- Master degree in Sciences or equivalent, or other relevant disciplines.
- At least 8 years experience in Project Management.
- Experience in Clinical Trials and/or Drug Supply Management.
- Excellent knowledge of written & spoken English - knowledge of French & other languages are an asset.
- Knowledge of Clinical Trial Supplies Operations (Labelling/Pack/Ware House/Distribution) are required for this role.
- Product & Production knowledge is an asset.
- GCP/ GMP/ Quality standards.
- Customer Orientation and good communications skills are a MUST.
- Role Flexibility, Planning, Analytical Thinking, Problem Solving are required for the role.
- People interaction: Motivating, Effective Communication, Project Management, Coordinating.
- Prioritisation is crucial for this role.
We are currently seeking a Portfolio Manager to join our Technical R&D GMP Manufacturing and Clinical Supply department. If interested, please read further.
The Portfolio Manager ensures an end to end logistic oversight at project/study level covering activities from forecasting till Investigational Medicinal Product (IMP) reconciliation.
As the Point of Contact (POC) for the Project Development Lead (PDL) and the Technical Development Lead (TDL), you are responsible for the timely availability of Investigational Medicinal Products (IMPs) for clinical studies.
- Technical R&D (TRD) representation for Clinical Develop Plan development and execution, as assigned by department head.
- Logistic Project Management for different CDPs
- Conduct clinical supplies forecasting, long and short term.
- TRD Point of contact for clinical supplies and distribution, including planning and troubleshooting.
- Feasibility & risk assessment at project/study level at the time of forecasting.
- Link with planning, operations for feasibility evaluation of clinical supply operations.
- Review and input on Concept Protocol.
- Logistic oversight from forecasting till IMP reconciliation.
- Develop and manage clinical supply budgets (TRD responsibility).
- Support clinical sites and site audits, as needed.
- Conduct lot allocations for studies and manage (re)supplies.
- Responsible for timely availability of IMPs (Clinical, Commercial, Competitor) to sites for on-time start of trials, communication and mitigation of issues/delays.
- Communication up through GMP Mfg leadership and out to key stakeholders.
- Follow-up of milestones to ensure the timely release of clinical supply to ensure IMP availability in accordance with the needs.
- KPI reporting.
- Support IT (SAP) improvements as needed; use and maintain existing IT (SAP) systems.