Senior Director Clinical Development
Annexon Biosciences
August 19, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Sr. Director of Clinical Development
Responsibilities:
- Lead the strategic direction and execution of clinical development programs from early- to late-stage trials.
- Collaborate cross-functionally with clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics.
- Drive preparation, submission, and management of regulatory filings (clinical trial applications, investigator brochures, study protocols) in alignment with FDA/EMA.
- Analyze, interpret, and communicate clinical trial data to inform key decisions.
- 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 stakeholders.
- Monitor industry trends, scientific advancements, and regulatory developments.
- Identify risks across timelines, budgets, and regulatory pathways and develop contingency plans.
Required Qualifications/Skills:
- MD or PhD in Neurology, Neuroscience, or related field.
- 10+ years of clinical development experience in CNS-related indications.
- Proven leadership designing, managing, and executing clinical trials (Phase I–III).
- Senior/executive-level experience leading clinical development teams in biotech/pharma.
- In-depth knowledge of global regulatory requirements (FDA/EMA); experience with HA meetings, briefing books, and meeting support.
- 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 problem-solving skills.
- Demonstrated success building collaborations with cross-functional teams and external partners.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in biotech/pharma.
- Familiarity with emerging neurology trends and therapeutic modalities.
Benefits:
- Flexible work schedules, remote opportunities, work-life balance; shuttle service from BART/CalTrain/Ferry; competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans.
Salary Range: $336,000 - $374,000
Location: Brisbane, CA (preference for San Francisco Bay Area).
Responsibilities:
- Lead the strategic direction and execution of clinical development programs from early- to late-stage trials.
- Collaborate cross-functionally with clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics.
- Drive preparation, submission, and management of regulatory filings (clinical trial applications, investigator brochures, study protocols) in alignment with FDA/EMA.
- Analyze, interpret, and communicate clinical trial data to inform key decisions.
- 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 stakeholders.
- Monitor industry trends, scientific advancements, and regulatory developments.
- Identify risks across timelines, budgets, and regulatory pathways and develop contingency plans.
Required Qualifications/Skills:
- MD or PhD in Neurology, Neuroscience, or related field.
- 10+ years of clinical development experience in CNS-related indications.
- Proven leadership designing, managing, and executing clinical trials (Phase I–III).
- Senior/executive-level experience leading clinical development teams in biotech/pharma.
- In-depth knowledge of global regulatory requirements (FDA/EMA); experience with HA meetings, briefing books, and meeting support.
- 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 problem-solving skills.
- Demonstrated success building collaborations with cross-functional teams and external partners.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in biotech/pharma.
- Familiarity with emerging neurology trends and therapeutic modalities.
Benefits:
- Flexible work schedules, remote opportunities, work-life balance; shuttle service from BART/CalTrain/Ferry; competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision), 401(k), flexible spending plans.
Salary Range: $336,000 - $374,000
Location: Brisbane, CA (preference for San Francisco Bay Area).