Principal Program Manager

Kymanox•King of Prussia, PA

24d•Hybrid

About The Position

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. 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.

Requirements

Minimum bachelor's degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution.
10+ years in the biopharma and/or medical device industries, including 7+ years working directly on drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors, on-body injectors, infusion pumps, nasal sprays, inhalers).
7+ years of project or program management, including at least 3 years as the accountable lead for cross-functional device or combination product development programs.
3+ years mentoring and leading others, formally or informally, including reviewing technical work, providing constructive feedback, and coaching or oversight of professional development initiatives.
Demonstrated leadership in at least one of the following technical subject matters: Early-phase design and innovation: leading concept-through-design-freeze work, including user needs, design inputs, device selection, feasibility assessment, and design reviews. OR Design Verification and Device Testing Management: planning and managing design verification programs, test method development and validation, testing protocol and report authorship, traceability matrices, and DHF compilation or remediation.
Working knowledge of combination product and design control requirements. This includes 21 CFR Part 4, FDA’s Quality Management System Regulation (21 CFR Park 820 / ISO 13485), ISO 14971, and relevant device standards such as ISO 11608 and ISO 11040.
Versatile and adaptable technical skills
Able to execute high-profile activities with minimal supervision, manages time wisely and delegates as necessary
Positive attitude, and welcomes new challenges
Flexible to be present at client sites and sometimes travel
Strong professional presence and presentation skills
Extremely detail-orientated and highly organized
Excellent written and oral English communication skills
Comfortable providing feedback and influencing internal and external stakeholders
Emotionally stable and can navigate challenging clients and situations
Seasoned soft skills – high EQ and team player
Ability to work effectively with remote team members
Tackle problems proactively
A mindset of innovation and creativity
Proficient in hands-on lab operations and competent in GLP/ GDP
Computer and IT savvy
Thrive in a fast-paced, growing, and dynamic work environment
Expertly solicit and utilize subject matter expert input
Value and understand quality
Uncompromised honesty and integrity

Nice To Haves

Consulting or client-facing experience is preferred.
PMP certification is preferred.
Direct people management experience is preferred.
Significant contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or medical device/electromechanical systems development is desirable.
Industry certificates in project management (e.g., PMP), six-sigma, quality, or regulatory affairs preferred but not required.

Responsibilities

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.
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.
Mentor junior and mid-level program managers and engineers and review their work before client delivery.
Coach and develop team members, with the expectation of taking on direct reports as the PMO grows.
Oversee team capacity and project assignments in partnership with PMO leadership.
Develop project management best practices and drive their adoption across the company.
Collaborate cross-functionally within Kymanox and with client organizations.
Uphold regulatory standards and model a positive compliance culture.