Clinical Supply Chain Project Manager

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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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 5700 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

Project management responsibilities

- Facilitate a cross functional CMC 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 (timelines study design assumptions recruitments assumptions etc)

- Define with its sub team the project scope 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 to ensure

alignment of regulatory strategy (submission filing product references to be used)

- 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 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 minimize 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 the results and progress of projects under his/her responsibility at internal / external meetings

- As per delegation from the Supply Chain TA Lead:

- Can 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)

- Can 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)

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)

- Review Clinical Operations documentation (CRO scope of work for example)

- Define with the Forecast Manager the initial needs to support clinical trials

- Ensure all studies forecasts are revisited on a regular basis with the support of the Forecast Manager

when needed:

- Organize 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 the new / updated forecasts in the appropriate systems.

- Report on the progress of studies and validate milestones

- Perform his / her mission according to (i) the up-to-date internal and external regulatory guidance and

process (ii) and harmonized ways of working / processes as defined by the Portfolio Management and

Processes Team

- Manage quality events (deviations change controls) in line with defined KPIs

Continuous improvement responsibilities

- Support the Process and Compliance Project Manager while defining and / or adjusting GCSM processes /

ways of working and providing effective as well as continuous feedback.

- Organize 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 to guarantee the method.

QEEHS Responsibilities responsibilities

- Respect the Good Practices applicable (BPF BPD ) the rules of Energy Environment Health and Safety

through the procedures applicable within the company.

CSR Responsibilities:

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

Knowledge abilities & experience

Education / Certifications:

Pharmacist engineer or university graduate (BAC5) with a postgraduate degree in health industry

Experience:

Minimum 5 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 organizational skills

Hybrid model : 3 days on site & 2 days on remote

Nous nous engageons à créer un lieu de travail où chacun se sent écouté valorisé et soutenu où nous incarnons The Real Us*. La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de linclusion et de légalité des chances. Lorsque nous intégrons des modes de pensée diversifiés nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin daménagements ou daide pendant le processus de candidature veuillez en informer léquipe de recrutement. Ces informations seront traitées avec soin et nauront aucune incidence sur le résultat de votre candidature. *Soyons nous-même