Senior Director Clinical Development
Annexon Biosciences
July 02, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Responsibilities:
- Lead the strategic direction and execution of clinical development programs (early-phase through late-stage) ensuring scientific robustness and regulatory compliance.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Biostatistics to execute clinical development plans.
- Drive preparation, submission, and management of regulatory filings (e.g., clinical trial applications, investigator brochures, study protocols) aligned with FDA/EMA guidance.
- Analyze, interpret, and communicate clinical trial data to inform key decisions and recommendations.
- Establish and maintain relationships with KOLs, clinical investigators, and external stakeholders.
- Manage clinical trial budgets, timelines, and resources to deliver high-quality results.
- Present clinical progress, data outcomes, and recommendations to executive leadership and external partners.
- Monitor industry trends, scientific advancements, and regulatory developments to maintain competitive clinical strategies.
- Identify risks in timelines, budgets, or regulatory pathways and develop contingency plans.
Qualifications/Skills:
Required:
- MD or PhD in Neurology, Neuroscience, or related field.
- 10+ years clinical development experience focused on CNS-related indications.
- Proven leadership designing, managing, and executing clinical trials (Phase I–III).
- Senior/executive-level leadership experience in biotech/pharma.
- In-depth knowledge of global regulatory requirements (FDA/EMA); experience with HA meetings, briefing books, and supporting meetings.
- Exceptional leadership, strategic thinking, and communication; ability to influence across functions.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong analytical and data-driven decision-making skills.
- Track record building cross-functional and external collaborations.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in biotech/pharma.
- Familiarity with emerging neurology trends and therapeutic modalities.
Benefits:
- Flexible work schedules and remote opportunities; work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity participation; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans, and other benefits.
Compensation:
- Salary range: $336,000–$374,000.
- Lead the strategic direction and execution of clinical development programs (early-phase through late-stage) ensuring scientific robustness and regulatory compliance.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Biostatistics to execute clinical development plans.
- Drive preparation, submission, and management of regulatory filings (e.g., clinical trial applications, investigator brochures, study protocols) aligned with FDA/EMA guidance.
- Analyze, interpret, and communicate clinical trial data to inform key decisions and recommendations.
- Establish and maintain relationships with KOLs, clinical investigators, and external stakeholders.
- Manage clinical trial budgets, timelines, and resources to deliver high-quality results.
- Present clinical progress, data outcomes, and recommendations to executive leadership and external partners.
- Monitor industry trends, scientific advancements, and regulatory developments to maintain competitive clinical strategies.
- Identify risks in timelines, budgets, or regulatory pathways and develop contingency plans.
Qualifications/Skills:
Required:
- MD or PhD in Neurology, Neuroscience, or related field.
- 10+ years clinical development experience focused on CNS-related indications.
- Proven leadership designing, managing, and executing clinical trials (Phase I–III).
- Senior/executive-level leadership experience in biotech/pharma.
- In-depth knowledge of global regulatory requirements (FDA/EMA); experience with HA meetings, briefing books, and supporting meetings.
- Exceptional leadership, strategic thinking, and communication; ability to influence across functions.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong analytical and data-driven decision-making skills.
- Track record building cross-functional and external collaborations.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in biotech/pharma.
- Familiarity with emerging neurology trends and therapeutic modalities.
Benefits:
- Flexible work schedules and remote opportunities; work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity participation; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans, and other benefits.
Compensation:
- Salary range: $336,000–$374,000.