Manager, Clinical Supplies
Asklepios 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.
The Manager, Clinical Supplies provides strategic oversight of the end-to-end supply chain for assigned gene therapy investigational assets, including provision of placebo supplies, as needed, based on study design and implements supply strategies to deliver investigational medicines to patients. This role is responsible for influencing clinical plans relative to investigational product (IP) supply and optimizing supply strategies, so they are patient-focused, risk-adjusted, and cost effective. Furthermore, the CSM follows through on supply chain performance to ensure successful execution of the supply chain, with a focus on quality. This role involves oversight of AskBio sponsored clinical studies (all phases).
We are excited about our next Manager, Clinical Supplies to join the AskBio team!
The Manager, Clinical Supplies will:
- Lead the cross-functional Clinical Supply Chain team and is accountable for the Clinical Supply Workstream as part of the overarching development process.
- 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 supply.
- 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 budget allocation.
- Ensure supply chain planning is aligned with key project milestones
- 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 or cost.
Required Education & Experience
- Relevant experience working in a highly regulated, technical industry (e.g. pharma, vaccines or consumer healthcare).
- Degree (or equivalent) 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 Education & Experience
- APICS or CILT certification.
- Training/experience in Lean Sigma and Project Management.
- Clinical Trial Supply Chain domain experience and knowledge.
- Strong knowledge of cGxP requirements.