Under the direction of the Director, Clinical Supplies Planning, the Associate Director Clinical Supplies Planning (ACP) will interface between the Clinical Supplies project managers and those involved in the planning of Clinical study projects for Shire. The ACP will attend clinical project meetings to gather relevant information, translating clinical trial protocol information into a study supply plan, forecast study product requirements, interacting and negotiation with key project stakeholders to provide delivery timelines and budget. The ACP will utilize relevant technology, including the ClinApps Smart Supplies forecasting tool to develop scenario based supply options.. The ACP will communicate opportunities and constraints to appropriate stakeholders, including Clinical Operations, Product Development, Clinical Supplies Production, and Quality Assurance.
The Associate Director Clinical Supplies Planning (ACP) will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Product Development, Clinical Supplies product and Quality Assurance for batch release planning.
The ACP will attend clinical project meetings to gain information, requested timings, and program/study information.
The ACP will collaborate with Clinical Programs for the creation of Clinical Packaging Requests.
The ACP will collaborate with Product Development for the development of drug product forecasts toward supply fulfillment and will use the ClinApps Forecasting module to create scenario based benchmarks for supply fulfillment.
The ACP will collaborate with Clinical Supplies Production to communicate project requirements and to develop a supply plan and timelines and to communicate to stakeholders.
The ACP will work in collaboration with the Clinical Supplies logistics function and the clinical supplies production function to identify cross-border requirements to ensure timely drug product movement and project success
Education & Experience Requirements:
BS degree in scientific / technical discipline, or significant job related experience dealing with global Clinical Supply planning, forecasting and use of IRT.
8+ years relevant Pharmaceutical Industry and/or contract supplier experience is preferred.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
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Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.