The Senior Medical Director - Drug Development will lead a cross-functional clinical development research team which will include vendors, contract research organizations and consultants. The Senior Medical Director is expected to work in the Irvine offices at least 3 days a week.
Requirements for the Senior Medical Director:
- 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: 29-1229 Physicians, All Other