Associate Director, Clinical Trial Management
Annexon Biosciences
August 19, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Associate Director of Clinical Trial Management
Responsibilities:
- Provide leadership to staff and study teams to ensure clinical trials are conducted per protocols, SOPs, Good Clinical Practices (GCP), and applicable regulatory requirements
- Accountable for oversight and execution of multiple clinical trials, including: oversight of vendor budgets and contracts; tracking/reporting study metrics; identifying/mitigating risks to study implementation, enrollment, conduct, compliance, and completion
- Develop and manage working relationships with Investigators and key clinical opinion leaders
- Provide technical expertise for clinical documents (protocols, monitoring plans, clinical trial reports, investigator brochures) and trial conduct
- Stay current on therapeutic areas, industry practices/trends, and FDA requirements; apply knowledge to current programs
- Partner with and maintain regular contact with stakeholders (Regulatory, Clinical Development, Legal, Finance, as necessary)
- Lead CRO selection for large and small budgets
- Attend CRO/vendor meetings (e.g., project kick-off, investigator meetings, quarterly meetings) to ensure alignment and achievement of study goals
- Contribute to definition, development, and implementation of Clinical Operations initiatives/best practices
- Travel may be required up to 30%
Required qualifications/skills:
- BS/BA (or equivalent experience)
- 10+ years leading clinical trial operations; multinational/multisite experience; experience in ophthalmology, neurology, rare diseases, and overall drug development; hands-on leadership and direct line-management
- Thorough knowledge of clinical development process and regulatory requirements (FDA, EMA, ICH, GCP)
- Demonstrated success identifying, negotiating, and overseeing outsourced clinical operations services/vendors
- Experience with financial budgeting/reporting
- Ability to interact with investigators, vendors, and all organizational levels
Benefits:
- Flexible work schedules; remote opportunities; work-life balance
- Shuttle service from BART, CalTrain, and the Ferry
- Base salary, equity participation, employee stock purchase plan, and comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits)
Responsibilities:
- Provide leadership to staff and study teams to ensure clinical trials are conducted per protocols, SOPs, Good Clinical Practices (GCP), and applicable regulatory requirements
- Accountable for oversight and execution of multiple clinical trials, including: oversight of vendor budgets and contracts; tracking/reporting study metrics; identifying/mitigating risks to study implementation, enrollment, conduct, compliance, and completion
- Develop and manage working relationships with Investigators and key clinical opinion leaders
- Provide technical expertise for clinical documents (protocols, monitoring plans, clinical trial reports, investigator brochures) and trial conduct
- Stay current on therapeutic areas, industry practices/trends, and FDA requirements; apply knowledge to current programs
- Partner with and maintain regular contact with stakeholders (Regulatory, Clinical Development, Legal, Finance, as necessary)
- Lead CRO selection for large and small budgets
- Attend CRO/vendor meetings (e.g., project kick-off, investigator meetings, quarterly meetings) to ensure alignment and achievement of study goals
- Contribute to definition, development, and implementation of Clinical Operations initiatives/best practices
- Travel may be required up to 30%
Required qualifications/skills:
- BS/BA (or equivalent experience)
- 10+ years leading clinical trial operations; multinational/multisite experience; experience in ophthalmology, neurology, rare diseases, and overall drug development; hands-on leadership and direct line-management
- Thorough knowledge of clinical development process and regulatory requirements (FDA, EMA, ICH, GCP)
- Demonstrated success identifying, negotiating, and overseeing outsourced clinical operations services/vendors
- Experience with financial budgeting/reporting
- Ability to interact with investigators, vendors, and all organizational levels
Benefits:
- Flexible work schedules; remote opportunities; work-life balance
- Shuttle service from BART, CalTrain, and the Ferry
- Base salary, equity participation, employee stock purchase plan, and comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits)