Salary: $155 - $185K
Location: South San Francisco, CA (Hybrid - must be local)
Company Summary: Working with a biotechnology company as they continue to develop precisely targeted immunotherapies for cancer and other diseases. With their cis-targeting platform, they hope to address limitations present in other immunotherapies. Their mission is to advance their pipeline of best-in-class immunotherapies in cancer and infectious diseases and ultimately, improve the livelihood of patients.
The Opportunity: The Clinical Scientist/Senior Clinical Scientist role contributes to the execution and interpretation of their clinical trials. This team member will provide scientific expertise to the internal team members to ensure quality processes and timely deliverables for our lead asset in Phase I clinical trials. This position will report to the Director of Clinical Sciences.
Responsibilities:
- Contributing to clinical development concepts and plans in tandem with the Director, Clinical Science
- Writing drafts of protocol synopses, protocols and protocol amendments
- Contributing to the implementation and review of clinical trial protocols for scientific and operational accuracy
- Participating in the review, analysis and reporting of clinical trial data, including drug safety surveillance activities
- Partnering with Director, Clin Sci to provide clinical summary reports and presentations of clinical data for internal and external uses
- Developing and review clinical study documents
- Updating the clinical sections of investigator brochures and leading the team that writes the subsequent annual updates
- Providing subject matter expertise, clinical science support, and functional representation on project teams
- Supporting the clinical development leadership participating in clinical/medical advisory panels, steering committees, and investigator meetings
- Training colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
- Performing therapeutic area/indication research and competitor analysis, remaining up to date on pharmaceutical guidelines, practices, and therapeutic knowledge
Requirements:
- PhD/PharmD within a clinical and/or scientific profession (or an equivalent level of professional, clinical, and/or scientific education, training and experience) required.
- 3+ years of experience in clinical trials in the ONCOLOGY clinical development space (early clin dev exp. preferred)
- Previous experience working on a clinical development program from study start up to close out
- Previous experience working in a cross functional drug development team
- Excellent analytical and writing skills, ability to describe complex issues in a simple way through written and oral communication, and ability to orchestrate plans to resolve issues and mitigate risks
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
