Associate Director, Clinical Operations, Therapeutics and Oncology

Associate Director, Clinical OperationsModerna is seeking an Associate Director, Clinical Operations to manage studies within the Clinical Operations, Therapeutics and Oncology Therapeutic Area. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position will be focused on ongoing studies in metabolic rare diseases, but the role will later support oncology.Here's What You'll Do:Accountable for delivery of assigned clinical study budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectivesDevelop operational strategy and clinical operations plans in support of execution of the Clinical Development PlanPartner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholdersLead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPsManage invoice and budget tracking for individual studies and provide input into budget forecasting activitiesSupport the selection, oversight, and management of CROs and other vendorsOversee site feasibility/capability assessments in collaboration with the CRO and cross-functional teamReview and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriateManage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operationsResponsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and proceduresAlong with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion LeadersPerform and document study level Sponsor Oversight of outsourced clinical activitiesCommunicate study-status, cost and issues to ensure timely decision-making by senior managementManage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programsOversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conductMaintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure complianceLead and/or participate in clinical operations workstreams related to departmental and operating model related initiativesDevelop and foster strong, collaborative relationships with key stakeholders both within and external to ModernaSupport program level deliverables/activities at the discretion of the Senior Director, Clinical OperationsProvide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertiseStrive for continuous improvement and more efficient ways of working in clinical developmentAct as a role model for Moderna's valuesHere's What You'll Bring to the Table:Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred.Robust experience in oncology required. Experience in immuno-oncology desirable. Experience in ultra rare disease desirable but not required. The ideal candidate has experience with high complexity clinical trials, and late-stage clinical trials, including inspection readiness activities.Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.Experience in GCP inspections/auditsOutstanding verbal and written