Manager, Clinical Supplies
Company: Asklepios BioPharmaceutical, Inc. (AskBio)
Posted on: January 16, 2022
About AskBioAsklepios BioPharmaceutical, Inc. (AskBio), a wholly
owned and independently operated subsidiary of Bayer AG acquired in
2020, is a fully integrated AAV gene therapy company dedicated to
developing life-saving medicines that have the potential to cure
genetic diseases. The company maintains a portfolio of clinical
programs across a range of neuromuscular, central nervous system,
cardiovascular and metabolic disease indications with a
clinical-stage pipeline that includes therapeutics for Pompe
disease, Parkinson's disease, and congestive heart failure, as well
as out-licensed clinical indications for hemophilia and Duchenne
muscular dystrophy. AskBio's gene therapy platform includes
Pro10---, an industry-leading proprietary cell line manufacturing
process, and an extensive AAV capsid and promoter library. With
global headquarters in Research Triangle Park, North Carolina, and
European headquarters in Edinburgh, UK, the company has generated
hundreds of proprietary third generation AAV capsids and promoters,
several of which have entered clinical testing. Founded in 2001 and
an early innovator in the gene therapy field, the company holds
more than 850 patents in areas such as AAV production and chimeric
and self-complementary capsids. Learn more at www.askbio.com
We have an opportunity for a Manager, Clinical Supplies to join
AskBio's team and be part of our continued success!
Position OverviewThe Manager, Clinical Supplies will provide
oversight of the supply chain for assigned gene therapy
investigational assets, including the provision of placebo supplies
and implements supply strategies to deliver investigational
medicines to patients.
- Lead the cross-functional Clinical Supply Chain team and is
accountable for the Clinical Supply Workstream as part of the
overarching development process.
- Influence clinical plans relative to investigational product
(IP) supply and optimizing supply strategies.
- Build and maintain strong working relationships with Clinical
and cross-functional program teams, including serving as the first
point of escalation for issues related to clinical product
- Challenge key assumptions and Clinical planning parameters
while influencing clinical study proposals to ensure efficient
cost/risk/ benefit trade-offs.
- Contribute to study specific Pharmacy Manuals as necessary to
support study start and execution.
- Develop and supervises long-term demand and supply plans for
all assigned AskBio assets.
- Design and executes supply chain strategies that ensure
consistent timely delivery of IP with minimal waste.
- Work with business partners to oversee the effective execution
of supply chain plans while proactively identifying potential
obstacles to success and taking action to resolve issues.
- Develop costed, risk-based scenarios for supplies to enable the
Clinical Development Team(s) to make informed decisions regarding
- Ensure supply chain planning is aligned with key project
- Create, lead, influence, and work with cross-functional teams,
including third-party groups, to co-ordinate and handle the
delivery of clinical supplies for specified AskBio asset(s).
- Creates Study Specific Clinical Supply Plans (or equivalent)
for specified projects.
- Accountable for problem-solving and resolution of issues
involving a range of technical, quality, regulatory and operational
issues to ensure delivery to patient without compromising quality
Required Education & Experience
- Experience working in a highly regulated, technical industry
(e.g. pharma, vaccines or consumer healthcare).
- Degree in Pharmacy, Chemistry, Logistics or related scientific
or technical discipline.
- Experience in the management of clinical trial supplies
including, but not limited to planning, forecasting, inventory
management, clinical packaging, distribution, and IRT.
Preferred Experience and Skills
- APICS or CILT certification.
- Training/experience in Lean Sigma and Project Management.
- Clinical Trial Supply Chain domain experience and
- Strong knowledge of cGxP requirements.
Keywords: Asklepios BioPharmaceutical, Inc. (AskBio), Durham , Manager, Clinical Supplies, Executive , Durham, North Carolina
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