Salary: $145-165K
Company Summary: One of the best funded pre-IPO biotechs with upwards of half a billion in funding is growing their clinical operations team as they continue to expand their oncology trials on a global scale. With an office in Hayward, they have Nobel prize winning science and experienced former Big Pharma C-suites executives at the helm to back it. Their pipeline has 7 programs in development across 12 indications and their lead candidate is heading into Phase 3. The best fit for this role will be a team leader who has APAC trial management experience and the ability to communicate in a language relevant to the region (Korean or Japanese).
***** Candidate must be able to go on-site in Hayward, CA three times a week.****
The Clinical Program Lead will be responsible for
- Reporting into the Sr. Director or Director of Clinical Operations and working in collaboration with Clinical Ops and Clinical R&D teams.
- Leading and managing Clinical Ops Study Management team and providing direction to cross-functional study teams to ensure successful study execution.
- Ensuring the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies are conducted in accordance with applicable regulations, ICH/GCP, APAC, PMDA, regulations and Standard Operating Procedures (SOPs).
- Managing ancillary (non CRO) vendor relationships and performance.
- Providing updates on study to internal stakeholders.
- Ensuring accurate and complete filing within clinical/reg/finance/safety systems.
- Complying with internal processes, SOPs, clinical & insurance supply management, and import/export requirements.
A candidate for this role MUST have…
- Working fluency in Korean or Japanese and English
- 8+ years of experience establishing a clinical program and/or managing clinical trials in APAC region
- 5+ years of sponsor experience
- 3+ years of recent oncology or immunology experience
- 2+ of experience managing direct reports
- PhD, Master's Degree, or a Bachelor's Degree in life sciences, healthcare, or related field preferred.
Benefits:
- Working with a world class leadership team including a former CMO responsible for a blockbuster dru
- Nobel Prize winning science
- Generous PTO and holiday policies PLUS one-week summer and winter shutdowns
- Daily subsidized lunch program when on site
- 401K + stock
- Medical, Dental, & Vision
- and more!
If you are interested in this Clinical Program Manager role, feel free to reach out!
