Associate Director, Strategic Program Management (IVD)

TL;DR

Associate Director, Strategic Program Management (IVD): Leading high-complexity programs across the In Vitro Diagnostics portfolio with an accent on PMA submissions and pharma/biotech partnerships. Focus on driving cross-functional alignment, managing regulatory impact assessments, and ensuring on-time delivery of large-scale medical device projects.

Location: Hybrid (San Carlos, CA). Must live within a reasonable commute and be comfortable coming into the office a couple of times per month.

Salary: $166,700 - $210,000 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, specializing in personalized genetic testing and diagnostics for oncology, women's health, and organ health.

What you will do

• Manage multiple concurrent IVD development programs from initiation through commercialization.
• Develop integrated master project schedules, risk registers, and executive dashboards across the portfolio.
• Serve as the primary PMO liaison for pharma and biotech partner relationships and joint governance.
• Drive PMA submission readiness by coordinating workstreams across R&D, Regulatory, Quality, and Manufacturing.
• Standardize and improve PMO frameworks aligned with 21 CFR Part 820 and ISO 13485.
• Mentor and coach junior Project Managers within the PMO function.

Requirements

• 12+ years of project management experience, including 3+ years managing IVD or medical device programs.
• Direct experience supporting or leading PMA (Premarket Approval) submissions with the FDA.
• Strong understanding of IVD development lifecycle, design controls, and 21 CFR Part 820 / ISO 13485.
• Must be based in or near San Carlos, CA.
• Proven ability to lead stakeholder alignment discussions and resolve disagreements independently.
• Bachelor's degree in Life Sciences, Engineering, or a related field.

Nice to have

• PMP or PgMP certification.
• Experience with companion diagnostics (CDx) co-development programs.
• Familiarity with EU IVDR and global IVD regulatory pathways.
• Master's degree (MBA, MPH, MS).

Culture & Benefits

• Annual performance incentive bonus and long-term equity awards.
• Comprehensive health benefits including medical, dental, and vision.
• 401(k) with company match.
• Generous paid time off, company holidays, and wellness benefits.
• Free genetic testing for employees and their immediate families.