Clinical Supply Manager

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis.

Tasks

The Clinical Supply Manager is accountable for management, coordination and efficient on-time delivery of trial supplies (including IMP= Investigational Medicinal Product, Placebo, Standard of Care and clinical ancillaries) for global clinical trials to enable the fulfillment of company milestones.

IMP and ancillary supply management:

• Develop demand forecasts and supply plans based on study protocols, clinical scenarios and enrollment projections.
• Plan, implement and execute the supply strategy for trial medication and ancillary supplies in collaboration with clinical and CMC teams.
• Manage Standard of Care and ancillary supply purchase activities for clinical trials, if applicable.
• Oversee packaging design and lead blinding setup, if applicable.
• Develop and implement global distribution strategies, including depot selection.
• Manage trial medication inventory, expiry dates and anticipate re-supply needs in collaboration with CMC.
• Conduct user acceptance testing (UAT) of IRT/EDC systems and ensure alignment with study requirements.
• Manage IRT systems for supply management and inventory tracking.
• Act as main contact for labelling and packaging vendors and with clinical sites for topics related to trial supplies.
• Review and provide inputs on clinical documentation (e.g. Clinical monitoring plan).
• Prepare a request for proposal and lead vendor selection process, if applicable.

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.
• Coordinate the translations, review and approval of Local Label Texts.
• Review and approve labelling/packaging records and trial specific document in accordance with the related SOP.
• 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.

Documentation management:

• According to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes.
• File and archive trial specific document in Trial Master File.
• Draft and approve Pharmacy Manual.

Quality:

• 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.
• Create, review and update Clinical supply-related SOPs.

Finance:

• Review and approve external vendor invoices.
• Support budget planning and cost control for clinical supply activities.

Requirements

• 3-5 years of experience 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.
• Experience with IRT and EDC systems (e.g. Medidata)Ability to manage multiple studies simultaneously in a fast-paced biotech environment.

Benefits

We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team, please submit your CV.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The work location is Allschwil, Switzerland with 2 days home office possibility.