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Title
Chief IP Counsel
Location : Idaho, York
Refer job # KBET340573
 
Job Responsibilities and Requirements: We are seeking a Director Clinical Operations who will be responsible for the oversight and strategic direction of assigned clinical programs. The Director/Senior Director will ensure milestones are achieved and aligned with corporate goals. The Director will report into the Vice President of Clinical Operations and Pharmacovigilance. FUNCTIONAL TASKS - Lead and develop the clinical operations function at Sorrento Therapeutics - Lead and oversee and manage study managers - Oversee selection and management of CROs and other related clinical trial service providers - In conjunction with CRO and Clinical team. evaluate feasibility of clinical trials and develop timelines and milestones - In collaboration with the R & D Q/A function, Develop Clinical Operations compliance program and ensure clinical trials are conducted in accordance with SOPs, GCP and ICH guidelines - Create risk mitigation strategies for clinical trials and associated action plan and resolution including CAPAs - Ensure a resource plan is in place for all trials to ensure all key deliverables are met - Provide leadership to Sorrento CRO Clinical Trials Oversight Committee Ensure that all aspects of clinical trial data collection, management and generation of clinical trial data analysis sets are fit for regulatory submission - Actively collaborate with clinical, regulatory. QA, finance and legal to ensure clinical program goals are delivered in compliant and cost-effective manner - Support the generation of data as needed to meet interim reviews of safety and efficacy reports to support Data Monitoring Committees, DSMB, IND Annual Reports, ad-hoc queries, etc. - Support generation of data as needed to meet interim reviews of safety and efficacy reports to support Data Monitoring Committees, DSMB, IND Annual Reports, ad-hoc queries, etc. PROFESSIONAL/TECHNICAL SKILLS - Minimum of 12 years Clinical Operations experience in the pharmaceutical, biotech or CRO industry - Proven leadership skills in Phase I-IV clinical trials as well as with direct reports or contractors - Possesses a thorough understanding of cross functional clinical processes including management, biostatistics, and medical writing - Strong working knowledge in Good Clinical Practice and ICH Guidelines - Effective communication (written and verbal) and strong interpersonal and organizational skills - Progression of clinical trial management experience - Experience in oncology, cellular medicine and/or pain strongly preferred EDUCATION - Minimum of a Bachelor s degree in scientific area - Advanced degree or additional professional training a plus Sorrento offers a competitive salary as well as a comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks PTO, plus stock options.
 
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