NateraHiring

Associate Director, Strategic Program Management

  • Remote, United States
  • Lead
  • Posted 2 days ago
In one line

Program leadership role for IVD and companion diagnostic work, taking programs from planning through PMA submission.

About the role

A cross-functional job with no direct reports, where influence and clear decisions matter more than authority. External pharma partner relationships sit with other leaders.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
IVD, CDx, PMA, Design controls, FDA, Analytical validation, Clinical validation
Posted
2 Nov 2026
Last checked
3 Nov 2026

What you will do

  • Keep one integrated plan covering deliverables, resources, dependencies, decisions and regulatory milestones
  • Set up governance, ownership, escalation routes and accountability for commitments

What they look for

  • A degree in life sciences, engineering or a similar field, or equal practical experience
  • Ten or more years of growing program or project management work in molecular diagnostics, IVD, devices, biotech or another regulated area
  • Hands-on leadership of CDx or IVD programs with design controls, validation planning and FDA submission prep
  • Track record of integrated plans spanning technical, clinical, regulatory, quality, software and operations groups

A typical week

  • Spot risks and trade-offs early, then push decisions across functions
  • Lead gate reviews that check deliverables, readiness, open risks and choices
  • Present strategy, progress and options to the executive leadership team
  • Track submission-critical evidence and close gaps that could affect PMA quality or timing

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Questions about this job

Is this job fully remote, and from where?

Yes. The posting lists Associate Director, Strategic Program Management as a remote role for candidates in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a lead role. The posting asks for: a degree in life sciences, engineering or a similar field, or equal practical experience; ten or more years of growing program or project management work in molecular diagnostics, IVD, devices, biotech or another regulated area; hands-on leadership of CDx or IVD programs with design controls, validation planning and FDA submission prep. Skills it names include IVD, CDx, PMA, Design controls.

How do I apply with Keywordise AI?

Select Apply with Keywordise AI, sign up and upload your CV. Keywordise writes a CV and a cover letter for this job from your real experience and applies for you. The 7-day free trial needs no card.

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