Clinical Supply Chain Lead - Neurology / Due Dil & Integration H/F

Ipsen

  • Dreux, Eure-et-Loir
  • CDI
  • Temps-plein
  • Il y a 1 mois
Title: Clinical Supply Chain Lead - Neurology / Due Dil & Integration H/FCompany: Ipsen PharmSciences SASJob Description:Summary / purpose of the positionIpsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.Research and development are key elements of our strategy, reflecting our commitment to improving patients’ lives and health outcomes. Bolstered by a culture of collaboration & excellence, Ipsen offers a unique proposition to 5,700+ employees committed to society.The Pharmaceutical Development organization is located across 5 Sites (France, UK, Ireland, US and Canada). The position is global and currently located in Europe. Regular presence at the Dreux site is expected.In respect to Good Manufacturing Practices and as part of the Global Clinical Supply Management department (GCSM), the clinical supply chain therapeutic area (TA) lead
  • 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.
This entails to be strongly involved in the continuous improvement process and knowledge management relating to the development of NCEs and Life cycle management of commercial products within the DPD department.Main responsibilities / job expectationsLeadership responsibilities
  • 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.
TA Supply Chain Lead responsibilities
  • 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
Due diligence and integration responsibilities
  • 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)
Continuous improvement responsibilities
  • 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.
QEEHS Responsibilities responsibilities
  • Respect and uphold the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
CSR Responsibilities:
  • Lead and implement actions for CSR development according to Ipsen guidelines.
Knowledge, abilities & experienceEducation / Certifications:
  • Pharmacist, engineer, degree in science or equivalent ideally with a PhD in science
Experience:
  • 7-10 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure
Languages:
  • Proficient in French and English
2 to 3 days minimum required on our Dreux site.Key Technical Competencies Required
  • 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
Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.

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