Associate Clinical Supplies Manager

Associate Clinical Supplies Manager 

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time salaried position.

The Associate Clinical Supplies Manager  under the guidance of the Clinical Supply Managers/Senior Clinical Supply Managers/Regional Manager CSM (CSM/S-CSM/RM-CSM) undertakes the activities required to lead and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage  activities of supply partners and functions (e.g. packaging and distribution, depots, logistics).

The Associate Clinical Supplies Manager  is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials for delegated tasks. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise. 

The Associate Clinical Supplies Manager  will have direct interaction with a client, sponsor or clinical vendors and may  be responsible upon request to participate in clinical supply calls where tracking of key actions and minute/note taking will be required.

May have responsibilities for supporting the training and mentoring of other Associate Clinical Supplies Manager’s within the team. To promote continuous improvement in all aspects of the job:  Coordination with PM, external vendors and client to ensure the highest level of client service.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Understand and translate clinical study protocol requirements into demand for drug product within a clinical study, with support of the Clinical Supply
  Managers/Senior Clinical Supply Managers/Regional Manager Clinical Supply Manager (CSM/S-CSM/RM-CSM)

• Creation of initial study drug projections and supply plan for clinical supply needs
  throughout life of study including multiple drug campaigns and appropriate drug strategies, with support of the CSM/S-CSM/RM-CSM

• Re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans, with support of the CSM/S-CSM/RM-CSM

• Create a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug, with support of the CSM/S-CSM/RM-CSM

• Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites, with support of the CSM/S-CSM/RM-CSM

• Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study, with support of the CSM/S-CSM/RM-CSM

• Provision of budget estimates in support of quotations for clients, with support of the CSM/S-CSM/RM-CSM

• Other duties as assigned

The Candidate:

• Bachelor's degree in a science, supply chain or related discipline, required

• Minimum one year relevant industry experience, required

• Understanding of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR), required

• Experience of using MS Office programs, wit