Clinical Program Manager

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 risks dependencies and key decisions into unified program 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 :

Qualifications

• Bachelors 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).

Additional Information :

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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time