| Location | San Diego, CA |
Reporting into the PMO through the Sr. Director, Program Management, the Sr. Manager / Associate Director, Program Management - Clinical, Medical & Regulatory (CMR) leads the strategic planning, execution, and delivery of clinical programs uniting Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions and deliverables. This role operates as an embedded, matrixed member of the CMR organization while remaining part of the enterprise PMO, with close collaboration across cross-functional teams throughout the organization. Final level will be determined commensurate with the candidate's experience and demonstrated scope of leadership. Responsibilities: Work with the CMR portfolio PM and lead Asset PM to align program planning and execution with corporate objectives and Product Development Team (PDT) strategy. Develop project scope, timelines, budgets, and resource plans across the clinical portfolio. Lead cross-functional study team and governance meetings, including agendas, decision logs, minutes, action-item tracking, collaboration, and team alignment. Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory leaders to develop and maintain project plans, timelines, and dashboards for multiple clinical programs aligned with department and corporate objectives. Identify, score, and communicate risks through maintained risk registers with proactive mitigation and contingency plans; ensure department timelines and risk trackers integrate with the corporate portfolio and integrated roadmaps. Manage CROs, vendors, and external partners by tracking performance and contracts, escalating and resolving issues, leading vendor governance meetings, and cultivating durable relationships focused on on-time, quality delivery. Support preparation and submission of regulatory filings, including INDs and BLAs, in partnership with Clinical, Regulatory Affairs, Technical Development, and Supply Chain. Prepare and present project updates to senior management and key stakeholders to support decision-making; partner with Finance and Legal to facilitate on-time, on-budget milestone delivery. Advance enterprise PMO best practices by creating and using PM tools and templates that support continuous improvement and scalable processes. Serve as Smartsheet Super User by building and publishing project and portfolio-level plans, dashboards, and reports, and training team members on Smartsheet functionality. Work across time zones as necessary; travel 10-15% may be required; other duties as assigned. Qualifications: