Managing Principal, Project Management

Primary Function of Position:

The Managing Principal Project Management Clinical Affairs plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization including R&D Regulatory Affairs (RA) Clinical Development Engineering Quality and Business Unit PMOs. This role brings disciplined structure cross-functional coordination and strategic oversight to high-priority clinical affairs initiatives. Responsibilities include providing project management support and cross-functional coordinationwithin Clinical Affairs and with enterprise stakeholdersthrough the planning and execution of clinical studies (e.g. FHUs and IDE studies) and coordinating Clinical Evaluations to support MDR and other global  submissions. The role is accountable for building and sustaining effective collaboration across stakeholders to ensure Clinical Affairs deliverables are completed successfully and on time.

The Managing Principal Project Management leads the project manager embedded within Clinical Affairs and works cross-functionally with R&D Regulatory Affairs Clinical Development Engineering Quality and Business Unit PMOs to align strategic objectives with program execution. This leader is accountable for developing robust project plans managing risks and budgets and providing portfolio-level visibility to executive leadership ensuring that Clinical Affairs deliverables and sustaining programs are completed successfully on time and within scope.

An ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans including development roadmaps governance forums prioritization and alignment with business units and other key stakeholders. The role also requires hands-on management of project risks troubleshooting execution challenges coordinating internal and external activities and ensuring milestones are achieved on time and within scope. Examples include developing bottom-up schedules identifying critical path activities maintaining risk registers and leading detailed project reviews to drive continuous improvement.

Additionally this role supports development of Clinical Affairs tools and operating mechanisms including project dashboards capacity and resource planning and other processes needed to improve visibility planning and execution across the function.

Roles and Responsibilities:

Strategic Leadership & Vision

• Provides an inspiring vision that fosters an environment that encourages creativity disciplined risk-taking and crisp execution.
• Directs activities of project managers responsible for clinical affairs programs sustaining portfolio projects and regulatory submission timelines.
• Collaborates with Business PMO leadership to drive key process initiatives that enhance effectiveness in NPD process governance resource planning and portfolio management.
• Leads the review board for sustaining and clinical affairs projects within the BU portfolio ensuring alignment to business objectives and effective decision-making.

Clinical Affairs Program Management

• Oversees project planning and initiation of Clinical Affairs activities across clinical studies (e.g. FHUs IDE studies) and clinical dossier deliverables (e.g. EU Clinical Evaluation Reports) ensuring alignment to program milestones and regulatory expectations.
• Directs the development and maintenance of integrated project plans that define scope timelines dependencies resourcing and deliverables for key Clinical Affairs workstreams.
• Provides strategic oversight for coordination within Clinical Affairs subfunctions including Clinical Operations Clinical Data Management Biostatistics and Medical Sciences to ensure timely and consistent execution of study and submission deliverables.
• Drives alignment between Clinical Affairs programs and the broader product development lifecycle partnering with R&D Regulatory and Business Units to manage cross-functional dependencies.

Portfolio Execution & Risk Management

• Leverages PMI best practices frameworks and industry tools to improve project planning risk mitigation execution and value delivery across clinical and sustaining portfolios.
• Proactively manages changes in project scope identifying impact tradeoffs and associated contingency plans.
• Drives escalations to close major gaps; balances competing priorities through resource leveling and appropriate tradeoffs.
• Estimates and identifies resource capacity and capabilities needed to achieve project goals through established resource planning models and tools.
• Manages third-party vendors for project resources as needed; negotiates and obtains project statements of work quotes and contracts.

Governance & Stakeholder Communication

• Provides regular portfolio updates to executive leadership and actively communicates status on key milestones through dashboards and metrics (RAG status milestone summaries KPIs).
• Interacts internally and externally with executive-level management requiring negotiation of critical matters.
• Facilitates governance forums and working sessions by setting agendas capturing decisions and driving alignment across functions and business units.
• Manages escalation pathways by surfacing critical issues early aligning recommended options and coordinating timely resolution.
• Serves as a senior liaison between Clinical Affairs and key collaborative functions including cross-functional working groups to drive alignment and resolve conflicts.

Process Improvement & Standardization

• Standardizes project management levels of service frameworks tools and key performance indicators to enable project success across clinical and sustaining programs.
• Leads key PMO initiatives and process improvements to increase R&D and Clinical Affairs productivity scalability and efficiency.
• Drives development of Clinical Affairs operating mechanisms including project dashboards capacity and resource planning and other processes needed to improve visibility and execution across the function.
• Oversees development of project documentation including project charters project plans RFPs process maps and business requirements.
• Develops tracks and reports project cost and spending on a periodic basis.

Qualifications :

Skill/Job Requirements:

Required Skills and Experience

• Minimum 10 years of experience in the medical device industry or a highly regulated environment.
• Minimum 4 years of leadership and team management experience.
• Minimum 3 years of experience focused on clinical project management including clinical studies and/or regulatory submissions in a medical device context.
• Deep familiarity with all stages of clinical studies design control processes and the product development lifecycle.
• Strong understanding of clinical research regulations and global regulatory standards applicable to medical devices (FDA EU MDR ISO 14155 ICH GCP).
• Proficiency with Project Management industry standards techniques tools and methodologies (PMP preferred).
• Proficiency with project management tools such as Smartsheet MS Project or equivalent.
• Proven ability to lead influence and collaborate cross-functionally to achieve shared goals.
• Strong negotiation influencing and change management skills to coalesce conflicting views and drive alignment.
• Excellent communication (written and verbal) skills and executive presence.
• Strong people management skills with the ability to ensure team success.

Required Education and Training

• Minimum: Bachelors degree in Life Sciences Engineering or a related field.
• Preferred: Masters degree (MS/MBA).
• PMP Certification strongly preferred.

Preferred Skills and Experience

• Proven track record of successful cross-functional program leadership in a regulated clinical or medical device environment.
• Experience acting as a liaison between clinical affairs and technical/project management teams.
• Experience with regulatory submissions including IDE studies FHUs and EU MDR Clinical Evaluation Reports (CERs).
• Demonstrated ability to build and scale PMO operating models within a clinical or R&D organization.

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