Associate Director, Strategic Program Management

Associate Director, Strategic Program Management

We are seeking an experienced Associate Director of Project Management to join our PMO and lead high-complexity programs across our In Vitro Diagnostics (IVD) portfolio. This individual will simultaneously manage multiple large-scale projects and serve as a primary point of contact for pharma and biotech partners. The ideal candidate brings deep IVD domain expertise, a strong regulatory background including PMA submissions, and the leadership presence to drive cross-functional alignment independently and at pace.

This role requires someone who commands their programs, knowing every critical milestone, dependency, and risk from memory, proactively surfacing issues before they escalate, and leading stakeholder discussions to clear decisions without requiring manager intervention.

Key Responsibilities

• Lead and manage multiple concurrent IVD development programs from initiation through commercialization, ensuring on-time, on-budget, and on-scope delivery
• Maintain real-time command of all program milestones, dependencies, and critical dates across the portfolio, able to communicate status with confidence in any stakeholder conversation without referencing documents
• Develop and maintain integrated master project schedules, risk registers, resource plans, and executive dashboards across the portfolio
• Own the change control log and regulatory impact assessments for IVD programs independently, including verification of inputs from Lab Director, LabOps, reagent, software, and partner teams
• Serve as the primary PMO liaison for pharma and biotech partner relationships, managing joint governance, reporting cadences, and escalation paths
• Lead cross-functional meetings to clear decisions and documented action items; does not leave discussions open or defer without direction
• Independently manage stakeholder alignment discussions to closure, including resolving disagreement and ensuring clear decisions and next steps without requiring manager intervention
• Build and maintain stakeholder confidence through structured, accurate, and proactive communication at all levels
• Drive PMA submission readiness, coordinating cross-functional workstreams across R&D, Regulatory Affairs, Quality, Clinical, and Manufacturing
• Standardize and continuously improve PMO frameworks, tools, and templates aligned with IVD regulatory requirements (21 CFR Part 820, ISO 13485)
• Proactively surface risks, changes, and issues to leadership before they escalate; ensure manager has full visibility at all times
• Provide structured, substantive updates to leadership covering priorities, progress, risks, and support needed, without being prompted
• Facilitate project governance forums, steering committees, and partner-facing reviews with clear, structured communication
• Mentor and coach junior PMs within the PMO function
• Partner with Finance to manage project budgets, forecasting, and resource utilization across the portfolio

Qualifications

Required:

• 12+ years of project management experience, with at least 3 years managing IVD or medical device programs
• Direct experience supporting or leading PMA (Premarket Approval) submissions with FDA
• Proven ability to manage multiple large, complex programs simultaneously in a matrixed organization
• Experience managing pharma or biotech partner relationships, including joint project governance
• Strong understanding of IVD development lifecycle, design controls, and 21 CFR Part 820 / ISO 13485 requirements
• Exceptional stakeholder communication skills, able to present to senior leadership and external partners with confidence
• Demonstrated ability to independently lead and close stakeholder alignment discussions without manager escalation
• Track record of proactive upward communication in fast-moving, high-stakes regulatory programs
• Comfortable being "on the spot" with partners and senior leadership regarding program status, timelines, and risks
• Exceptional command of integrated project planning: dependencies, sequencing, critical path, and milestone ownership
• Proficiency with project management tools (MS Project, Smartsheet, or equivalent)

Preferred:

• PMP, PgMP, or equivalent certification
• Experience with companion diagnostics (CDx) co-development programs
• Familiarity with EU IVDR and global IVD regulatory pathways
• Background in clinical or analytical laboratory settings

Education

• Bachelor's degree in Life Sciences, Engineering, or a related field required
• Master's degree (MBA, MPH, MS) preferred