Clinical Supply Chain Project Manager

Ipsen; Dreux; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A biopharmaceutical company in France seeks a Clinical Supply Chain Project Manager responsible for defining supply chain strategies for clinical trials. The ideal candidate has over 5 years of experience in the pharmaceutical sector and must be proficient in French and English. This role includes coordination of clinical supply plans, facilitating cross-functional teams, and developing project strategies to ensure timely delivery. The position offers a hybrid work model, requiring 3 days on-site and 2 days remote.

Qualifications

• Minimum 5 years experience in an equivalent job in the Pharmaceutical Industry.
• Proficient in French and English.

Responsabilités

• Define the IMP design and supply chain strategy for clinical trials.
• Coordinate the maintenance of the supply chain plan.
• Facilitate cross-functional CMC sub-team operations.
• Develop comprehensive project plans to avoid IMP stock-outs.
• Represent GCSM in clinical study meetings and manage risk assessments.
• Organize review meetings with relevant departments.

Connaissances

Project Management

Communication Skills

Organizational Skills

Teamwork

Technical Knowledge

Formation

Postgraduate degree in health industry

Description du poste

Title

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.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https : / / www.ipsen.com and follow our latest news on LinkedIn and Instagram.

Job Description

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. 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 4 Sites (France, Ireland, UK and Canada). The position is located in France, dedicated to the development of small molecules, peptides and devices. 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 plan related to Ipsen clinical trials. 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 Expectations

• Define the IMP design and the associated supply chain strategy to ensure sufficient supply for clinical trials.
• Coordinate with stakeholders the set‑up and maintenance of the supply chain plan related to Ipsen clinical trials.
• Involve in continuous improvement process and knowledge management relating to development of NCEs and lifecycle management of commercial products.
• Facilitate a cross‑functional CMC sub‑team in charge of the set‑up of clinical studies, including 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 the sub‑team the project scope and objectives while ensuring technical feasibility.
• Develop comprehensive project plans to ensure on‑time supply to patients and avoid IMP stock‑outs.
• Validate 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, schedule, and 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 minimise supply‑chain potential risks.
• Track project performance, specifically to analyze the successful completion of short and long‑term key goals (OTIF, forecasts KPIs, RFT etc).
• Present results and progress of projects under responsibility at internal/external meetings.
• 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).
• Represent GCSM within Clinical Operations strategic meetings and ensure seamless alignment with clinical development programmes.
• 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.
• Review Clinical Operations documentation (CRO scope of work for example).
• Define with the Forecast Manager the initial needs to support clinical trials, and ensure all studies forecasts are revisited regularly.
• Organise review 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 new/updated forecasts.
• Report on the progress of studies and validate milestones.
• Keep mission in line with internal and external regulatory guidance and harmonised working practices.
• Manage quality events (deviations, change controls) in line with defined KPIs.
• Support the Process and Compliance Project Manager in defining or adjusting GCSM processes and providing continuous feedback.
• Organise 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 guaranteed method.
• Respect Good Practices applicable (BPF, BPD, ...), and EU Health, Environment, Safety rules through the applicable procedures within the company.
• Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.

Knowledge, Abilities & Experience

Education / Certifications

• Pharmacist, engineer or university graduate (BAC+5) with a postgraduate degree in "health industry".

Experience

• Minimum 5 years experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure.

Languages

• Proficient in French and English.

Key Technical Competencies Required

• Experience and knowledge on handling large and complex clinical trials (preferred).
• Good communication skills/networking.
• Experience in project management.
• Team player with ability to work in a matrix and global environment.
• Strong organisational skills.

Hybrid Model

3 days on site & 2 days on remote.

Equal Employment Opportunity Statement

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.