Primary Function of Position:
The Senior Clinical Program Manager serves as the strategic and operational partner to Clinical Development & Operations leadership, providing integrated program management across the Clinical Development & Operations portfolio from study startup through regulatory submission. The role partners with Clinical Development & Operations leadership to inform Clinical Development & Operations strategy through integrated planning, scenario analysis, governance, and execution insights, translating strategic direction into coordinated cross-functional plans that enable successful program execution.
Reporting to the Program Management & Operations organization, the Senior Clinical Program Manager partners across Clinical Development & Operations, Regulatory Affairs, Medical Affairs, CMC, Nonclinical, Quality, Commercial, and external partners to integrate timelines,…
What you'd do
- Support the Program Management & Operations team in creating and implementing Clinical Development & Operations governance processes, including governance forums, operating cadences, decision pathways, program reporting, and the RAID framework.
- Facilitate Clinical Development & Operations & Operations governance by preparing governance materials, maintaining clinical RAID and decision logs, capturing actions and decisions, monitoring follow-through, and escalating cross-functional risks and decision requests through enterprise governance, as appropriate.
- 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 management support to individual studies as needed.
- 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 inputs to the Annual Operations Budget Planning Cycle.
- Support CRO and Vendor oversight by: incorporating vendor updates into project plans and governance materials; maintaining visibility and supporting management of purchase orders, change orders, invoices, key contract terms, and performance commitments; and coordinating business reviews and operational follow-up across internal functions.
- Drive adoption of standardized project management tools, templates, dashboards, reporting practices, and workflow automation that improve portfolio visibility, consistency, and execution.
What they want
- 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; High emotional intelligence and the ability to build trusted partnerships across technical and business functions.
- Proficiency with Smartsheet, including integrated project planning, dashboards, reporting, and workflow automation.Preferred Qualifications
- Experience working with CROs, vendors, and cross-functional development teams
- PMP or comparable project management certification.
About Intuitive Surgical · General Business
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and…