Clinical Supply Manager

pAlentis 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. /p h2Tasks /h2 pThe 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. /p pstrongIMP and ancillary supply management: /strong /p ul liDevelop demand forecasts and supply plans based on study protocols, clinical scenarios and enrollment projections. /li liPlan, implement and execute the supply strategy for trial medication and ancillary supplies in collaboration with clinical and CMC teams. /li liManage Standard of Care and ancillary supply purchase activities for clinical trials, if applicable. /li liOversee packaging design and lead blinding setup, if applicable. /li liDevelop and implement global distribution strategies, including depot selection. /li liManage trial medication inventory, expiry dates and anticipate re-supply needs in collaboration with CMC. /li liConduct user acceptance testing (UAT) of IRT/EDC systems and ensure alignment with study requirements. /li liManage IRT systems for supply management and inventory tracking. /li liAct as main contact for labelling and packaging vendors and with clinical sites for topics related to trial supplies. /li liReview and provide inputs on clinical documentation (e.g. Clinical monitoring plan). /li liPrepare a request for proposal and lead vendor selection process, if applicable. /li /ul pstrongVendor management: /strong /p ul liManage verbal (regular TC) and written (email) communication with external vendors to ensure project timelines. /li liClearly communicate the deadline for various activities / delivery to the vendors. /li liSupervise outsourced labelling/packaging and distribution operations. /li liMonitor the performance of the external vendors towards their respective delivery and initiate improvement/mitigation plans as necessary. /li liPrepare and approve, in accordance with the related SOP, the Master Label Text according to relevant regulation. /li liCoordinate the translations, review and approval of Local Label Texts. /li liReview and approve labelling/packaging records and trial specific document in accordance with the related SOP. /li liMonitor drug reconciliation, recall (with collaboration of QA), quarantine, return and destruction of IMP. /li liMonitor import/export operations on IMP and ancillary supply until delivery at site. /li liReport progress and project updates to the line manager on regular basis via email or regular TC. /li /ul pstrongDocumentation management: /strong /p ul liAccording to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes. /li liFile and archive trial specific document in Trial Master File. /li liDraft and approve Pharmacy Manual. /li /ul pstrongQuality: /strong /p ul liIn 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. /li liIn collaboration with CMC team, manage the extension of the expiry dates of IMP according to the ongoing stability studies. /li liCreate, review and update Clinical supply-related SOPs. /li /ul pstrongFinance: /strong /p ul liReview and approve external vendor invoices. /li liSupport budget planning and cost control for clinical supply activities. /li /ul h2Requirements /h2 ul li3-5 years of experience in Supply chain/Logistics activities in clinical trials. /li liExtensive experience in project management and leadership in Clinical Supply Management. /li liKnowledge and understanding of GMP and GCP regulations as well as other company related regulatory requirements. /li liExperience with IRT and EDC systems (e.g. Medidata)Ability to manage multiple studies simultaneously in a fast-paced biotech environment. /li /ul h2Benefits /h2 pWe 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. /p pCandidate 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. /pbrpAlentis is the leading biotech company developing anti-Claudin-1 therapies. Claudin-1 is an extraordinary target that plays a key role in many solid tumors and fibrosis. We are committed to unlocking the broad potential of Claudin-1 and bringing much-needed new medicines to patients. /p