Clinical Trial Supply Manager
vor 3 Wochen
Intro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ. Location: Berlin, Germany; office based, 75-100 % negotiable, or remote with 10 % presence in the Berlin office Summary: Our lead candidate, the LAG-3 based recombinant protein eftilagimod alfa, is currently undergoing pivotal clinical trials in cancer on a global scale. You will work closely with the Senior Director of Manufacturing to define and execute an optimal clinical trial supply strategy for Immutep’s clinical study pipeline, ensuring supply continuity to patients. Your responsibilities include establishing and managing the depot network and distribution to clinical sites, determining label and kit design, forecasting the demand for the investigational product and ancillary supplies, ensuring on-time supply of study medication and ancillary materials to clinical sites, and overseeing the final return and destruction process. Tasks Generates study specific Request for Proposals (RFP) based on study assumptions, decision-making to final vendor selection as well as contract negotiation (Master Service Agreements, Work Orders and Change Orders). Establishes and monitors global network of regional and global depots to distribute investigational product, comparators and ancillary supplies to countries and study sites in assigned clinical trials. Coordinates timely and compliant importation and supply of investigational product, comparators and ancillary supplies into regional and global depots. Manages the inventory levels and product expiry. Develops and maintains complete and accurate clinical supply demand forecast for the assigned study in alignment with protocol requirements, key study parameters, and patient projections, with appropriate overage. Determines labelling and clinical kit design and a comprehensive label strategy for all participating countries in the clinical trial. Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity. Generates optimal distribution plans for investigational products, jointly with partner or vendor. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots. Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies. Manages and provides support in establishing of IWRS or IRT system of blinded and open label trials. Creates and updates budgets for studies including packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs for assigned clinical studies. Strives for cost optimization and manages KPIs for the assigned procurement categories. Closes collaboration with the Manufacturing team as well as Clinical Operations, Quality Assurance and enabling functions such as Legal and Finance. Participates in management reviews of process performance, product quality and the quality management system. Provides requested input on forecast of annual budgets. Provides requested input to Product Development Plans and Portfolio Review. Represents the Company at external conferences and meetings. Requirements Essential: Post graduate degree in natural / life sciences / engineering background. At least 5 years of practical experience in pharmaceutical industry or >3 years’ experience in supply chain management. Experience in clinical trial supplies leading global studies preferably with biologics. Strong project management skills paired with good communication skills in cross functional project teams. English Language skills. Good working knowledge of using Microsoft office programs. Desirable Experience in vendor selection/management. Profound knowledge in pharmaceutical procurement, specifically Clinical Trial Supply Services such as CMOs and CROs. Good negotiation skills. Strong understanding on the Drug Development process. Previous experience in supervising, mentoring or training colleagues and setting objectives is an advantage. Knowledge of relevant regulations and guidelines (GMP, GDP, GCP). Closing Job expectations: Multifunctional interesting tasks in the emerging field of immune therapeutics. Be part of the development of a "first in class” drug. Highly motivated and energetic international team. Competitive compensation. Expected start date: 1st Jan 2025
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Clinical Trial Supply Chain Manager
vor 2 Wochen
Berlin, Deutschland Immutep Karriere VollzeitJob OverviewWe are seeking a highly skilled and experienced Clinical Trial Supply Chain Manager to join our team at Immutep Karriere in Berlin, Germany.About the RoleThe ideal candidate will have a strong background in clinical trial supplies and experience in managing global studies with biologics. The successful candidate will be responsible for defining...
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Clinical Trial Supply Chain Manager
vor 2 Wochen
Berlin, Berlin, Deutschland Immutep VollzeitRole OverviewWe are seeking a skilled Clinical Trial Supply Chain Manager to join our team at Immutep, an emerging international biotechnology company developing innovative treatments for cancer and autoimmune diseases.The successful candidate will play a crucial role in defining and executing an optimal clinical trial supply strategy, ensuring the...
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Clinical Procurement Manager
vor 2 Wochen
Berlin, Berlin, Deutschland Immutep VollzeitJob Summary:We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. Our lead candidate, the LAG-3 based recombinant protein eftilagimod alfa, is currently undergoing pivotal clinical trials on a global scale.Key Responsibilities:Work closely with the Senior Director of...
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitIntroCompany:We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 2 Wochen
Berlin, Deutschland Immutep VollzeitIntro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ....
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Clinical Trial Supply Manager
vor 2 Wochen
Berlin, Deutschland Immutep VollzeitÜber uns Intro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 2 Wochen
Berlin, Deutschland Immutep VollzeitÜber uns Intro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitÜber uns Intro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitIntro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ....
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitIntroCompanyWe are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitCompany: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitCompany: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Clinical Supply Chain Manager
vor 2 Wochen
Berlin, Berlin, Deutschland Immutep VollzeitAbout ImmutepWe are an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. Our lead candidate, the LAG-3 based recombinant protein eftilagimod alfa, is currently undergoing pivotal clinical trials on a global scale.Job DescriptionClinical Trial Supply Strategy ManagerYou will work closely...
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Immutep | Clinical Trial Supply Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitIntro Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ. ...
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Immutep | Clinical Trial Supply Manager
vor 3 Wochen
berlin, Deutschland Immutep VollzeitIntroCompanyWe are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Immutep | Clinical Trial Supply Manager
vor 2 Wochen
Berlin, Deutschland Immutep VollzeitIntroCompany:We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and...
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Senior Clinical Supply Chain Manager
vor 2 Wochen
Berlin, Berlin, Deutschland Immutep VollzeitJob DescriptionClinical Trial Supply Manager sought for dynamic biotech company.About the CompanyWe are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France; Immutep is dedicated to bringing innovative treatment options to...
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Lead Clinical Supply Chain Manager
vor 2 Wochen
Berlin, Berlin, Deutschland Immutep VollzeitJob SummaryImmutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases, seeks a seasoned Clinical Procurement Manager.In this critical role, you will work closely with the Senior Director of Manufacturing to define and execute an optimal clinical trial supply strategy for Immutep's...
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Clinical Trial Manager
vor 7 Monaten
Berlin, Deutschland IQVIA VollzeitClinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...
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Clinical Procurement Manager
vor 3 Wochen
Berlin, Deutschland Immutep VollzeitWe are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. The company is publicly traded on the ASX and NASDAQ. remote with 10 % presence in the Berlin office Our lead candidate, the LAG-3 based recombinant protein eftilagimod alfa, is currently undergoing pivotal clinical...