Clinical supply chain Project Manager - CDD 12 mois

Lamacompta; Dreux; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Une entreprise biopharmaceutique recherche un directeur de projet de chaîne d'approvisionnement clinique pour gérer des études cliniques complexes. Le candidat idéal a un diplôme dans l'industrie de la santé et 5 ans d'expérience, avec d'excellentes compétences en gestion de projet et communication. Ce rôle implique la définition de stratégies d'approvisionnement et la collaboration avec diverses équipes pour assurer le bon déroulement des études cliniques.

Qualifications

• Minimum 5 ans d'expérience dans un rôle similaire dans l'industrie pharmaceutique.
• Exposition internationale significative.
• Langues: maîtrise du français et de l'anglais.

Responsabilités

• Définir la stratégie d'approvisionnement et de gestion des essais cliniques.
• Faciliter les études cliniques et le plan d'approvisionnement.
• Gérer les événements de qualité et contribuer à l'amélioration continue.

Connaissances

Gestion de projet

Communication

Réseautage

Organisation

Formation

Diplôme de pharmacien ou d'ingénieur (BAC+5) avec un diplôme supérieur dans l'industrie de la santé

Description du poste

Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience, and Rare Diseases. We are committed to discovering new treatments for areas with high unmet medical needs and enhancing patients' quality of life. Research and development are central to our strategy, reflecting our dedication to bettering patients’ lives. Supported by a culture of collaboration and excellence, Ipsen employs over 5,700 people committed to societal impact.

The Pharmaceutical Development organization operates across four sites (France, Ireland, UK, and Canada). The position is based in France, focusing on the development of small molecules, peptides, and devices.

As part of the Global Clinical Supply Management (GCSM) department and in compliance with Good Manufacturing Practices, the Clinical Supply Chain Project Manager is responsible for:

• Defining the IMP design and supply chain strategy to ensure adequate supply for clinical trials.
• Coordinating with stakeholders to set up and maintain the supply chain plan for Ipsen's clinical trials.

This role involves active participation in continuous improvement processes and knowledge management related to the development of New Chemical Entities (NCEs) and lifecycle management of commercial products within the DPD department.

Main Responsibilities / Job Expectations

Project Management:

• Facilitating a cross-functional CMC sub-team responsible for clinical study setup, including operational quality assurance, clinical packaging, distribution, and CDMO management.
• Representing GCSM in clinical study team meetings to ensure alignment with trial milestones.
• Defining project scope, objectives, and ensuring technical feasibility.
• Developing comprehensive project plans for on-time supply and avoiding stockouts.
• Validating strategies with the Clinical Supply Chain Therapeutic Area Lead and collaborating with Regulatory Affairs teams.
• Evaluating impacts of scope, schedule, and cost changes.
• Leading resolution of complex challenges and providing mitigation plans.
• Escalating issues when necessary and tracking project KPIs.
• Representing GCSM in various strategic meetings and ensuring alignment with clinical development programs.

IMP Design and Supply Chain Definition:

• Proposing IMP kit designs in partnership with packaging teams or CDMOs.
• Managing labeling and documentation.
• Reviewing and revisiting clinical trial forecasts regularly.
• Monitoring changes and assessing impacts on studies.

Reporting and Compliance:

• Reporting progress and validating milestones.
• Managing quality events and contributing to continuous improvement.
• Supporting process and compliance initiatives within GCSM.
• Participating in lessons learned exercises and promoting continuous improvement processes.

QEEHS and CSR Responsibilities:

• Adhering to Good Practices (BPF, BPD, etc.) and safety/environmental policies.
• Contributing to CSR development initiatives per Ipsen guidelines.

Knowledge, Abilities & Experience

Education / Certifications: Pharmacist, engineer, or university graduate (BAC+5) with postgraduate health industry degree.

Experience: Minimum 5 years in a similar role within the pharmaceutical industry, with significant international exposure.

Languages: Proficient in French and English.

Key Technical Competencies:

• Experience with large, complex clinical trials (preferred).
• Excellent communication and networking skills.
• Project management experience.
• Ability to work effectively in a matrix and global environment.
• Strong organizational skills.