Clinical Supply Chain Forecast Manager

Overview

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. In respect to Good Manufacturing Practices and as part of the Global Clinical Supply Management department (GCSM), the Clinical Supply Chain Forecast Manager coordinates the forecasting and planning of clinical supply for IMPs to meet patient needs.

Responsibilities

• Drive clinical supply forecasting and budgetary requirements of clinical programs by providing consolidated estimates of IMPs to be produced compared to patient needs.
• Ensure adequate clinical forecast estimate / review is implemented for new and on-going clinical studies:
  • Organize review meetings with relevant cross-functional departments
  • Translate into the forecasting tool the design of any new clinical study according to the study protocol as well as recruitment projections (duration and speed of recruitment)
  • Monitor the evolution of validated clinical study forecasts and share them with coordination, planning, packaging and distribution teams: analyze deviations, decide on corrective actions, control readjustments, report progress, and validate milestones
• Align with the clinical manufacturing team to ensure proper planning of semi-finished goods production when required.
• When clinical packaging and distribution are performed internally, work with clinical procurement and packaging planning managers to translate clinical needs into production planning and ensure on-time supply to patients with no stock-outs of IMP; develop, coordinate and optimize forecasts over a 3- to 12-month period
• Anticipate and assess impact of changes in clinical studies managed by the GCSM team (addition of countries, sites, patients, protocol changes, etc.); propose mitigation plans, consolidate new/updated forecasts in appropriate systems, report progress and validate milestones
• If needed, communicate within CMC on the impact of changes observed or reported

IMP Estimation Process

• Coordinate and lead meetings for new clinical studies (IMP kick-off and IMP estimation meetings) with relevant stakeholders to ensure timely engagement of team members
• Ensure proper IMP risk assessment is implemented and maintained for each clinical study, including risks related to stockouts, distribution strategies, and study complexity

Transversal Management

• Coordinate with team members in a matrix environment

Continuous Improvement Responsibilities

• Lead change management initiatives with cross-functional teams internally and externally to Ipsen
• Quality:
  • Perform activities according to Ipsen Quality Management System
  • Contribute to site performance supporting KPI compliance (First Time Quality, On-time CAPA closed)
• Continuous improvement, QEHS and CSR:
  • Contribute to continuous improvement projects within Global Clinical Supply Management and/or wider Pharmaceutical Development
  • Promote continuous improvement processes and guarantee the method
  • Respect applicable good practices (GMP, GMPD, etc.) and Environmental, Health and Safety rules
  • Drive and implement actions to develop CSR within Ipsen’s orientations

QEEHS Responsibilities

• Respect applicable good practices (GMP, GMPD, etc.) and the Energy Environment Health and Safety rules through established procedures

CSR Responsibilities

• Apply and propose actions within Ipsen’s guidelines to develop CSR

Behavioural Competencies

• Excellence in execution: prioritization, clarity of goals, accountability, timelines, and KPIs; focus on patient and societal impact; promote accountability
• Ensures Accountability: single accountable referents per task; foster clear accountability; seek stakeholder input; personal accountability for decisions
• Communicates Effectively: asks open questions, respects different perspectives, communicates transparently and clearly; adapts messages to the audience

Knowledge & Experience

(essential)

• Approximately 3–5 years’ experience in an equivalent role within the pharmaceutical industry with significant international exposure
• Experience managing complex investigational supplies for global clinical trials
• Experience in project management and facilitating communications in a highly matrixed environment

(preferred)

• Experience using advanced supply forecasting tools including advanced Excel
• Experience with RTSM platforms and ability to partner with external CDMOs

Education / Certifications

(essential)

• Bachelor’s degree or global equivalent in pharmacy, engineering, operations and supply chain management

(preferred)

• APICS, PMP certification, or equivalent
• Advanced education including MBA, Master’s, PhD or global equivalent

Languages

• Essential: English
• Preferred: French

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