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.

Employment Type : Employee
Experience: years
Vacancy: 1