Director Clinical Operations
Director, Clinical Operations
California - Remote
$$2100,000 - $260,000
An emerging biotech company in LA is seeking a Director of Clinical Operations to lead programs in hair loss. The company is advancing a novel therapeutic platform focused on cell regulation, with applications across indications in alopecia and other rare diseases.
This role will be responsible for overseeing clinical trial execution from start-up through completion, including vendor and CRO management, cross-functional coordination, and operational strategy. The ideal candidate will bring strong leadership in trial design, site engagement, and regulatory compliance, along with a hands-on approach to building clinical infrastructure in a fast-paced, science-driven environment.
Key Responsibilities:
- Lead execution of Phase 1 and 2 trials, including investigator-initiated studies
- Collaborate on protocol development and trial design
- Manage CROs, vendors, and external partners
- Coordinate across clinical science, regulatory, biostats, and other functions
- Oversee drug supply logistics and biospecimen management
- Develop and implement enrollment strategies and patient-facing materials
- Ensure GCP/ICH compliance and clinical quality systems
- Support safety monitoring and pharmacovigilance activities
- Manage study budgets, site payments, and financial tracking
- Serve as primary liaison for clinical sites and oversee site performance
- Contribute to data integrity, interim analyses, and reporting
Qualifications:
- Bachelor's or Master's in life sciences or related field
- 8+ years in clinical operations with experience leading trials end-to-end
- Strong understanding of global clinical development and regulatory standards
- Proven experience managing CROs and clinical vendors
- Skilled in budgeting, forecasting, and site payment systems
- Excellent communication and problem-solving skills
- Experience in cell-based therapies, dermatology, or rare disease is a plus
- Willingness to travel as needed for site oversight