about 1 month ago
VP, Clinical Development
Location: San Francisco, CA
Type: Full Time Permanent
A leading company in the biosimilars space focused on therapeutics in Oncology, anti-tnf, and ophthalmology and metabolic is looking to hire a new VP, Clinical Development - Oncology. They already have one commercialized product on the market and are looking to file at least 2 more BLAs in 2021. Reporting to the CMO, the Vice President will provide Medical leadership and oversight of the Coherus Oncology clinical programs, oversee safety for clinical studies, and review and interpret clinical trial data.
- Continue the clinical development activities of our oncology products in order to obtain successful regulatory submissions
- Write study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
- Oversee medical monitoring and safety for clinical studies
- Review and interpret clinical trial data
- Contribute to and review of scientific publications
- Represent clinical research on internal program teams and external project teams
- Participate in discussions with regulatory authorities as appropriate
- M.D. required
- Oncology clinical experience and drug development experience a must
- 7+ years of experience in a clinical research role in the biopharmaceutical industry
- Management experience required
- Proven track record in late stage development and regulatory filing.
- Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process
- Prior experience working in a small/emerging company is strongly preferred
I am a Clinical Development market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at email@example.com