Manager, Clinical Supply Chain
Company: Akebia Therapeutics
Location: Somerville
Posted on: June 12, 2022
|
|
Job Description:
---
Supply ChainCambridge, MA ----
ID:
22R-46
--- -Full-Time/RegularNearly 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 disease.This is life-changing
work, and we are all in, are you?The Clinical Supply Chain Manager
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 CSM 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 Manager monitors inventory levels of clinical supplies as
well as key intermediates and manages the processes to maintain
targeted inventory at clinical sites. The manager will assist in
development of supply chain strategies for global clinical trials
including investigational products, placebos and comparators. Will
also lead and develop Master Data Management (MDM) as products
transition from Clinical to Commercial. Will participate in SIOP
process and coordinate with Supply Chain Data Analytics
Team.Required SkillsThe Clinical Supply Chain Manager will: -Be
responsible for the implementation of clinical supply plans, based
on clinical study protocol and clinical development
plans.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 finished product.Ensures
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
development.Review IRT specifications and perform acceptance
testing of IRT when applicable.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.Works 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; negotiates
and communicates supply plan timelines to internal and external
partners.Develop Clinical Supply related SOPs.Provide CMO's and
CRO's appropriate production forecasts and Purchase Orders.Required
ExperienceBasic Qualifications: -Bachelor's degree in Supply Chain,
Business, Engineering, Scientific Discipline, Nursing, or
Pharmacy.5+ years of work experience within a clinical Supply Chain
function in a biotech or pharmaceutical environment.Preferred
Qualifications:Demonstrated track record of creativity and problem
solving within a regulated environmentAbility to exercise
independent judgment with minimal supervisionDemonstrated ability
to work effectively in a global/matrix environmentStrong
organizational and forecasting skills.Proficiency with clinical
supply planning, forecasting, and inventory
reconciliation.Experience with master data management.Experience
with CRO's and Clinical Protocols/Labeling.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, Somerville , Manager, Clinical Supply Chain, Healthcare , Somerville, Massachusetts
Click
here to apply!
|