Vice President, Clinical Development-Neuroscience
Responsibilities
- Lead the strategic direction and execution of the portfolio of neuroscience clinical development programs, from early-phase through late-stage ensuring they are scientifically robust and meet regulatory requirements
- Collaborate cross-functionally with teams in discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs and clinical operations to ensure the successful execution of clinical development plans
- Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, study protocols, and marketing authorization dossiers (e.g., BLA/NDA, MAA) ensuring alignment with global regulatory guidelines (e.g., FDA, EMA)
- Analyze, interpret, and communicate data to inform key decisions, providing clear recommendations to guide clinical development strategy
- Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives
- Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives
- Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners
- Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in the clinical development strategies
- Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them
Requirements
MD or MD/PhD in with board certification in Neurology, Neuroscience, or a related field. 15-20 years of experience in clinical development, with a focus on CNS-related indications. Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development. Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment. In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including Experience in HA meetings, writing briefing books, attending/supporting meetings. Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities. Strong analytical and problem-solving skills, with a data driven approach to decision making. Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast paced environment.
Skills
- Strategic thinking and leadership
- Proven experience in clinical development, particularly in neurodegenerative diseases
- Strong regulatory and compliance background
- Excellent collaboration and communication skills
- Ability to manage complex projects and timelines
- Data analysis and interpretation skills
- Experience in building and maintaining relationships with KOLs, investigators, and external stakeholders
- Knowledge of emerging trends in neurology
Benefits
- Flexible work schedules
- Remote opportunities
- Shuttle service from BART, CalTrain and the Ferry
- Competitive base salary and equity participation
- Employee stock purchase plan
- Comprehensive health benefit package including medical, dental, vision, 401(k), flexible spending plans, and other benefits