Executive Director – Global Clinical Supply Chain – Virology

Executive Director – Global Clinical Supply Chain – Virology

Requirements

• 16+ Years of relevant industry experience with BA/BS. OR 14+ Years with MA/MS or MBA PHD or PharmD.
• Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.
• Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.
• The candidate must demonstrate hands-on end-to-end clinical supply knowledge and experience with clinical trials in therapeutic areas of virology while maintaining elevated, strategic oversight at portfolio level.

Responsibilities

• Responsible for leading clinical planning function within an assigned therapeutic area (TA).
• Provides subject expertise on a diverse portfolio of development programs and different therapeutic modalities including small molecules, biologics and cell gene therapy for Gilead’s global clinical trials.
• Works internally with members in GCSC and other functions including and are not limited to Development Operations, Clinical Operations and Process Development and Manufacturing (PDM) to develop strategies, meet project deliverables, solve business problems and create competitive advantage.
• Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio, including clinical development programs and studies at all phases as well as managed access programs.
• May lead large complex projects within department and represent GCSC in cross-functional projects.
• Leads, develops and manages team, which includes and not limited to recruitment, onboarding, and succession planning.
• Drives excellence and accountable for setting clear goals and consistently delivering. Accountable for setting team goals in alignment with department and enterprise goals.
• Responsible for developing and maintaining a culture of continuous improvement. Mobilizes teams to develop plans, works cross functionally within PDM and at the enterprise level to identify and implement best practices.
• Performs sponsor roles as requested.
• Champions clinical demand and operation planning (CD&OP) interfacing with leaders from Clinical Operations, PDM sub-teams. Manages across enterprise functions and partners to ensure on time in full delivery of investigational medicinal product (IMP).
• Ensures efficient and robust resource allocation for PDM sub-teams and clinical study teams.
• Partners across several PDM functions and with other enterprise functions to ensure the on time in full (OTIF) delivery of IMP to initiate and resupply clinical studies.
• Responsible for decision-making and direct the long-term vision of optimal supply chain strategies including labeling and distribution activities.
• Responsible for risk balancing by allocating work. Identifies and champions areas where process improvements are imperative. Drives resolution of complex issues, through partner sponsors as needed.
• Responsible for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance. Influence cross-functional SOP content and review/approve as required.
• Oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
• Serves as the PDM sub-team for RFD assets, lead supply management for first in human (FIH) clinical trials.
• Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
• Responsible for the departmental budgeting process – forecasts clinical supply spends, estimates headcount requirements as well as department related expenses (contractors, consultants, recruitment, project expenses, etc.).
• Leads TA level allocations decisions and influences and negotiate partner performance.

Preferred Qualifications

• Degree in a science-related field; MS, PharmD, or MBA desirable.
• Strong clinical supply 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.
• Prior experience in complex virology trials is highly-preferred.
• 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 GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face 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.
• 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.
• Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to lead or manage TA, department level and cross-functional projects.