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.

DIRECTOR, PRODUCT DEVELOPMENT

JOB DESCRIPTION:

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.

KEY RESPONSIBILITIES:

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

REQUIRED EDUCATION & EXPERIENCE:

  • 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