Our client's mission is to develop new medicines to treat and cure patients with solid tumors.
We are seeking an innovative, highly motivated, versatile leader to join us as Senior Director of Supply Chain. This role will initially report to the Chief Technical Officer and sit on the Technical Operations Leadership team. The successful candidate will be responsible for developing and implementing a comprehensive Supply Chain Management strategy and business processes that will allow company to scale effectively through clinical development and with a line of sight to commercial. This includes building out the Supply Chain organization, with cross-functional alignment with Clinical, Commercial, and IT teams, to ensure predictable and reliable supply for clinical programs and eventually commercial demand. The scope of this role is broad, covering drug product, viral vector, all supply nodes in the vein-to-vein material flow, raw materials for laboratory, as well as manufacturing, managing relationships with critical suppliers and service providers, building appropriate electronic systems and workflows needed and working cross-functionally with the project teams. This is both a strategic and execution focused role requiring someone to see the big picture, plan, roll up their sleeves and get things done. This is a multidisciplinary role that requires proven leadership to effectively communicate, coordinate, and collaborate cross-functionally with the MSAT, Clinical Operations, External Manufacturing, Quality, CMC Regulatory, Finance, IT, and Commercial teams and product development teams.
Key ResponsibilitiesDefine, execute, and lead the Company's overall Supply Chain strategy to support clinical development of the pipeline programs with a line-of-sight to commercial. Strategies include, but are not limited to: inventory optimization, material planning/management, strategic sourcing, product tracking (chain of identity and chain of custody), cold chain logistics of personalized cell therapies, S&OP, and supporting patient operations and risk management.Establish and execute a clear and accountable phase-appropriate planning process, which includes a robust planning cycle and capabilities to ensure business objectives are met.Improve processes within the end-to-end supply chain, leveraging phase-appropriate tools and solutions, to further drive sustainable improvements and enable future-ready supply chains.Partner with members of the Technical Operations leadership team to ensure the manufacturing and supply chain network is right sized for each stage of development including BLA preparation.Partner with Clinical Operations to support smooth clinical operations at sites, including logistics to ensure company provides positive experience to clinical sites and patients.Negotiate commercial supply agreements with key service providers and suppliers in collaboration with Procurement and External Manufacturing.Manage Regulatory-compliant chain of custody requirements and phase appropriate tools.Collaborate with the Commercial team to define a strategy for digital patient portal to ensure positive patient experience and reliable workflow.Support implementation of the digital portal at the manufacturing sites.Key Requirements15+ years (BA/BS) or 10+ years (Master's degree; MBA preferred) progressive experience in supply chain, inventory management, and materials management roles in biotech/pharma industry.10+ years of related experience including management of the function.Strong analytical and communication skills with business acumen in support of strategic conversations with Executive Leadership team.Represent Technical Operations in multiple cross-functional teams internally when working with Clinical and Commercial. and externally with suppliers and service providers. Act as the senior leader contact for key suppliers.Experience in Supply Chain planning/analytics, material/inventory management, and warehouse & logistics.Experience building digital systems (ERP, SAP, commercial digital portal).Experience building S&OP process with internal stakeholders.Experience in all phases of product life cycle, from preclinical to commercialization.Knowledge of trade compliance, and import/export requirements.Knowledge of technical transfers, qualification, validation, IND, BLA's, FDA inspections, process scale-up, and commercial operations support.Strong supplier management, project management, organizational, and planning skills.Proven negotiation and influencing, and strong interpersonal skills to deliver value.Proven ability to work in a lean organization and creatively solve problems.Ability to build, manage, and develop Supply Chain function.Empathetic leader, who can recruit, retain, and develop talent.Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude.
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