Clinical supply chain Project Manager

Title: Clinical supply chain Project Manager Company: Ipsen PharmSciences SAS About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram . Job Description: Job Title: Clinical Supply Chain Project Manager Division / Function: Pharmaceutical Development – Global Clinical Supply Manager’s Job Title: Clinical Supply Chain Therapeutic Area Lead WHAT - Summary & Purpose of the Position Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. Research and development are key elements of our strategy, reflecting our commitment to improving patients’ lives and health outcomes. In respect to Good Manufacturing Practices and as part of the Global Clinical Supply Management department (GCSM) , the Clinical Supply Chain Project Manager defines the IMP design and the associated supply chain strategy to ensure sufficient supply for clinical trials coordinates with his / her stakeholders the set up and the maintenance of the supply chain activities related to Ipsen clinical trials WHAT - Main Responsibilities & Technical Competencies Project management responsibilities Facilitate a cross functional CSC sub team , in charge of the set-up of clinical studies and which includes operational quality assurance, clinical packaging and distribution for internal projects and CDMO management for outsourced projects Represent GCSM within clinical study team meetings and ensure seamless alignment with clinical trials milestones (timelines, study design assumptions, recruitments assumptions etc) Define with its sub team the project and objectives while ensuring technical feasibility Develop with its sub team comprehensive project plans to ensure on time supply to patients and avoid IMPs stock out Validate the strategy with the Clinical Supply Chain Therapeutic Area Lead Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory teams to ensure alignment of regulatory strategy (submission filing, product references to be used) Evaluate impact of changes to the project scope, project schedule, and project costs Facilitate the sub team to solve complex challenges and provide mitigation plans in a timely manner to meet the business needs Escalate challenges / issues to management when needed Measure performance using appropriate project management tools and techniques Initiate and maintain risk assessment to minimize supply chain potential risks Track project performance, specifically to analyze the successful completion of short and long-term key goals ( forecasts KPIs, RTD, miss dose etc) Present the results and progress of projects under his/her responsibility at internal / external meetings As per delegation from the TA Lead: Can represent GCSM in CMC project meetings and ensure adequate alignment with Asset Teams objectives (timelines, priorities, need to initiate / review forecasts, communication escalation, anticipate risks and provide mitigation) Can represent GCSM within Clinical Operations strategic meetings and ensure seamless alignment with clinical development programs (overall plan including all studies of the program, study design assumptions etc) IMP design and clinical supply chain definition responsibilities Propose the design of the IMP kits in partnership with packaging team or CDMO Manage the labelling definition and approval Create and maintain comprehensive project documentation (IMP Design and Supply / Handling Manual / Supply Chain Flow Diagram, leaflets) Partner with the study forecaster to determine material needs for clinical trials Ensure all studies forecasts are revisited on a regular basis Organize resupply meetings with relevant cross functional departments Monitor closely the evolution of validated clinical study forecasts and share them with the CMC sub team Anticipate and assess impacts on changes on its clinical studies (addition of new countries, sites, number of patients, changes in protocols, etc). Challenge Clinical Project Managers when relevant and consolidate the new / updated forecasts in the appropriate systems. Report on the progress of studies and validate milestones Perform his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and harmonized ways of working / processes Manage quality events (deviations, change controls) in line with defined KPIs Continuous improvement responsibilities Defining and / or adjusting GCSM processes / ways of working and providing effective as well as continuous feedback. Organize and actively participate in lessons learnt exercises when needed. Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development. Be a promoter of continuous improvement processes and to guarantee the method. QEEHS Responsibilities Respect the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company. CSR Responsibilities: Apply and proactively contribute to actions for CSR development according to Ipsen guidelines. HOW - Behavioural Competencies Required Excellence in execution • Approaches priority setting and setting the stage through the lens of execution • Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society • Able to be focused and performanc