Associate Director, Clinical OperationsSan Francisco, California, United StatesAbout the JobKey ResponsibilitiesTeam ManagementProvide leadership and direction to Clinical Program LeadsRecruit, manage, train and develop staffMotivate and manage team members through setting of individual goals, providing on-going feedback, and performance evaluationsDelegate and provide general oversight of collaborations by providing program management level guidance to direct reportsProvide matrix support for staff in Clinical Operations on design initiatives to enable critical thinking, planning, prioritization, adherence to study needs and escalation as neededFacilitate team meetings by creating agendas, identifying priorities/working groups and distributing communications/minutesOversee staff expendituresManage resources according to department strategyReview staff deliverablesProgram Management, Cross-Functional Leadership & CollaborationStrategically represent Clinical Operations on cross-FMI initiatives and governance committees (LCT)Recognize and scope value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders as a trial/product design and plans are being built outContribute as a thought-partner for innovative study design and execution plansOversee Sponsored research including protocol and consent development, IRB submissions and interactions with Regulatory AuthoritiesInitiate contracting discussion with legal and external collaborator and maintain a comprehensive knowledge of each executed agreement to ensure progress against deliverablesMeet with internal stakeholders on alignment and towards achievement of project goals, adequate resource availability for delivery on commitmentsAssist in preparation for internal and external leadership presentations when requestedExternal Relationship ManagementEstablish strong partnership/relationship with internal and external stakeholdersEnsure proactive and effective communication internally and externallySupport partnership negotiations as opportunities for improvements ariseEnsure Consistent Execution of Clinical Operations Strategy, Processes and ProceduresContribute to design and development of Clinical Operations strategyOversee execution of department strategyMonitor execution of processes to determine points of failureIdentify and mitigate against study risks, partnering with the appropriate internal stakeholders to document any deviations, and analyze/build solutions as appropriateSupport regulatory authority and Sponsor audits and inspectionsEscalate compliance issues/risks to Clinical Operations, Medical and biopharma leadershipCreate and execute monthly, quarterly and annual financial, capacity and resource planning with department leadership team in close collaboration with Finance and HR Business PartnersCollaborate with internal Technology team in prioritization for development, testing and roll-out of new and updated systems and delegation of appropriate tasks to Principal and/or Senior CPLContribute to the Development and Execution of Clinical Operations Goals and InitiativesSponsor departmental or cross-functional projects and initiativesLead and/or sponsor internal initiatives to improve Clinical Operations processes and toolsMaintain Knowledge of Current GCP and CGP Regulations and Guidelines and Company Policies, SOPs and ProceduresOther duties as assigned