Job Type: Full-time
Salary: $250K - $300K
Location: San Francisco Bay Area
Company Summary: Clinical stage biotech developing a pipeline of first in class cell therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised over a quarter million in funding to continue advancing their clinical programs.
The Opportunity: The SD/ED, Clin Ops will play a critical role in the designing and implementing clinical trial protocols to advance their early phase cell therapy programs. Reporting to the Chief Medical Officer, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies in a timely manner.
Responsibilities:
- Reporting into the CMO
- Providing critical leadership, oversight, and line management for early-stage oncology program ensuring that clinical trials are conducted in accordance with the protocols, timelines, and budgets
- Supporting cross functional development of departmental policies
- Developing and implementing study and program budgets, including CRO/vendor budgets and contracts with a planning horizon of 1-2 years
- Management of clinical trials and operations in one or more drug development programs
- Leading site and vendor selection processes, including, the selection of Contract Research Organizations (CROs)
An ideal candidate for this role MUST have…
- 15+ years of biopharma INDUSTRY experience REQUIRED
- 8+ years of direct oncology/autoimmune trial management experience
- 5+ years of Associate Director/Director experience at a small biotech
- Demonstrated success identifying, negotiating and overseeing outsourced vendors
- A working knowledge of ICH GCP guidelines
Benefits:
- Pre-IPO biotech company
- Competitive salary with comprehensive benefits (90% medical coverage)
- Flexible PTO and WFH arrangements
- 401K contribution
- Cell phone reimbursement, life insurance, and additional perks
