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
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
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
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,
Will work with SOP’s, Change Controls, Deviations, and
Provide CMO’s and CRO’s appropriate production forecasts and
Will be active participant on ERP systems and Supply Chain
Will work to successfully transition products from development
to commercial stage.
Required Experience Bachelor’s degree with 10+ years of work
experience within a clinical Supply Chain function in a biotech or
Proficiency with clinical supply planning and forecasting.
Experience with managing global clinical trials.
Experience with multiple clinical trial programs across multiple
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.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Akebia for any position posted
on our career page must have a current Akebia agency agreement
executed by a member of the Human Resource Department. In addition,
agencies may only submit candidates to positions for which they
have been invited to do so by an Akebia Recruiter. All resumes
submitted outside of these terms will not be considered.