Director, Gene Therapy CMC Program Management

Job Juncture in Philadelphia, PA

  • Industry: Healthcare - Allied Health - Respiratory Therapist
  • Type: Full Time
  • Compensation: $59,200.00 - 78,460.00 / Year*
position filled

My client is seeking a Program Management Director to oversee its pipeline of AAV gene therapy programs. The ideal candidate will take on the following tasks:

  • Plan and execute fully integrated CMC plans for developing gene therapy programs
  • Manage operations including implementing strategies, creating fully integrated development plan and timelines, and monitoring key milestones and decision points to drive delivery of program objectives
  • Develop program strategy and plans, set milestones and timelines and coordinate the cross-functional activities required for drug development
  • Build and maintain strong relationships with external partners in academia, industry and CMOs

The ideal candidate will possess the following qualities:

  • MS/PhD and 5+ years of experience the biotech field, including Phase I experience
  • Gene Therapy experience required
  • 5+ years drug development including managing multiple projects and coordinating cross-functional projects (with research, pharmacology, toxicology, manufacturing, regulatory and clinical) to achieve milestones and deliverables on schedule
  • Track record of leading and advancing projects from research into clinic including experience with IND and BLA filings
  • Experience in tech transfers, manufacturing, quality systems, CMO management, regulatory requirements, and commercial development
  • Exceptional interpersonal and communication skills to bridge scientific and business leadership and drive programs to implementation
  • PMP certification preferred

Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

* Estimated salary


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