Associate Director PMO, Clinical Programs

Johnson & Johnson Innovative MedicineIrvine, CA
$137,000 - $235,750Onsite

About The Position

The Associate Director PMO, Clinical Programs, is accountable for enterprise integration and decision enablement across the clinical evidence portfolio. The role consolidates function-owned clinical plans into an integrated portfolio view; connects clinical milestones with product development, regulatory, supply chain, finance, and commercial priorities; and enables governance decisions through portfolio analytics, scenario planning, prioritization, and cross-functional escalation. This position owns the integrated portfolio roadmap, enterprise governance process, cross-functional dependency and readiness management, portfolio-level demand and capacity scenarios, consolidated reporting, and escalation of constraints that span multiple functions or programs. Scientific Affairs and Clinical Research retain ownership for clinical strategy, study design, operational plans, study schedules and deliverables, study-level risks and corrective actions, clinical budgets, CRO and vendor management, functional staffing, and leadership of Clinical Research Project Management personnel. The PMO role challenges, integrates, facilitates, recommends, and escalates; it does not direct study execution or create a parallel clinical delivery organization.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or related field required.
  • 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 and project planning tools (Smartsheet, Power BI, Wrike, Microsoft Project, etc.)
  • 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.
  • 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.
  • Must be willing and able to periodically travel overnight domestically and internationally up to 25%.

Nice To Haves

  • Advanced degree (MS, MPH, MBA, or PhD) preferred.

Responsibilities

  • Own the enterprise clinical portfolio roadmap by consolidating approved, function-owned study plans and forecasts into a forward-looking view aligned with product development milestones, regulatory submissions, supply readiness, regional launches, lifecycle priorities, and post-market evidence commitments. Identify cross-program sequencing, dependencies, decision points, and readiness gaps; Clinical Research retains ownership of the underlying study plans, schedules, deliverables, and execution.
  • Translate approved study plans, enrollment forecasts, site activation schedules, and portfolio priorities into time-phased demand requirements for equipment, investigational products, components, and ancillary materials. Maintain a rolling forecast with Scientific Affairs, Supply Chain, Finance, and study teams; reconcile demand with inventory, capacity, lead times, shelf life, labeling, country requirements, and budget constraints.
  • Own the enterprise clinical portfolio governance cadence and decision package using validated inputs from accountable functional leaders. Frame portfolio-level choices, challenge assumptions, model cross-functional trade-offs, document decisions and decision rights, and track enterprise actions to closure. Clinical Research and other functional leaders retain authority for decisions within their functions and for study-level execution.
  • Own the integrated view of risks, assumptions, issues, dependencies, constraints, and readiness gaps that affect multiple functions, programs, regulatory milestones, supply readiness, or launch commitments. Confirm functional ownership, facilitate coordinated resolution, and escalate unresolved portfolio-level constraints through governance. Clinical Research owns study-level risk identification, mitigation, corrective action, and operational resolution.
  • Own consolidated portfolio reporting and analytics using approved milestones, KPIs, forecasts, assumptions, and budget inputs supplied by functional owners. Analyze schedule confidence, forecast accuracy, inventory exposure, capacity constraints, and portfolio trends to recommend prioritization and scenario decisions. Clinical Research and designated budget owners retain accountability for study budgets, forecasts, reconciliation, corrective action, and study-level performance reporting.
  • Own portfolio-level demand, capacity, and scenario analyses using resource inputs supplied and approved by functional leaders. Recommend portfolio prioritization, sequencing, and mitigation options when demand exceeds capacity or enterprise milestones are at risk. Functional leaders retain decision authority for headcount, role assignments, performance management, and day-to-day deployment of their teams.
  • Serve as the central PMO coordination point across Scientific Affairs, R&D, Regulatory, Quality, Supply Chain, Commercial, Finance, regional teams, and program leadership. Build alignment around portfolio assumptions, handoffs, milestones, evidence readiness, escalation pathways, and stakeholder expectations.
  • Own and continuously improve methods for enterprise clinical portfolio integration, demand forecasting, capacity planning, scenario analysis, governance, and executive reporting. Coach program and functional partners on integrated planning, escalation quality, decision framing, and portfolio reporting. Scientific Affairs retains ownership for Clinical Research operating procedures, technical project-management practices, and the development and performance management of Clinical Research Project Managers.

Benefits

  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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