Vice President of Product Development
 Position Responsibilities:
  • Develop company’s oncology portfolio based on the nanotechnology platform through research and understanding of global oncology product market
  • Establish product plan and strategy, lead technical team to develop product roadmap for novel therapeutics
  • Define and monitor key project milestones and critical market assumptions
  • Oversee nanoformulation development, process scale up, and technology transfer from R&D to GMP manufacturing
  • Influence present and future products by determining and evaluating current and future market trends/needs in oncology
  • Maintain research database of relevant clinical oncology trials and therapeutic candidates
  • Enable non-GLP/GLP/GMP production of product
  • Establish cGMP compliant QC labs which includes evaluating and purchasing analytical instruments, and setting up processes for analytical testing and release of raw materials, in-process materials and final drug substance and drug products
  • Ensure product development is in accordance all aspects of global regulatory and quality compliance
  • Assist in regulatory filings of IND/NDA/MAA submissions

Position Requirements:
  • 10+ years of experience in oncological product development
  • 4+ years in a leadership position
  • Familiarity with regulatory requirements for IND, NDA/BLA, and MAA submissions
  • Master’s or PhD in engineering (biomedical, chemical, electrical, mechanical) or science (pharmaceutical, chemistry, molecular biology, cell biology, etc.) or an equivalent major
  • Excellent written and oral communication skills
  • Self-motivated creative problem solver that can deal with ambiguity and declare a path forwards to achieve results.
  • Ability to lead in a small, fast-paced, and perpetually evolving environment
  • Strong communication and interpersonal skills

Experience:
  • Prior experience in pharmaceutical product development focusing on sterile parenteral products
  • Working knowledge of global registration requirements and ICH guidelines for drug products including experience with IND, NDA/BLA, MAA submissions
  • Strong knowledge of global regulatory and quality compliance requirements (cGxP)
  • Previous experience working with CDER, OHOP
  • Background knowledge and technical skills in nanotechnology and nanoparticle fabrication and testing is a plus
  • Well-developed interpersonal, organization, and communication skills with the ability to work effectively with staff members at all levels


Please submit a resume/CV to [email protected] if interested.​​