations decisions and influences and negotiate partner performance.

Management Responsibilities

• Develops vision and direction - Sets priorities and creates clear work plans for organization and individuals; communicates progress regularly; may lead large complex projects within department and represent CSCM in complex cross-functional projects
• Develops Team - Typically oversees a group of mangers and/or professional staff both direct and indirect; recruits, onboards, develops and retains staff while contributing to the development of succession plans
• Drive for Excellence - Sets clear goals and delivers consistently; contributes to setting of department goals; contributes ideas for continuous improvement
• Recognizes gaps in internal procedures to new pending regulation and mobilizes team to develop plans to close gaps. Influences cross functionally to implement industry best practice and identifies opportunities for process improvement

Knowledge:

• 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
• Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.
• Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.
• Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy.
• Expert knowledge of the FDA, cGMP, GCP standards and regulatory guidance documents such as CFR, Annex 13. Able to support regulatory inquiries both F2F and with appropriate responses.
• Expert in leading through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines
• Possesses excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations. Must be a confident communicator and presenter to all organizational levels.
• Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus
• Be able to manage the resources and timelines for multiple teams with studies with different complexities simultaneously. Be able to manage departmental and cross-functional projects.

Specific Education and Experience Requirements:

• 14+ Years with BA/ BS
• 12+ Years with MA/ MS or MBA
• 8+ Years with PHD or PharmD
• Requires a bachelor's degree and highly preferable in a science-related field; MS, PharmD, or MBA desirable.
• Prior experience in complex, oncology trials is highly-preferred.

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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