Public listing

Life Science - Principal Program Manager

Kymanox King of Prussia, Pennsylvania
  • ListedPosted 9 days ago
  • SourceJobvite

Role overview

About the role

Description supplied by the original job listing.

Job Description:
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
The Kymanox Program Management Office is seeking a Principal Program Manager with a strong technical and/or operations background in the pharmaceutical, biotechnology, or medical device industries. Ideal candidates will build on their proven past performance supporting complex product development or life cycle management programs involving drug-device combination products.
This position is hybrid with an average of 3+ days of week at the Kymanox office in King of Prussia, PA.
Job Description:
The Principal Program Manager is the client-facing lead for a portfolio of two to five projects or one to two programs focused on drug-device combination products, and is accountable for their execution and success. The role combines program leadership with hands-on technical direction. It focuses on early-phase device design and innovation and/or on design verification (DV) and testing strategy supporting combination product Design History Files (DHFs). The Principal Program Manager also mentors and develops junior and mid-level staff and is expected to grow into direct people management within the PMO. Work may take place at client sites, at a Kymanox office, or remotely.
Program Leadership and Delivery
Serve as the primary point of contact and accountable lead for multiple client projects or programs.
Develop project plans, schedules, and overall program strategy, then drive execution to deliver on scope, schedule, and budget.
Lead core project management activities, including stakeholder and risk management, schedules, dashboards, budget tracking, meeting minutes, and client correspondence.
Build fit-for-purpose project management tools where standard tools fall short.
Delegate work to internal and external teams and monitor deliverable quality and progress.
Combination Product Technical Leadership
Act as technical lead on smaller programs or lead technical workstreams on larger programs, as needed.
Guide early-phase device development, including user needs, design inputs, device and technology selection, feasibility work, and design reviews through design freeze.
Plan and oversee DV programs, including test strategy, test method development and validation, protocol and report review, and traceability from requirements to verification evidence.
Author, review, and remediate DHF content and other technical documentation with minimal oversight.
Assess client documentation and development strategies, and deliver clear, actionable recommendations for mitigating gaps.
People Leadership and Development
Mentor junior and mid-level program managers and engineers and review their work before client delivery.
Coach and develop team members, with the expec

Skills
Project Management, Risk Management, Documentation

Skills from the listing

  • Project Management
  • Risk Management
  • Documentation

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