At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job DescriptionGilead's Director, Global Clinical Supply Chain is an end-to-end clinical supply planning leader that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain (GSC) and other Gilead functions e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. The individual 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.
ESSENTIAL JOB FUNCTIONS & FOCUS AREA:
Serves as the clinical supply lead on PDM sub-teams especially for complex development programs e.g., late phase, acquisition, partnership/alliance, new modality, etc.).
Leads the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials.
Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Identifies, manages and mitigates supply risks at clinical development program level. Leads and drives visible, impactful process improvements, change business and organizational imperatives.
Authors, revises and reviews standard operating procedures (SOPs), work instructions and business policies.
Accountable for clinical supply budget of assigned clinical development program(s).
Reviews and approves statement of work, purchase orders and invoices.
Influences, at times drives, program allocations at partners, contract manufacturing organizations (CMOs).
Lead or a contributing member to GCSC, GSC or PDM strategic initiatives including and not limited to due diligence resource pool, global drug delivery community, clinical supply integration due to M&A and policy topic member supporting the External Advocacy Steering Team (EAST).
Key Knowledge and Skills
Able to develop complex concepts, techniques, and standards.
Able to develop solutions to complex problems which require an in depth degree of ingenuity, creativity and innovativeness.
Challenges are frequently unique and solutions may serve as precedent for future decisions, which affect the entire organization.
Recommends organizational objectives and interprets company policies.
Establishes organizational policies in a major segment of the company.
Able to interpret, execute, and recommend modifications to department policies.
Demonstrates a comprehensive understanding of the financial aspects of Supply Chain operations.
Specific Job Responsibilities:
Manages the planning, development, implementation, administration and budgeting of the production planning, purchasing, material control, inventory control and shipping/receiving functions.
Provides department management with the coordination of activities and resolution of issues and potential problems related to production planning, procurement, and material management, making or recommending appropriate decisions consistent with strategic direction.
Implements and maintains material control systems, policies, processes and procedures ensuring that a controlled flow of approved materials timed to meet production requirements.
Ensures that personnel, equipment, material and services are provided as needed to maintain acceptable inventory levels.
Coordinates interdepartmental activity with Quality Assurance, Manufacturing, Engineering and Contract Administration.
Provides expertise and guidance in establishment and maintenance of the production control system.
May serve as liaison between the company and the various governmental agencies. Directly interfaces with regulatory agencies as required.
Coordinates interdepartmental activity with Quality Assurance, Manufacturing, Engineering and Contract Administration.
Reviews, approves and/or implements changes to controlled documents as needed.
Develops new applications for the department, based on professional principles and theories.
May negotiate major contracts involving large financial amounts. Monitors cost, schedules and performance aspects of major contracts.
Education & Experience Requirements:
12+ years of relevant experience in related field and a BS or BA; OR
10+ years of relevant experience and a MA/MBA OR
8+ years of relevant experience and a PhD
At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job DescriptionGilead's Director, Global Clinical Supply Chain is an end-to-end clinical supply planning leader that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain (GSC) and other Gilead functions e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. The individual 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.
ESSENTIAL JOB FUNCTIONS & FOCUS AREA:
Serves as the clinical supply lead on PDM sub-teams especially for complex development programs e.g., late phase, acquisition, partnership/alliance, new modality, etc.).
Leads the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials.
Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Identifies, manages and mitigates supply risks at clinical development program level. Leads and drives visible, impactful process improvements, change business and organizational imperatives.
Authors, revises and reviews standard operating procedures (SOPs), work instructions and busines]]>
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