Title: Clinical Supply Chain Forecast Manager
Company: Ipsen Biopharm Ltd
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:
WHAT - 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.
Research and development are key elements of our strategy, reflecting our commitment to improving patients' lives and health outcomes.
WHAT - Main Responsibilities & Technical Competencies
Clinical forecasting responsibilities
- Drive clinical supply forecasting and budgetary requirements of clinical program by providing consolidated estimates of IMPs to be produced compared to patient's needs.
- Ensure adequate clinical forecast estimate / review is implemented for new / on-going clinical studies: Organise review meetings with relevant cross functional departments
- Translates into the forecasting tool the design of any new clinical study according to the study protocol as well as the recruitment projections (duration and speed of recruitment).
- Monitors closely the evolution of validated clinical study forecasts and shares them with the coordination, planning, packaging and distribution teams: analyzes deviations, decides on corrective actions, controls readjustments, reports on the progress of studies and validates milestones
- 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 tandem with clinical procurement and packaging planning manager to ensure seamless translation of the of clinical needs into production planning and take into account all the clinical studies.
- Main objective is on time supply to patients with no stock outs of IMP. To do so, develop, coordinate and optimize 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 priorisation 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 lead meetings for new clinical studies (IMP kick off meeting & IMP estimation meeting) involving relevant stakeholders to ensure on time engagement of each team members.
- Ensure proper IMP risk assessment is implemented and maintained for each clinical study, including but not limited to risks linked to stock out, distribution strategies, complexity of the study.
Transversal management responsibilities
- Coordinate with team members in a matrix environment
Continuous improvement responsibilities
- Lead change management initiatives with cross functional teams both internally and externally to Ipsen
- Quality: Perform its 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 closed)
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