Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Associate Director, Clinical Supply Chain manages the clinical supply activities for assigned clinical programs. The Associate Director develops and maintains clinical supply plans to include investigational products and co-meds ensuring accurate and continuous supply to assigned clinical programs while reducing risk and minimizing waste.
Essential Functions of the Job (Key responsibilities)
Represent Clinical Supply Chain on Clinical Study Teams and provide a high service level to internal stakeholders.
Work with Clinical Operations to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
Develop and maintain clinical supply and inventory plans for assigned programs; leads cross functional clinical supply status meetings.
Coordinate sourcing of co-meds working closely with Procurement and Clinical Operations.
Generate and monitor co-med budgets and spend working closely with Clinical Operations and Finance.
Ensure delivery of co-meds to Clinical Operations and Technical Operations for further packaging and distribution.
Manage the relationship and oversee daily activities for co-med sourcing vendors.
Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
Coordinate efforts between Project Management, Clinical Operations, Technical Operations and maintains forecast and timelines for clinical supplies for assigned programs.
Maintain routine and timely communication with Technical Operations of any changes in clinical supply forecasts or study timelines.
Facilitate discussions and decisions on label and packaging design, as needed.
Support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply activities in the system.
Participate in development and maintenance of standard operating procedures (SOPs).
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor degree in a related field.
3-4 years work experience in the pharmaceutical industry.
Experience in clinical supply chain and/ or clinical study operations is required.
Knowledge of global clinical trials and the drug development process.
Knowledge of global pharmaceutical regulatory requirements (e.g. cGMP, GCP).
Knowledge of IRT system setup and functionality and proficiency with Excel modeling.
Competence with computers and technology is essential; to include extensive experience with MS Office Applications is required.
Experience with forecasting and inventory management tools is preferred
Strong organizational, analytical, problem solving, and communication skills.
Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet deadlines.
Experience in vendor oversight and managing external partnerships
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.