Associate Director, 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, and compliance
• Develop and manage relationships with Investigators and clinical opinion leaders
• Provide technical expertise for clinical documents including protocols and monitoring plans
• Lead the selection of Contract Research Organizations (CROs)
• Attend vendor meetings and investigator meetings
• Manage and mentor direct reports from Manager to entry level

Requirements

• BS/BA degree in a related discipline or equivalent experience
• 10+ years of experience leading clinical trial operations
• Experience with multinational/multisite clinical studies
• Background in ophthalmology, neurology, or rare diseases
• Thorough knowledge of FDA, EMA, ICH, and GCP guidelines
• Proven success in negotiating and overseeing outsourced clinical services
• Experience with financial budgeting and reporting

Benefits

• Flexible work schedules and remote opportunities
• Shuttle service from BART, CalTrain, and the Ferry
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefits including medical, dental, and vision
• 401(k) and flexible spending plans

About the Company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.