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Director of Clinical Operations - Seattle

Neoleukin Therapeutics, Seattle Washington

Director/Sr Director, Clinical Operations
DESCRIPTIONNeoleukin Therapeutics is looking for an experienced, independent leader in clinical operations to join our fast-growing organization. This key position will oversee clinical trials (pre-IND through Phase 1-4) for oncology and autoimmunity contributing to our clinical development program(s). If you are a resourceful, collaborative clinical development expert looking for an opportunity to build something unique, please apply!
RESPONSIBILITIESEstablish and supervise a team of clinical research professionals, including Clinical Research Associates, Clinical Trial Managers, Documentation Specialists, Biostatisticians, etc.Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial executionOversee clinical operations, including study management, budgets and timelinesSupervise data management, safety management, and study project plans, including communicationInterface with CROs and clinical site Investigators and staff to ensure optimal site relationships (15% travel expected)Review clinical study protocols, informed consent forms, clinical study reports and other clinical documentsAssist with preparation of pre-IND, IND, BLA and other regulatory filingsCollaborate with CMC to assist with drug labeling, packaging, storage and distribution for clinical trialsServe as monitor or co-monitor for studies, if neededPlan and participate in site initiation visits, study meetings, and vendor meetings, as needed
QUALIFICATIONSMaster’s degree in a scientific or healthcare discipline preferredMinimum of 8 years of experience in clinical drug development in the pharmaceutical/biotech industry required, at least 3 years of early-phase clinical drug development required, and at least 3 years of direct study management work preferredExperience in the oversight of all operational aspects of clinical studies requiredExperience managing clinical trials, CROs, multiple vendors, budgets, and timelinesExperience monitoring clinical studies and conducting site visits, including Site Initiation Visits etc.Experience writing clinical protocols, ICF, and CSR requiredExperience in oncology and biologics preferredExperience leading a team of collaborative clinical professionalsStrong leadership skills and self-awareness, with proactive and positive management approachExcellent oral, written, and medical communication skills requiredAbility to thrive in a fast-paced and entrepreneurial environmentAbility to function at a high level in a team setting whether leading the group or contributing independentlyFlexibility to adapt to changing needs in real timeAbility to build strong relationships with co-workers of various backgrounds and expertiseExcitement about the vision and mission of Neoleukin Therapeutics
Applications can be submitted to [email protected] Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.
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