Director/Senior Director, Clinical Operations
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Renasant BioBiotechnology
Remote / Berkeley, CAFull-TimeDirector
Salary$210,000 - $270,000 a year; $210,000 - $275,000 per year (Director: $210,000 - $240,000; Senior Director: $240,000 - $275,000)
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Job Details
- Experience
- 10+ years of clinical operations experience (15+ for Senior Director)
- Required Skills
- Budget management
Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 10+ years of clinical operations experience (15+ for Senior Director).
- Proven experience leading clinical studies from startup through database lock and closeout.
- Background in rare disease, nephrology, ADPKD, or genetic disease populations.
- Experience with genetic testing or genomics-driven patient identification.
- Strong track record of managing CROs and external vendors in outsourced models.
- Demonstrated success in global site activation and study startup.
- Expertise in budget development, timeline management, and operational risk assessment.
- Comprehensive knowledge of ICH-GCP, FDA, and EMA global clinical trial regulations.
Responsibilities
- Design and implement scalable clinical operations processes, governance, and vendor oversight models.
- Establish clinical execution frameworks as the organization scales.
- Lead selection and performance management of CROs, central laboratories, and specialty vendors.
- Develop operational strategies for patient identification and enrollment in rare, genetically defined populations.
- Collaborate with research and development teams to transition programs from preclinical to clinical stages.
- Oversee end-to-end study execution from startup through database lock and closeout.
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