Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
This position will oversee and provide strategic direction for the global execution of study start up activities for all Clinical Development Studies (Early Development & Late Stage) which may include (but not limited too): Site & Country Feasibility, Contract & Budget Negotiations, Site Payments, Regulatory Document Collection to support site initiation, ICF, site qualification & initiation visit coordination, and IRB / EC submissions.
This position will be responsible for supporting identification of and execution of interventional trial support strategies aimed at increasing productivity and quality while decreasing cycle times and cost and for the development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with functions outside of M&D, and across the early and late stage (including MA and RX+, where applicable ) clinical organizations for the relevant support functions.
This position will be a member of the Extended Clinical Operations Leadership Team (COLT) and will provide input into sub-division structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.
Essential Job Responsibilities:
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