Vice President, Clinical Development-Neuroscience
Annexon Biosciences
2 hours ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Vice President, Clinical Development – Neuroscience
Responsibilities:
- Lead the strategic direction and execution of neuroscience clinical development programs (early-phase through late-stage), ensuring they are scientifically robust and meet regulatory requirements
- 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, marketing authorization dossiers such as BLA/NDA and MAA) aligned with global guidelines (e.g., FDA, EMA)
- Analyze, interpret, and communicate data to inform decisions and recommend clinical development strategy
- Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives
- Manage clinical trial budgets, timelines, and resources to deliver high-quality results aligned with corporate objectives
- Present clinical progress, data outcomes, and strategic recommendations to executive leadership and external partners
- Stay current on industry trends, scientific advancements, and regulatory developments
- Identify clinical development risks (timelines, budgets, regulatory pathways) and develop contingency plans
Required Qualifications/Skills:
- MD or MD/PhD with board certification in Neurology, Neuroscience, or related field
- 15–20 years of clinical development experience focused on CNS-related indications
- Proven leadership designing, managing, and executing clinical trials (early through late stage)
- Senior/executive experience leading clinical development teams (ideally in high-growth biotech/pharma)
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA) and clinical development processes, including HA meetings and briefing books
- Exceptional leadership, strategic thinking, and communication skills; ability to influence across functions/levels
- Ability to work in a fast-paced environment and manage multiple priorities
- Strong analytical/problem-solving skills and data-driven decision making
- Demonstrated success building cross-functional and external collaborations
Preferred Qualifications/Skills:
- 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 and equity participation; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans)
Salary Range: $399,600 – $427,500 USD
Location: Brisbane, California (preference for San Francisco Bay Area candidates)
Responsibilities:
- Lead the strategic direction and execution of neuroscience clinical development programs (early-phase through late-stage), ensuring they are scientifically robust and meet regulatory requirements
- 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, marketing authorization dossiers such as BLA/NDA and MAA) aligned with global guidelines (e.g., FDA, EMA)
- Analyze, interpret, and communicate data to inform decisions and recommend clinical development strategy
- Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives
- Manage clinical trial budgets, timelines, and resources to deliver high-quality results aligned with corporate objectives
- Present clinical progress, data outcomes, and strategic recommendations to executive leadership and external partners
- Stay current on industry trends, scientific advancements, and regulatory developments
- Identify clinical development risks (timelines, budgets, regulatory pathways) and develop contingency plans
Required Qualifications/Skills:
- MD or MD/PhD with board certification in Neurology, Neuroscience, or related field
- 15–20 years of clinical development experience focused on CNS-related indications
- Proven leadership designing, managing, and executing clinical trials (early through late stage)
- Senior/executive experience leading clinical development teams (ideally in high-growth biotech/pharma)
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA) and clinical development processes, including HA meetings and briefing books
- Exceptional leadership, strategic thinking, and communication skills; ability to influence across functions/levels
- Ability to work in a fast-paced environment and manage multiple priorities
- Strong analytical/problem-solving skills and data-driven decision making
- Demonstrated success building cross-functional and external collaborations
Preferred Qualifications/Skills:
- 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 and equity participation; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans)
Salary Range: $399,600 – $427,500 USD
Location: Brisbane, California (preference for San Francisco Bay Area candidates)