Associate Director, Clinical Supply Chain
Company: Akebia Therapeutics
Posted on: August 6, 2022
Nearly 37 million Americans are currently affected by Chronic
Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come
to work, with the purpose of bettering the lives of each person
impacted by kidney disease and the renal community that serves
them. Our tenacious, passionate employees challenge the status quo
and work to develop unique therapeutics that have the potential to
set new standards of care for people living with kidney
This is life-changing work, and we are all in, are you?
The Clinical Supply Chain Associate Director plans, establishes and
monitors the global clinical supplies strategy for protocol
development, at the study level, to ensure appropriate processes
are established, in order to achieve the clinical supplies key
deliverables for each study, within each program. The CSAD is
accountable for driving the drug supply material planning, at the
study level, for global clinical studies using investigational
product, commercial and comparator material in collaboration with
the global clinical teams. The Clinical Supply Associate Director
monitors inventory levels of clinical supplies as well as key
intermediates and manages the processes to maintain targeted
inventory at clinical sites. The CSAD will assist in development of
supply chain strategies for global clinical trials including
investigational products, placebos and comparators. This role will
also lead and develop Master Data Management (MDM) as products
transition from Clinical to Commercial. The CSAD will participate
in SIOP process and coordinate with Supply Chain Data Analytics
- Be responsible for implementation of clinical supply plans,
based on clinical study protocol and clinical development
- Collaborate with Clinical Trial Managers, clinical packaging
sites, applicable internal functional areas, CROs, and others as
applicable to evaluate and maintain up-to-date status records and
reporting for all clinical supply-related activities across
projects / products.
- Develop and maintain information and reporting, in
collaboration with QA, to ensure transparency of project / product
current expiry periods.
- Collaborate with Clinical Operations, packaging CROs, QA and
regulatory agencies to develop regulatory compliant labels for
- Develop integrated plan to ensure uninterrupted supplies
throughout the duration of a clinical study program.
- Collaborate with Clinical Trial Managers to develop the drug
distribution strategy for each trial and lead the
- Review IRT specifications and perform acceptance testing of IRT
- Work with IRT systems and monitor the site and depot inventory
levels and settings; provide oversight to site and depot shipments;
place manual orders as needed.
- Develop and maintain applicable metrics to monitor performance
relative to clinical trial inventory and planning.
- Collaborate with Clinical Trial Managers and Project Leads to
both gather project / product clinical trial forecast requirements
and demand history data, and generate / revise clinical trial
inventory forecast requirements for planning purposes.
- Work with external consultants and third-party vendors to
ensure timely and quality delivery of CTM that meets study
protocol, regulatory, and budgetary requirements.
- Ensure that key project milestones are met; negotiate and
communicate supply plan timelines to internal and external
- Develop Clinical Supply related SOPs.
- Provide CMO's and CRO's appropriate production forecasts and
- Bachelor's degree in Supply Chain, Business, Engineering,
Scientific Discipline, Nursing, or Pharmacy
- 7+ years of work experience within a clinical Supply Chain
function in a biotech or pharmaceutical environment.
- Demonstrated track record of creativity and problem solving
within a regulated environment
- Ability to exercise independent judgment with minimal
- Demonstrated ability to work effectively in a global/matrix
- Strong organizational and forecasting skills.
- Proficiency with clinical supply planning, forecasting, and
- Experience with master data management.
- Experience with CRO's and Clinical Protocols/Labeling.
- Travel domestically and internationally, as needed.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to
people and ideas. Akebian's aren't afraid of diving in and owning a
process or a problem, because we all want to deliver a great
solution. Akebian's believe that we are better together because we
are all working toward a common purpose - to better the life of
each person impacted by kidney disease. Want to learn more about
what it means to be an Akebian? Visit our website:
COVID 19 Vaccination:All Akebia new hires will be required to
provide documentation that they are fully vaccinated against
COVID-19 or, if not, that they are legally entitled to an
accommodation due to a medical condition or a sincerely held
religious belief. Requests for accommodation will be considered on
a case-by-case basis, and Akebia will consider, among other things
whether a proposed accommodation would create an undue hardship.
Please note that it is unlikely that accommodations can be granted
for customer-facing positions.
Akebia 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.
Keywords: Akebia Therapeutics, Cambridge , Associate Director, Clinical Supply Chain, Executive , Cambridge, Massachusetts
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