Managing Principal, Project Management

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 productivit