Director, Product Development

Personal Genome Diagnostics (PGD)   •  

Baltimore, MD

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 76 days ago

This job is no longer available.



Personal Genome Diagnostics (PGDx) is seeking an extraordinary, highly motivated individual to join our research and development team, with a focus on tissue and cell-free DNA liquid biopsy approaches. The successful candidate will lead the development and optimization of cutting-edge diagnostic technologies for use as an IVD. Candidate should have a background in developing Class II or Class III assays, with design control and product development process experience.


The main responsibilities of the Director, Product Development are to provide management and leadership to a late stage product development team to ensure project objectives and delivery are met.

  • Leads late-stage product development team developing and launching new products to drive business growth strategy and meet customer needs with a focus on tissue and cell-free DNA liquid biopsy assays
  • Guides and oversees project teams to proceed through verification, validation, FDA 510K and PMA submissions, and product launch withsound planning, risk management and persistent execution to achieve program objectives
  • Develops, guides, and oversees design transfer process to ensure successful scale-up manufacture and transfer process to achieve program objectives
  • Builds successful product development team with Development Leaders, Team Leads, Scientists and Genome Research Technologists fulfilling the resource requirements to execute on projects in the product pipeline
  • Aligns resources, seeks the input of key stakeholders, and manages the team performance to achieve desired results
  • Collaborates cross-functionally to develop efficient processes for product development as the company’s product portfolio grows
  • Recognizes the gaps, initiates, develops and establishes infrastructure, tools and knowledge base to propel successful product developments
  • Owns content and ensures best practices for design control documentation, technical protocols, data and analysis
  • Continually evaluates and improves product development processes
  • Develops technical experience in pre-analytical sample preparation, library preparation, sequencing, data analysis and bioinformatics
  • Implements and ensures strict adherence to quality control and quality assurance measures of NGS assays
  • Ensures adherence to all regulatory guidelines, company policies, and SOPs
  • Develops cross-functional plan for product launch with regulatory, marketing, and manufacturing groups
  • Provides technical input and expertise to research and early development R&D teams for successful late-stage product development
  • Provides technical input and expertise to cross-functional groups for successful late-stage product development
  • Serves as technical and development process expert to represent pharma for CDx discussions and delivery
  • Maintains broad knowledge of state-of-the-art principles and theory
  • Makes important contributions to scientific literature and conferences
  • Exhibits an exceptional degree of sustained ingenuity, creativity and resourcefulness
  • Applies and/or develops highly advanced technologies, scientific principles, theories and concepts that may be new to the industry
  • Helps establish procedures for maintaining standards and consistency in operations
  • Promotes quality and procedural improvement thought process


  • Ph.D. Degree in related field with a minimum of 6-8+ years’ experience OR Master’s Degree with minimum of 10+ years of product development and leadership experience in molecular diagnostics or medical device industry
  • Experience in 510k, PMA submissions, and FDA interactions required
  • Design control expertise required
  • Expert knowledge of scientific principles and concepts
  • Oncology and/or diagnostics experience strongly preferred
  • Experience with next-generation sequencing technology and bioinformatics analyses of cancer strongly preferred
  • Experience supervising or managing research teams