Clinical Operations Lead, Ophthalmology/BioPharma
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About The Position
This position is accountable for the oversight and execution of assigned pre- and/or post-POC interventional drug programs and all associated clinical trials. This may also include Clinical Pharmacology healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). This position has accountability for assuring strategic input and operational insight into the asset development planning lifecycle, including integrated evidence generation (iEGP), Global Development Plan (GDP), Clinical Development Plan (CDP) and the implementation of patient-focused strategies for assigned programs and trials. Represents pre- and/or post-POC Clinical Operations in Asset Teams, Portfolio and Operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable. This position is accountable to the Portfolio Operations Lead and the clinical operations leadership team(s) 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. 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. Report to Portfolio Operations Lead or above. Provides functional leadership and management globally of ≥ 3 direct reports, including international direct reports.
