Senior Director, Clinical Development @ Annexon Biosciences
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About Senior Director, Clinical Development at Annexon Biosciences
Annexon Biosciences is a biopharmaceutical company advancing novel therapies for classical complement-mediated neuroinflammatory diseases affecting the body, brain, and eye. Our innovative approach targets upstream C1q, aiming to block the inflammatory cascade and provide benefits for autoimmune, neurodegenerative, and ophthalmic diseases.
Position Overview
The Senior Director of Clinical Development will drive the clinical strategy and execution of development programs from Phase I through Phase III. You will lead cross-functional teams, manage regulatory submissions, and foster key external partnerships to advance our clinical initiatives in neurology.
Responsibilities
- Lead strategic direction and execution of clinical development programs.
- Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, and more.
- Prepare and manage regulatory filings aligned with FDA and EMA guidelines.
- Analyze clinical trial data and present progress to executive leadership.
- Establish relationships with key opinion leaders and external stakeholders.
- Manage trial budgets, timelines, and resources.
- Stay updated on industry trends and regulatory developments.
- Identify risks and develop contingency plans.
Qualifications
Required: MD or PhD in Neurology, Neuroscience, or related field, over 10 years of clinical development experience (with CNS focus), proven leadership in clinical trials from early to late stage, and in-depth knowledge of global regulatory guidelines.
Preferred: Experience with biotech regulatory submissions, familiarity with emerging neurology trends.
Salary & Location
Salary Range: $336,000 - $374,000. Position is located in Brisbane, California with a preference for candidates in the San Francisco Bay Area.
Benefits
- Competitive base salary and equity participation.
- Comprehensive health benefits including medical, dental, and vision.
- 401(k), flexible spending plans and employee stock purchase plan.
- Flexible work schedules and remote opportunities.
- Shuttle service from BART, CalTrain, and the Ferry.
Key Skills/Competency
- Clinical Strategy
- Regulatory Compliance
- Cross-functional Leadership
- Clinical Trial Design
- Data Analysis
- Neurology
- Global Regulations
- Risk Management
- Team Collaboration
- Stakeholder Engagement
How to Get Hired at Annexon Biosciences
🎯 Tips for Getting Hired
- Research Annexon Biosciences' culture: Understand their innovative biotech approach and values.
- Customize your resume: Highlight clinical trial expertise and leadership.
- Showcase regulatory experience: Detail your work with FDA and EMA submissions.
- Prepare for in-depth interviews: Be ready to discuss clinical strategy and team leadership.