Job Description

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 coordination-within Clinical Affairs and with enterprise stakeholders-through 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: Bachelor's degree in Life Sciences, Engineering, or a related field.
• Preferred: Master's 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.

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.