Clinical Supply Chain Project Manager

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 performance-driven with clear KPIs
• Plans and aligns effectively (steps, timelines etc.)
• Displays a commitment to best practice sharing and setting
• Promotes single point of accountabilities

Ensures Accountability

• Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects)
• Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
• Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
• Takes personal accountability for decisions, risk, actions, successes and failures, and fosters the same for others
• Follows through on commitment and makes sure others do the same

Communicates Effectively

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view
• Communicates transparently, “tells it how it is” while keeping the communication respectful
• Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes, adapted to the audience.
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HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Approximately 3-5 years’ experience in an equivalent job within the pharmaceutical industry with significant international exposure
• Experience managing complex investigational supplies for global clinical trials
• Experience in project management and facilitating communications in a highly matrixed environment

Knowledge & Experience (preferred):

• Experience with RTSM platforms and ability to partner with external CDMOs
• Experience in using advanced supply forecasting tools including advanced use of Excel

Education / Certifications (essential):

• Bachelor’s degree or global equivalent in pharmacy, engineering, operations and supply chain management

Education / Certifications (preferred):

• Certification in APICS, PMP, etc.
• Advanced education including MBA, Masters, PhD or global equivalent

Language(s) (essential):

• English

Language(s) (preferred):

• French

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