Job Type: Full-time
Salary: $160,000 - $200,000
Location: Alameda, CA
Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells.
The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies.
Responsibilities:
- Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives.
- Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician.
- Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests.
- Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making.
- Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance.
- Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards.
- Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices.
- Providing guidance and mentorship to junior staff on best practices in clinical research and trial management.
Requirements:
- Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience.
- Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) '
- Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous)
- Regulatory submission experience is a plus.
Benefits:
- Pre-IPO stock options
- Health benefits (medical, dental, and vision)
- Competitive salary with comprehensive benefits and PTO
- 401K contribution
- Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide
