Senior Director, Clinical Development

Responsibilities

• Lead the strategic direction and execution of clinical development programs from early-phase through late-stage trials
• Collaborate cross-functionally with clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics
• Drive preparation, submission, and management of regulatory filings including clinical trial applications and study protocols
• Analyze and communicate clinical trial data to inform development strategy
• Establish and maintain strategic relationships with key opinion leaders (KOLs) and external stakeholders
• Manage clinical trial budgets, timelines, and resources
• Present clinical progress and strategic recommendations to executive leadership
• Identify potential risks in clinical development and develop mitigation plans

Requirements

• MD or PhD in Neurology, Neuroscience, or a related field
• Over 10 years of experience in clinical development with a focus on CNS-related indications
• Proven leadership in designing and executing clinical trials from early to late-stage
• Experience leading clinical development teams at a senior or executive level
• In-depth knowledge of global regulatory requirements (FDA, EMA)
• Experience in HA meetings and writing briefing books
• Strong analytical, problem-solving, and strategic thinking skills

Preferred Qualifications

• Experience with regulatory submissions and clinical trial oversight in biotech or pharma
• Familiarity with emerging trends and therapeutic modalities in neurology

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.