Role Summary
Director, Global Clinical Supply Chain is an end-to-end clinical supply planning leader in a fast-paced biopharmaceutical environment. The role collaborates with Global Supply Chain and cross-functional teams (Clinical Development, Clinical Operations, Product Development & Manufacturing, Quality Assurance, Regulatory, and Project Management Office) to develop supply chain strategies, meet project deliverables and optimize the distribution and inventory of clinical supplies worldwide. The position requires expert knowledge of clinical supply chain best practices, working in a GxP environment, and strong cross-functional, multi-cultural communication to lead in a global company.
Responsibilities
Serves as the clinical supply lead on PDM sub-teams for complex development programs (e.g., late phase, acquisition, partnership/alliance, new modality).
Leads the development and execution of overall clinical supply strategy and management for clinical development programs, including management of investigational medicinal product (IMP) for assigned global trials.
Oversees and supports clinical study planners in a matrix environment; facilitates issue and risk identification, mitigation, resolution and communication.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) to support the long-term vision.
Identifies, manages and mitigates supply risks at the clinical development program level; leads process improvements and organizational changes.
Authors, revises and reviews SOPs, work instructions and business policies.
Accounts for the clinical supply budget of assigned clinical development programs.
Reviews and approves statements of work, purchase orders and invoices.
Influences, and at times drives, program allocations at partners and contract manufacturing organizations (CMOs).
Leads or contributes to GCSC, GSC or PDM strategic initiatives including due diligence resource pools, global drug delivery community, clinical supply integration due to M&A, and policy topic support for EAST.
Qualifications
12+ years of relevant experience with a BS or BA, or 10+ years with an MA/MBA, or 8+ years with a PhD.
Skills
Able to develop complex concepts, techniques, and standards.
Able to develop solutions to complex problems requiring ingenuity, creativity and innovativeness.
Challenges are frequently unique and solutions may serve as precedent for future decisions affecting the 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.
Education
BS or BA (required)
MA or MBA (preferred)
PhD (preferred)
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Responsibilities
Serves as the clinical supply lead on PDM sub-teams for complex development programs (e.g., late phase, acquisition, partnership/alliance, new modality).
Leads the development and execution of overall clinical supply strategy and management for clinical development programs, including management of investigational medicinal product (IMP) for assigned global trials.
Oversees and supports clinical study planners in a matrix environment; facilitates issue and risk identification, mitigation, resolution and communication.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) to support the long-term vision.
Identifies, manages and mitigates supply risks at the clinical development program level; leads process improvements and organizational changes.
Authors, revises and reviews SOPs, work instructions and business policies.
Accounts for the clinical supply budget of assigned clinical development programs.
Reviews and approves statements of work, purchase orders and invoices.
Influences, and at times drives, program allocations at partners and contract manufacturing organizations (CMOs).
Leads or contributes to GCSC, GSC or PDM strategic initiatives including due diligence resource pools, global drug delivery community, clinical supply integration due to M&A, and policy topic support for EAST.
Qualifications
12+ years of relevant experience with a BS or BA, or 10+ years with an MA/MBA, or 8+ years with a PhD.
Skills
Able to develop complex concepts, techniques, and standards.
Able to develop solutions to complex problems requiring ingenuity, creativity and innovativeness.
Challenges are frequently unique and solutions may serve as precedent for future decisions affecting the 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.
Education
BS or BA (required)
MA or MBA (preferred)
PhD (preferred)
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