Clinical Supply Chain Lead - Neurology / Due Dil & Integration H/F
Ipsen
- Dreux, Eure-et-Loir
- CDI
- Temps-plein
- ensures with his / her team the set up and the management of the supply chain related to Ipsen clinical trials
- contributes to Due Diligence evaluation with regards to supply chain aspects and, following new assets and / or new company acquisition, ensures new study onboarding in its TA for a smooth integration into Ipsen processes & ways of working
- performs his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and within time, resources and cost agreed by the company.
- Lead a team in a matrix and global environment,
- Maintain staff by recruiting, selecting, orienting employees,
- Define the annual objectives of his/her group in alignment with the objectives of Pharmaceutical Development & R&D. Lead his/her team by mobilizing it around its objectives and evaluates the outcomes,
- Provide effective and continuous feedback, through employee recognition, rewards, performance appraisal and development discussions,
- Define and propose the training/development plan for his/her team, ensure its implementation and carry out the follow-up. Develop, monitor and guide the levels of expertise of his/her team in terms of knowledge and know-how. Ensure continuous professional development of its employees,
- Anticipate any resource needs to ensure that his / her team provides deliverables in time, with the expected quality.
- 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). Develop close collaboration with CMC Leads.
- 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)
- Define and maintain long term clinical packaging and distribution plans (time and quantities) in its therapeutic area to facilitate strategic decisions (make versus buy, activities prioritization)
- Lead, influence and support a team in charge of the set-up of clinical studies from a supply chain perspective:
- Facilitate a cross functional CMC sub team which includes operational quality assurance, clinical packaging and distribution for internal projects and CDMO management for outsourced projects
- Develop with its sub team comprehensive project plans to ensure on time supply to patients and avoid IMPs stock out
- 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)
- Review Clinical Operations documentation (CRO scope of work etc)
- Ensure all studies forecasts are revisited on a regular basis
- Conduct supply chain risks analyses
- Review and approve IMP Design and Supply documentation / Handling Manual / Supply Chain Flow Diagram
- Ensure alignment of budget between CMC teams and CDMO management team
- Based on a tight collaboration with the Portfolio Management and Processes team as well as CDMO Management team, ensure harmonized ways of working / processes are applied within GCSM department
- Present the results and progress of projects under his/her responsibility at internal / external meetings
- As part of potential new companies and / or new assets acquisitions, contribute to Due Diligence evaluations with regards to supply chain aspects
- For deals signed, lead integration of assets and / or companies acquired within its TA according to processes defined and to ensure business continuity (Perform SC gap analysis, study set up robustness, onboard programs in internal QMS etc)
- Contribute to continuous improvement projects within the GCSM and/or wider Pharmaceutical Development.
- Be a promoter of continuous improvement processes and to guarantee the method.
- Respect and uphold the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
- Lead and implement actions for CSR development according to Ipsen guidelines.
- Pharmacist, engineer, degree in science or equivalent ideally with a PhD in science
- 7-10 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure
- Proficient in French and English
- Experience and knowledge on handling large and complex clinical trials (preferred)
- Excellent communication skills / networking
- Experience in project management
- Team player with ability to work in a matrix environment
- Strong organizational skills