Sr. Director Clinical Development

  • Irvine, CA
  • Direct Hire
  • Job ID: CA129-2694964
Rapidly growing biopharmaceutical company seeks a Sr. Director of Clinical Development to manage clinical development programs and supportive clinical trials of gene therapy products. The Sr. Director of Clinical Development will lead a cross-functional clinical development research team which will include vendors, contract research organizations and consultants.  
  • Bachelor’s Degree in biological sciences.
  • MD, PhD, or PharmD required.
  • 5+ years of experience in clinical development strategy development including: Phase 1 - Phase 3 trials, proof of concept trial, leading teams of biostatisticians and clinical operations through the critical milestones at the end of Phase 2.
  • 2+ years experience in early stage clinical trials with gene therapy products or biologics greatly preferred.
  • Experience managing the development program's clinical  and scientific content, timelines, and budgets.  
  • Excellent organizational and communications skills with a track record of accomplishment managing clinical trials development.
  • Strong leadership skills
  • Good presentation skills, including presentations to senior management and external audiences and experts
  • Ability to work across locations and time zones
  • The ability to manager multiple competing projects
  • Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
  • The ability to travel, including international travel, approximately 20-30%
  • Lead the cross-functional clinical development team including, vendors, contract research organizations and consultants, meeting timelines and budget.
  • Working with consultants and vendors, develop clinical trial protocol,  clinical sections of Investigator brochures, clinical study reports, presentations, briefing documents and submissions.
  • Assist in business development activities and due diligences.
  • Working with study's project manager, prepare and update timelines and budgets of the clinical development program. 
  • Assist in internal process improvement activities such as SOPs or guidance documents, as required

Occupational Category: 19-1040  Medical Scientists


Apply Online
Job Alerts

Login to create notifications on the jobs you’re looking for!

Have any questions?

Let’s get in touch

  • Upload Resume
  • Max. file size: 300 MB.
  • "If you would like immediate nation-wide exposure to several thousand recruiters within our recruiter network please upload resume here and start your job search."
    Click here
  • This field is for validation purposes and should be left unchanged.

Share on popular social media

Related Jobs

Share our job with others