Posted in Other about 13 hours ago.
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 is accountable for the oversight and execution of assigned pre/post-POC interventional drug programs, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the Portfolio Operations Lead and clinical operations leadership team and will provide input into budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and mentoring and coaching of staff during execution of development trials.
This position has accountability for assuring strategic input and operational insight into the asset development planning lifecycle, including the Integrated Evidence Generation Plan (IEGP), Global Development Plan (GDP), Clinical Development Plan (CDP) and the implementation of patient-focused strategies for assigned programs.
Represents pre/post-POC Clinical Operations in Asset Teams, Portfolio and Operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to health authorities within their region/country of responsibility.
This position may represent Clinical Operations in due diligence activities for assets that may be in-licensed or acquired.
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