Beschreibung : Clinical supply manager. Unternehmen : Alentis Therapeutics AG. Lage : Allschwil, BL
Reporting to Senior Project Director
Position Summary The Clinical Supply Manager is accountable for management, coordination and efficient on-time delivery of trial medication (including IMP= Investigational Medicinal Product, Placebo, Standard of Care and clinical ancillaries) supply for global clinical trials to enable the fulfillment of company milestones (FPD=first patient dosed).
The Clinical Supply Manager’s responsibilities include demand forecasting, resupply planning, label design, packaging, distribution, quarantining/recall of IMP in case of issues (with collaboration of QA), destruction, drug reconciliation and active contribution to clinical documents, like the pharmacy manual.
Responsibilities:
IMP and ancillary supply management:
- Plan, implement and execute the strategy for trial medication and ancillary supply in collaboration with clinical and CMC teams
- Manage Standard of Care and ancillary supply purchase activities for clinical trials when supplies are centralized at CMO depot
- Conceptualize packaging design and blinding setup
- Prepare distribution set-up in coordination with clinical team
- Manage trial medication inventory and anticipate re-supply needs in collaboration with CMC team
- Collaborate with external stakeholders, including logistics vendors, to solve issues related to supply
- Act as main contact for labelling and packaging vendors and with clinical sites for topics related to trial supplies
- In case of identified issues with the selected vendor, prepare a request for proposal and lead vendor selection process
Vendor management:
- Manage verbal (regular TC) and written (email) communication with external vendors to ensure project timelines
- Clearly communicate the deadline for various activities / delivery to the vendors
- Supervise outsourced labelling/packaging and distribution operations
- Monitor the performance of the external vendors towards their respective delivery and initiate improvement/mitigation plans as necessary
- Prepare and approve, in accordance with the related SOP, the Master Label Text according to relevant regulation
- Review and approve labelling/packaging records and trial specific document in accordance with the related SOP
- Coordinate IMP and ancillary distribution (manually and/or via the IRT system)
- Monitor drug reconciliation, recall (with collaboration of QA)/quarantine, return and destruction of IMP
- Monitor import/export operations on IMP and ancillary supply until delivery at site
- Report progress and project updates to the line manager on regular basis via email or regular TC
- According to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes
- File and archive trial specific document and GMP records (IMP batch release) and related GCP documents according to internal document management system and Trial Master File
- Draft Pharmacy Manual
- Review and approve external vendor invoices according to project progress status
- In collaboration with GMP / GCP QA and CMC teams, lead the evaluation of deviations which will occur during the storage and/or transfer of the supplies to the clinical sites and archive records as per internal SOP
- In collaboration with CMC team, manage the extension of the expiry dates of IMP according to the ongoing stability studies
- Experience of > 5 years involved in Supply chain/Logistics activities in clinical trials
- Extensive experience in project management and leadership in Clinical Supply Management
- Knowledge and understanding of GMP and GCP regulations as well as other company related regulatory requirements
Work location: Home Based France, contract with Alentis Strasbourg office
Work permit: EC nationality or adequate work permit
About Alentis:
Alentis Therapeutics is developing breakthrough treatments for fibrotic and rare diseases and associated cancers. The company’s lead candidates are monoclonal antibodies that are highly selective for exposed and non-junctional Claudin-1 (CLDN1). Non-junctional CLDN1 is a previously unexploited target with a unique mechanism of action that plays a key role in the pathology of kidney, lung and liver fibrosis, as well as solid tumors.
Alentis` lead therapeutic program, ALE.F02, has finished recruitment into a Ph1a study in healthy volunteers and is currently being developed for the treatment of advanced fibrotic diseases. ALE.C04 will enter clinical studies in oncology in 2023.
Submit your application:
Please submit your application at: [email protected]
