Description Position Summary Reporting to the Chief Medical Officer, the Vice President of Clinical Operations will be responsible for building and leading a team of clinical operations professionals who will oversee the strategy for implementation as well as execution of all AnaptysBio sponsored clinical trials. Working with cross-functional leaders, the successful candidate will ensure the appropriate department infrastructure is in place to support the Company\u2019s antibody clinical trial programs. This individual will be responsible for leading all operational aspects of the Company\u2019s clinical trials conduct from study concept through to report writing in support of license applications. Provide strategic and technical guidance to ensure clinical trials are properly defined, planned and executed. Lead and direct the clinical operations team responsible for management and execution of all clinical trials. This includes ensuring cost, quality, vendors are managed, timelines of multiple programs are met and site qualifications and initiation. Lead and directs the building of department infrastructure, including developing, retaining, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs. Optimize and implement SOPs, processes, communication, and infrastructure within Clinical Operations Department to support company goals including Regulatory filings. Maintain real-time, live dashboards for management review of program status, risk plans and mitigation, and document control. Requirements Education & Experience: BA\/BS in related life sciences field and 20 years of progressive clinical operations experience in pharmaceutical\/drug development and including\u00a0at least 10 years of strong hands-on experience leading and managing clinical operations team and trials execution, preferably in antibody\/biologics experience globally. Expertise in the areas of drug development, operations and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing pre-clinical through all clinical phases. Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, ICH, and GCP\u00a0requirements (and\/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance.
Website : http://www.anaptysbio.com