Clinical Program Manager

Job description

Job responsibilities

• Support the Program Management & Operations team in creating and implementing Clinical Development & Operations governance processes, including governance forums, operating cadences, decision pathways, program…
• Facilitate Clinical Development & Operations & Operations governance by preparing governance materials, maintaining clinical RAID and decision logs, capturing actions and decisions, monitoring follow-through, and…
• Develop, maintain, and communicate integrated timelines across the clinical portfolio, ensuring alignment of milestones, dependencies, critical path activities, and cross-functional deliverables.
• Coordinate program-level execution across Study Leads, Clinical Operations, Data Management, Biostatistics, Safety, Regulatory Affairs, Medical Writing, Quality, and external partners, providing hands-on project…
• Monitor portfolio execution, proactively identifying schedule impacts, resource constraints, cross-study dependencies, and operational risks, and facilitate development of mitigation plans.
• Develop executive-ready portfolio reporting that communicates program health, milestone performance, critical path status, key risks, decision requests, and recommended actions.
• Identify portfolio trends and opportunities to strengthen planning, governance, reporting, and operational effectiveness across Clinical Development & Operations.
• Support regular functional-area budget management in coordination with Clinical Development & Operations Functional Area Team Leads and PM&O by tracking actual and forecasted accruals, invoices, purchase orders, and…

Job requirements

• Bachelor's degree in Pharma/Life Sciences, or a related field (or equivalent experience). An advanced degree is preferred.
• Minimum 10 years of program or project management experience in pharmaceutical, biotechnology, medical device, or CRO industry supporting Clinical Development & Operations through NDA regulatory submissions.
• Demonstrated success leading cross-functional planning and execution across multiple concurrent clinical studies, including integrated planning, critical path management, and dependency management.
• Experience partnering with Clinical Development & Operations, CMC, Regulatory Affairs, and Quality leadership to support governance, portfolio planning, and executive decision-making.
• Experience supporting late-stage Clinical Development & Operations programs and familiarity with Clinical Development & Operations processes from start-up through close-out.
• Expertise in integrated timeline management, risk and issue management, resource coordination, and cross-functional execution.
• Strong executive communication and presentation skills, with the ability to deliver clear, actionable recommendations to senior leadership;
• Proficiency with Smartsheet, including integrated project planning, dashboards, reporting, and workflow automation.