Executive Director, Global Clinical Supply Chain - Virology
Gilead Sciences, Inc.
2024-09-21 12:37:35
San Mateo,
California,
United States
Job type: fulltime
Job industry: Executive Positions
Job description
Executive Director, Global Clinical Supply Chain - Virology
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly
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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
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Job Description
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Executive Director, Global Clinical Supply Chain (GCSC) - Virology
KEY RESPONSIBILITIES:
Executive Director, Global Clinical Supply Chain is responsible for leading clinical planning function within an assigned therapeutic area (TA). The incumbent is an end-to-end leader who inspires and motivates teams while leading the overall strategy supporting the GCSC function. 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.
The Executive Director 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. This position includes end-to-end elements of clinical planning and execution from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
FOCUS AREA:
- 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.
Basic Qualifications:
- 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.
- 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.
Gilead Core Values