Associate Director, Strategic Program Management

📋 Description

• Lead multiple concurrent IVD development programs from initiation to commercialization
• Maintain real-time milestones, dependencies, and critical dates across the portfolio
• Develop integrated master schedules, risk registers, resource plans, and exec dashboards
• Own the change control log and regulatory impact assessments for IVD programs
• PMO liaison for pharma/biotech partner relationships and governance
• Lead cross-functional meetings to clear decisions and actions

🎯 Requirements

• 12+ years of PM experience, with 3+ years on IVD/medical device programs
• Direct experience supporting/leading FDA PMA submissions
• Proven ability to manage multiple large, complex programs in a matrixed organization
• Experience managing pharma/biotech partner relationships and joint governance
• Strong understanding of IVD lifecycle, design controls, 21 CFR Part 820 / ISO 13485
• Proficiency with PM tools (MS Project, Smartsheet, or equivalent)

🎁 Benefits

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits