A startup sized Oncology Biotech located in the Bay Area is looking to bring an experienced Associate Director, or Director of Clinical Operations onto its team. This company focuses on creating products and therapeutics to combat cancer and improve the lives of those living with the disease.
The Associate Director/Director of Clinical Operations will be focusing on the company's early phase Oncology program, which boasts multiple studies. They will be reporting into and working closely with the VP of Clinical Operations ensure timely and successful delivery of study deliverables.
Responsibilities include but are not limited to:
- Planning, executing, management, and oversight of Clinical Trials
- Providing strategic oversight on study timelines, budgets, deliverables
- Building a cross functional team dynamic
- Leading vendor selection/site selection processes
- Oversees creation of study budget, monitoring, recruitment, and timeline plans
- Supervise, oversee, and maintain communication with CRO and other third-party vendors
- Lead the development of study protocols, study SOPs, ICF forms, CRFs, etc.
- Lead a cross-functional team including clinical operations, data management, regulatory affairs, pharmacovigilance, biostatistics, etc.
- Execute clinical studies according to ICH/GCP guidelines, FDA regulations, from startup through closeout
- Keep stakeholders informed of and up to date with study progress/advancement
Qualifications include:
- Bachelor's degree (life sciences preferred)
- Oncology Trial Management experience in an industry setting is REQUIRED
- 12+ years clinical research experience, in an industry setting
- 8+ years Clinical Trial Management experience, in an industry setting
- An understanding of cross-functional clinical processes
- Ability to juggle multiple complex tasks at any given time
- Ability to think in terms of the bigger picture when carrying out complex clinical trials
- Experience with financial planning and foresight related to Clinical Trial programs
