Senior Director, Clinical Development
Role Overview
This position leads the design and execution of clinical development programs for neuroinflammatory diseases, spanning early-phase to late-stage trials. The individual ensures scientific excellence, regulatory compliance, and strategic alignment with organizational goals, working closely with internal teams and external collaborators to advance novel therapies.
Key Responsibilities
- Direct the strategic planning and implementation of clinical development programs, ensuring scientific validity and adherence to global regulatory standards.
- Partner with clinical operations, regulatory, medical affairs, biostatistics, and pharmacovigilance teams to execute development plans efficiently and effectively.
- Oversee the preparation and submission of clinical trial applications, protocols, and investigator brochures in alignment with FDA, EMA, and other regulatory requirements.
- Interpret clinical data to guide decision-making, delivering actionable insights to shape development strategy.
- Build and maintain relationships with key opinion leaders, investigators, and external partners to support trial enrollment and scientific credibility.
- Manage clinical program budgets, timelines, and resources to ensure high-quality delivery within defined parameters.
- Present clinical progress, data findings, and strategic recommendations to executive leadership and external stakeholders.
- Monitor scientific and regulatory trends to maintain competitive and compliant development approaches.
- Identify risks related to timelines, budget, or regulatory pathways and implement mitigation strategies.
Qualifications
- MD or PhD in Neurology, Neuroscience, or a related discipline.
- Minimum of 10 years of clinical development experience, with a focus on CNS disorders.
- Proven track record in leading clinical trials from Phase 1 through Phase 3 in biotech or pharmaceutical settings.
- Senior-level leadership experience managing cross-functional teams in a fast-paced environment.
- Strong understanding of global regulatory processes, including experience with health authority interactions and briefing document preparation.
- Excellent communication, strategic thinking, and influence skills across organizational levels.
- Ability to manage multiple priorities in a dynamic, evolving landscape.
- Data-driven decision-making approach with strong analytical capabilities.
- Experience building effective collaborations internally and externally.
Preferred Attributes
- Direct experience with regulatory submissions and clinical oversight in biotech or pharma.
- Familiarity with emerging neurology trends and novel therapeutic platforms.
Work Environment
This role operates in a hybrid model, based in Brisbane, California, with flexibility for remote work. Candidates in the San Francisco Bay Area are strongly preferred. The organization supports flexible scheduling and remote opportunities to promote work-life balance.
Compensation & Benefits
- Competitive base salary ranging from $336,000 to $374,000
- Equity participation and employee stock purchase plan
- Comprehensive medical, dental, and vision coverage
- 401(k) with matching and flexible spending accounts
- Shuttle access from major transit points including BART, CalTrain, and Ferry terminals
Company Culture
The organization champions diversity, equity, and inclusion, valuing varied perspectives and non-traditional career paths. It fosters a respectful, open environment where differences are seen as drivers of innovation and better outcomes. All individuals are welcomed, supported, and empowered to contribute fully. Creativity thrives in a culture built on mutual respect and inclusion.
Equal Opportunity Employer
This organization is committed to equal employment opportunity and does not tolerate discrimination or harassment. It actively cultivates an inclusive workplace that respects the unique strengths, backgrounds, and viewpoints of every employee.
