Vice President, Clinical Development-Neuroscience
Annexon Biosciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Position: Vice President, Clinical Development—Neuroscience
Responsibilities:
- Lead the strategic direction and execution of neuroscience clinical development programs from early- to late-stage, ensuring scientific robustness and regulatory alignment.
- Collaborate cross-functionally with discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs, and clinical operations to execute clinical development plans.
- Drive preparation, submission, and management of regulatory filings (e.g., clinical trial applications, investigator brochures, study protocols, BLA/NDA, MAA) aligned with global guidelines (FDA, EMA).
- Analyze, interpret, and communicate data to inform decisions and guide clinical development strategy.
- Establish relationships with KOLs, clinical investigators, and external stakeholders to advance clinical initiatives.
- Manage clinical trial budgets, timelines, and resources to deliver high-quality outcomes.
- Present clinical progress, data outcomes, and recommendations to executive leadership and external partners.
- Monitor industry trends, scientific advancements, and regulatory developments.
- Identify clinical development risks in timelines, budgets, or regulatory pathways and develop contingency plans.
Required:
- MD or MD/PhD with board certification in Neurology/Neuroscience (or related field).
- 15–20 years clinical development experience focused on CNS indications.
- Proven leadership designing, managing, and executing Phase I–III trials.
- Senior/executive-level experience leading clinical development teams (biotech/pharma).
- In-depth knowledge of global regulatory requirements and clinical development processes (e.g., HA meetings, briefing books).
- Strong leadership, strategic thinking, and communication; ability to influence across functions.
- Ability to work in a fast-paced environment; manage multiple priorities.
- Strong analytical/problem-solving skills with data-driven decision-making.
- Demonstrated success building collaborations with cross-functional 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, and work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary plus equity participation; employee stock purchase plan.
- Comprehensive health benefits: medical, dental, vision, 401(k), flexible spending plans, and other benefits.
Responsibilities:
- Lead the strategic direction and execution of neuroscience clinical development programs from early- to late-stage, ensuring scientific robustness and regulatory alignment.
- Collaborate cross-functionally with discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs, and clinical operations to execute clinical development plans.
- Drive preparation, submission, and management of regulatory filings (e.g., clinical trial applications, investigator brochures, study protocols, BLA/NDA, MAA) aligned with global guidelines (FDA, EMA).
- Analyze, interpret, and communicate data to inform decisions and guide clinical development strategy.
- Establish relationships with KOLs, clinical investigators, and external stakeholders to advance clinical initiatives.
- Manage clinical trial budgets, timelines, and resources to deliver high-quality outcomes.
- Present clinical progress, data outcomes, and recommendations to executive leadership and external partners.
- Monitor industry trends, scientific advancements, and regulatory developments.
- Identify clinical development risks in timelines, budgets, or regulatory pathways and develop contingency plans.
Required:
- MD or MD/PhD with board certification in Neurology/Neuroscience (or related field).
- 15–20 years clinical development experience focused on CNS indications.
- Proven leadership designing, managing, and executing Phase I–III trials.
- Senior/executive-level experience leading clinical development teams (biotech/pharma).
- In-depth knowledge of global regulatory requirements and clinical development processes (e.g., HA meetings, briefing books).
- Strong leadership, strategic thinking, and communication; ability to influence across functions.
- Ability to work in a fast-paced environment; manage multiple priorities.
- Strong analytical/problem-solving skills with data-driven decision-making.
- Demonstrated success building collaborations with cross-functional 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, and work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary plus equity participation; employee stock purchase plan.
- Comprehensive health benefits: medical, dental, vision, 401(k), flexible spending plans, and other benefits.