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, risks, dependencies, and key decisions into unified program plans. In partnership with Enterprise Program Management, the role establishes Clinical Development & Operations governance and ensures cross-functional risks, dependencies, and decision requests are appropriately elevated through enterprise governance to support informed decision-making and coordinated execution.
Roles and Responsibilities
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.
Qualifications
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.
Familiarity with procurement, contract, and financial management systems (e.g., Coupa, iValua, SAP, Ariba, or equivalent).
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
