Varun S.
Clinical Project Lead @PSI CRO
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WORK HISTORY
Clinical Project Lead @PSI CRO
King of Prussia, PA, US
EDUCATION
The University of British Columbia
Master of Business Administration - MBA, Product and Service Management
ABOUT VARUN S.
Leading Clinical Operations in Precision Oncology & Radiopharmaceuticals | SSTR-PET, Dosimetry & Strategic Trial ManagementIn the rapidly evolving landscape of advanced therapeutics, I specialize in the operational mastery required to deliver complex Radiopharmaceutical and Oncology clinical trials. At a time when the industry is facing a critical shortage of talent capable of navigating \"hazard\" modalities, I bring a proven track record of managing the unique intersection of clinical execution, radiation safety, and intricate supply chain logistics.Currently a Clinical Project Lead positioning for Director-level challenges, I do not just execute protocols; I build the operational infrastructure that de-risks them. My expertise lies in translating aggressive clinical objectives into feasible, compliant site operations—preventing the \"operational risk debt\" that often stalls advanced modality studies.Core Operational Expertise:Radiopharma Strategy: Extensive experience managing SSTR-targeted radioligand therapies. I bridge the gap between clinical teams and technical requirements, overseeing critical dosimetry sub-studies, TIAC evaluation, and gamma counter standardization across global sites.Clinical Quality Leadership: I drive inspection readiness by designing robust monitoring plans and proactively managing protocol deviations. I have a strong focus on retraining and site engagement to ensure data integrity in complex operational environments.Vendor & Imaging Oversight: Expert in managing the \"vein-to-vein\" timeline, coordinating with imaging vendors for SSTR-PET uptake analysis and ensuring the seamless delivery of isotopes with strict half-life constraints.I am looking to bring this specialized leadership to an Associate Director or Director of Clinical Operations role, helping forward-thinking biotech organizations scale their most ambitious oncology programs.Competencies: Clinical Operations Strategy | Radiopharmaceuticals | Oncology | Risk-Based Monitoring (RBM)| Vendor Management | Dosimetry | FDA/EMA Regulatory Compliance | Cross-Functional Team Leadership
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