Coordinator - Clinical Supply Portfolio and

**Title**:
Coordinator - Clinical supply portfolio and forecasting

**Company**:
Ipsen PharmSciences SAS

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 will be located in France, dedicated to the development of small molecules, peptides and devices.

In respect to Good Manufacturing Practices and as part of the Drug Product Development team, the Clinical supply portfolio and forecast coordinator participates in the global management of clinical demand for all clients from R&D and GMA for all clinical studies managed by the Global Clinical Supply Management department. This includes the alignment with key stakeholders (Clinical Operations, Production teams and Quality teams). This position is also responsible to support robust processes for forecasting and planning for clinical production in order to avoid any product stock-outs.

**Main responsibilities / job expectations**

**First responsibilities**
- Clinical forecasting responsibilities:

- Participate the review of the clinical studies portfolio with Clinical Operations and other teams: schedule and lead quarterly preparatory meetings with relevant stakeholders to obtain most up to date information on the status of Ipsen’s clinical studies (on-going and new studies).
- Support clinical supply forecasting and budgetary requirements of clinical program by providing consolidated estimates of IMPs to be produced compared to patient’s needs.
- Participate in clinical forecast review as appropriate depending on the program.
- Align with clinical manufacturing team to ensure proper planning of semi-finished goods production when required.
- When clinical packaging and distribution are to be performed internally, work in coordination with the manager for clinical portfolio and forecasting, clinical procurement, and the packaging planning manager to ensure seamless translation of the of clinical needs into production planning; and to consider all clinical studies. Main objective is to ensure on time supply to patients with no stock outs of IMP. To do so, participate in the development, coordination, and optimization of the clinical forecasts over a 3-to-12-month period
- Anticipate and assess impact on changes in clinical studies managed by the GCSM team (addition of new countries, sites, number of patients, changes in protocols, etc.). Propose mitigation plans for facilitating prioritization decisions. 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
- If needed, communicate, and follow up within CMC on the impact on the schedule to any changes observed or reported.
- IMP estimation process:

- Coordinate and participate in meetings for new clinical studies (IMP kick off meeting, IMP Risk Assessment, IMP Quantity Endorsement) and manage follow up actions
- Participate in IMP risk assessment implementation and maintenance for each clinical study, including but not limited to risks linked to stock out, distribution strategies, complexity of the study.
- Participate in the parametrization and maintenance of the forecasting tool for new and ongoing studies according to the study protocol as well as recruitment projections
- Monitor closely the evolution of validated clinical study forecasts and share updates with the Manager for Clinical Forecasting and Portfolio as necessary.
- Transversal management responsibilities
- Coordinate with team members in a matrix environment

**Second responsibilities**
- Quality:

- Perform their activities according to Ipsen Quality Management System
- Contribute to the performance of the site supporting the compliance of KPIs (First Time Quality, On time CAPA closure)
- Continuous improvement, QEHS and CSR:

- 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,
- Respect and ensure respect for applicable good practices (GMP, GMPD, etc.) and Environmental, Health and Safety rules through the procedures in force within the establishment,
- Drive and implement actions to develop CSR within the framework of Ipsen's orientations.

**QEEHS Responsibilities**:

- Respect the applicable best practices (B