Associate Director, Clinical Trial Management
Annexon Biosciences
9 days ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Associate Director of Clinical Trial Management
Responsibilities:
- Oversee and execute multiple clinical trials
- Develop, implement, and provide oversight of vendor budgets and contracts
- Track and report study metrics
- Identify and mitigate 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 and trial conduct (e.g., protocols, monitoring plans, clinical trial reports, investigator brochures)
- Stay current on therapeutic areas, industry practices/trends, and FDA requirements; apply to current programs
- Partner with and maintain regular contact with key stakeholders (Regulatory, Clinical Development, Legal, Finance, as needed)
- Lead selection of Contract Research Organizations (CROs) for large and small budgets
- Attend CRO/vendor meetings (e.g., kick-offs, investigator meetings, quarterly meetings) to ensure alignment and achievement of study goals
- Contribute to Clinical Operations functional initiatives and best practices
- Travel up to 30% as needed
Required Qualifications:
- BS/BA in related discipline (or equivalent education/experience)
- 10+ years leading clinical trial operations, including multinational/multisite studies; experience in ophthalmology, neurology, rare diseases, and drug development; hands-on leadership and direct line-management of clinical operations staff
- Thorough knowledge of clinical development process and FDA/EMA and other regulatory requirements; ICH and GCP guidelines
- Demonstrated success identifying, negotiating, and overseeing outsourced clinical operations services/vendors
- Experience with budgeting or reporting
- Ability to interact with investigators, vendors, and all organizational levels
Benefits:
- Flexible work schedules, remote opportunities, and work-life balance
- Shuttle service from BART, CalTrain, and the Ferry
- Competitive base salary and equity; employee stock purchase plan
- Comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans, and other benefits
Responsibilities:
- Oversee and execute multiple clinical trials
- Develop, implement, and provide oversight of vendor budgets and contracts
- Track and report study metrics
- Identify and mitigate 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 and trial conduct (e.g., protocols, monitoring plans, clinical trial reports, investigator brochures)
- Stay current on therapeutic areas, industry practices/trends, and FDA requirements; apply to current programs
- Partner with and maintain regular contact with key stakeholders (Regulatory, Clinical Development, Legal, Finance, as needed)
- Lead selection of Contract Research Organizations (CROs) for large and small budgets
- Attend CRO/vendor meetings (e.g., kick-offs, investigator meetings, quarterly meetings) to ensure alignment and achievement of study goals
- Contribute to Clinical Operations functional initiatives and best practices
- Travel up to 30% as needed
Required Qualifications:
- BS/BA in related discipline (or equivalent education/experience)
- 10+ years leading clinical trial operations, including multinational/multisite studies; experience in ophthalmology, neurology, rare diseases, and drug development; hands-on leadership and direct line-management of clinical operations staff
- Thorough knowledge of clinical development process and FDA/EMA and other regulatory requirements; ICH and GCP guidelines
- Demonstrated success identifying, negotiating, and overseeing outsourced clinical operations services/vendors
- Experience with budgeting or reporting
- Ability to interact with investigators, vendors, and all organizational levels
Benefits:
- Flexible work schedules, remote opportunities, and work-life balance
- Shuttle service from BART, CalTrain, and the Ferry
- Competitive base salary and equity; employee stock purchase plan
- Comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans, and other benefits