Senior Director, Clinical Development

Role Summary

The Senior Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs, from Phase I through Phase III, ensuring scientific integrity and regulatory compliance. The role involves end-to-end design and execution of clinical programs, collaboration with cross-functional teams, leading regulatory submissions, and establishing partnerships with key opinion leaders and external stakeholders. Location: Brisbane, California (preference for candidates in the San Francisco Bay Area).

Responsibilities

• Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement.
• Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.
• Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA).
• Analyze, interpret, and communicate clinical trial 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 clinical development strategies.
• Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them.

Qualifications

• Required: MD or PhD in Neurology, Neuroscience, or a related field.
• Required: Over 10 years of experience in clinical development, with a focus on CNS-related indications.
• Required: Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development.
• Required: Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment.
• Required: 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.
• Required: Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.
• Required: Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
• Required: Strong analytical and problem-solving skills, with a data-driven approach to decision making.
• Required: Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast-paced environment.
• Preferred: Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
• Preferred: Familiarity with emerging trends in neurology, including cutting-edge therapeutic modalities.