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.

Job Description

Summary & Purpose of the Position
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

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
• 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
• 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
• 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 against key goals
• Present results and progress at internal / external meetings
• As per delegation from the TA Lead can represent GCSM in CMC project meetings and Clinical Operations strategic meetings

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
• Report on the progress of studies and validate milestones
• Perform his / her mission according to regulatory guidance and processes
• Manage quality events (deviations, change controls) in line with defined KPIs

Continuous improvement responsibilities

• Defining and / or adjusting GCSM processes / ways of working
• Organize and actively participate in lessons learnt exercises
• Contribute to continuous improvement projects
• Be a promoter of continuous improvement processes

QEEHS Responsibilities

• Respect Good Practices (BPF, BPD) and rules of Energy Environment Health and Safety

CSR Responsibilities

• Apply and proactively contribute to actions for CSR development according to Ipsen guidelines

Behavioural Competencies Required

Excellence in execution

• Approaches priority setting and execution
• Establishes clarity about goals, accountabilities, timelines
• Focused and performance-driven with clear KPIs
• Plans and aligns effectively
• Commitment to best practice sharing
• Promotes single point of accountabilities

Ensures Accountability

• Ensures single accountable referents per task/project
• Builds environment where people ask for clarification
• Consults stakeholder views and makes decisions by consent
• Takes personal accountability
• Follows through on commitment

Communicates Effectively

• Asks open questions and shows respect
• Communicates transparently
• Builds clear messages adapted to audience

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

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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