Clinical supply chain Project Manager

Ipsen Biopharmaceuticals Inc.; Dreux; On-site; EUR 90,000 - 130,000; Full time

Job summary

Ipsen is a global biopharmaceutical group accelerating transformative medicines in Oncology, Rare Disease and Neuroscience. We are seeking a Clinical Supply Chain Project Manager to define IMP design and supply chain strategy for clinical trials, coordinating with stakeholders to set up and maintain supply activities for Ipsen studies.

The role requires leading a cross-functional CSC sub-team, ensuring timelines, regulatory alignment, and mitigation of risks to avoid IMP stockouts while

Qualifications

• Experience in clinical supply chains and IMP design.
• Ability to coordinate cross-functional teams and CDMO management.
• Strong understanding of regulatory submissions and forecasting.

Responsibilities

• Facilitate the CSC sub-team for study setup incl. QA, packaging and distribution; manage CDMOs.
• Represent GCSM in study meetings; ensure milestones, timelines and assumptions align.
• Define project objectives and develop plans to ensure on-time supply and avoid stockouts.
• Validate strategy with the Clinical Supply Chain TA Lead.
• Collaborate with Global Regulatory Affairs and CMC Regulatory teams on strategy.
• Evaluate impact of changes to scope, schedule and costs.
• Escalate challenges and provide timely mitigations.
• Track performance and KPIs; forecast and report results.
• Present project progress at internal/external meetings.
• Represent GCSM in CMC project meetings and align with Asset Teams.
• Represent GCSM in Clinical Operations strategic meetings.

Skills

Project management

Cross-functional leadership

Clinical supply chain

Risk management

Regulatory knowledge

Job description

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