Hiring: Director, Submission Project Management Lead Company: Kite Pharma Location: Thousand Oaks, CA Job Posted Time: 2026-09-12 11:39:59 Target Skills & Keywords : Project Management, Regulatory Compliance, Six Sigma, Workday About the job Experience: •6 years of pharmaceutical/biotech or relevant industry experience Required Skills: •The Director, Submission Project Management serves as the strategic and operational leader accountable for planning, integrating, and executing activities that enable successful major regulatory submissions, including BLAs, sBLAs, and global regulatory filings. •This role provides leadership across Clinical Development, Clinical Operations, Data Management, Biostatistics, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, Safety, Quality, and other cross-functional teams to ensure submission readiness, operational excellence, and achievement of critical filing milestones. •While regulatory submission planning and execution remain the primary focus, this role may also provide project management leadership for select Development initiatives, including process improvement efforts, Product Team support, and Development sub-team planning and execution, as business priorities require. •Submission Strategy & Leadership •Accountable for end-to-end oversight of clinical trial data readiness to support BLA, sBLA, and other major global regulatory filings. •Develop and drive integrated submission strategies that align clinical, operational, data, regulatory, and functional activities required for successful filings. •Serve as the senior operational lead for submission planning, execution, and readiness across cross-functional development teams, with the ability to flex into broader Global Project Manager accountabilities as portfolio and business priorities require. •Partner with Development and Regulatory leadership to establish filing strategies, key milestones, risk mitigation plans, and execution priorities. Qualifications: •Doctorate + 6 years of pharmaceutical/biotech or relevant industry experience •Master's + 10 years •Bachelor's + 12 years •Extensive pharmaceutical or biotechnology industry experience supporting late-stage development and major regulatory submissions. •Demonstrated success leading complex regulatory filing initiatives, including BLAs, sBLAs, NDAs, MAAs, or equivalent global submissions. •Comprehensive expertise in clinical trial execution, clinical data generation, data review, data management, statistical analysis, medical writing, safety, quality, and regulatory submission processes. •Demonstrated success in leading large-scale, cross-functional initiatives and influencing senior leadership in a matrixed organization. •Demonstrated capacity to flex between submission execution, process improvement, and broader Development project management accountabilities while maintaining clear prioritization and leadership alignment. •Strong executive presence with the ability to communicate complex issues, strategic trade-offs, and recommendations to senior leadership. •Demonstrated success leading continuous improvement initiatives. Compensation: •$226,185 - $292,710 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!