The Director, Head of Clinical Supply Chain will lead the global Clinical Supply Chain to ensure uninterrupted product supply. The Director will be responsible for Planning, Forecasting, and Inventory Management; coordination with internal partners in Clinical Operations, External Manufacturing, Finance, Quality, Development, Regulatory, and Purchasing. Will lead all clinical supply chain related activities including new studies, new product introductions, and ensuring production schedule adherence. Will lead and develop Clinical Supply Chain Team while enhancing capabilities. Will participate in SIOP process and coordinate with Supply Chain Data Analytics Team.
Required Skills
- Technical proficiency in clinical supply chain technologies and processes.
- Assure fulfillment of all supply milestones across all Akebia development programs, including all clinical trials. Activities include demand forecasting, trial monitoring, resupply planning, label design, packaging, and IRT set-up and distribution. Scope will include investigational drug, comparator drugs, placebos, and ancillary supplies as applicable.
- Demonstrated experience in building-out a clinical product supply chain.
- Translating Clinical and Development demand to a rolling supply forecast and firm production orders to sustain supply, in conjunction with CMO’s and CRO’s within a cGMP-regulated environment.
- Manage end to end clinical supply planning process including but not limited to shelf life extension, bulk drug product manufacturing, scenario planning and inventory movement.
- Develop integrated plans to ensure uninterrupted supply of material, such as regulatory starting materials, bulk drug substance and drug product, and finished goods for clinical demand.
- Ensure that key project milestones are met; negotiates and communicates supply plan timelines within Pharmaceutical Operations and with internal and external partners.
- Responsible for schedule adherence, product specific dashboard, financial metrics/budgeting.
- Will work with SOP’s, Change Controls, Deviations, and CAPA’s.
- Provide CMO’s and CRO’s appropriate production forecasts and Purchase Orders.
- Will be active participant on ERP systems and Supply Chain transactions.
- Will work to successfully transition products from development to commercial stage.
Required Experience
- Bachelor’s degree with 10 years of professional work experience with at least 5 years in clinical Supply Chain function in a biotech or pharmaceutical environment.
- Proficiency with clinical supply planning and forecasting.
- Experience with managing global clinical trials.
- Experience with multiple clinical trial programs across multiple product lines.
- Experience with CRO’s and Clinical Protocols/Labeling.
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.
Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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