Sr. Manager, Clinical Programs - PMO (Irvine, CA) Johnson and Johnson, MedTech Electrophysiology

Role Summary

Johnson & Johnson MedTech Electrophysiology is recruiting for a Clinical Research, Manager, to support the Electrophysiology (EP) business unit based in Irvine, CA. The Senior Clinical Program Manager (CPM) within the PMO leads the strategic coordination, prioritization, and portfolio management of all clinical programs. This role ensures clinical activities are aligned with product development, regulatory strategy, and commercial launch timelines, while maintaining visibility and accountability across the full clinical evidence portfolio.

Responsibilities

• Lead portfolio-level planning, prioritization, and tracking of all clinical studies supporting new product development, lifecycle management, and post-market evidence.
• Manage the clinical roadmap in alignment with R&D development milestones, regulatory submissions, and commercial launch timelines.
• Ensure visibility of interdependencies across programs, including clinical, technical, and operational linkages.
• Partner with Scientific Affairs to maintain a consolidated, forward-looking portfolio view of study status, timelines, and budget allocations.
• Serve as the central point of coordination between Scientific Affairs, R&D, Regulatory, Supply Chain, and Commercial teams, driving alignment and stakeholder satisfaction.
• Ensure clinical program plans align with product development schedules and launch strategies.
• Collaborate with Supply Chain to ensure clinical and launch readiness, including product availability, labeling, and logistics for study or launch execution.
• Partner with Commercial teams to align clinical evidence generation with market access, messaging, and customer needs.
• Lead portfolio review meetings and contribute to PMO and executive steering governance.
• Maintain portfolio dashboards, KPIs, and risk registers for leadership visibility.
• Drive scenario planning and prioritization based on resource capacity, regulatory milestones, and market drivers.
• Ensure on-time readiness of clinical evidence for regulatory and commercial milestones.
• Ensure adherence to PMO governance standards, processes, and documentation practices.
• Identify and manage cross-program risks, resource optimization, constraints, and dependencies across the clinical and product lifecycle.
• Work closely with functional leaders to resolve resourcing or sequencing conflicts.
• Proactively escalate bottlenecks or misalignments that could impact evidence generation or launch readiness.
• Contribute to the refinement of PMO methodologies for clinical portfolio management.
• Support implementation of best practices in forecasting, capacity planning, and performance reporting.
• Enable a culture of proactive portfolio management and data-driven decision-making.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field required.
• Advanced degree (MS, MPH, MBA, or PhD) preferred.
• 10+ years of experience in clinical program or portfolio management within MedTech, medical devices, diagnostics, or life sciences.
• Strong understanding of clinical study design, regulatory pathways, and product development processes.
• Demonstrated success managing cross-functional clinical portfolios tied to product launches or lifecycle management.
• Experience collaborating with R&D, Supply Chain, and Commercial functions on readiness and launch coordination.
• Familiarity with PMO governance and portfolio management frameworks.
• Proficient in portfolio planning tools (e.g., Smartsheet, Clarity, Planview, Power BI).
• Solid understanding of product development lifecycles and evidence requirements for market access.
• Strong analytical, prioritization, and resource management skills.
• Skilled communicator who can engage technical and business audiences with clarity and influence.

Knowledge, Skills, Abilities And Certifications/Licenses

• PMP, PgMP, or MSP certification preferred.
• Lean Six Sigma or Agile certification a plus.
• Strategic integrator - Sees interconnections across programs and functions.
• Strong portfolio mindset - Prioritizes based on value, risk, and readiness.
• Influential communicator - Bridges clinical, technical, and commercial domains.
• Data-driven decision-maker - Leverages metrics and insights to guide trade-offs.
• Collaborative leader - Drives alignment and accountability across teams.

Additional Requirements

• Must be willing and able to periodically travel overnight locally, regionally, and nationally up to 25%.

Education

• Not specified beyond qualifications list