Our client company is seeking a Director / Senior Director, Clinical Development (Neuroscience) to serve as a physician leader within the clinical development organization. This role will be responsible for designing and executing clinical programs, providing medical oversight, and driving strategy to support regulatory approvals and successful development of innovative therapies.
Key Responsibilities
Clinical Strategy & Leadership
- Lead the clinical development strategy for one or more neuroscience programs
- Serve as the medical lead on cross-functional teams, driving program direction and decision-making
- Contribute to overall asset strategy, including indication selection, lifecycle planning, and differentiation
- Develop and maintain Target Product Profiles (TPPs) and clinical development plans
Study Design & Execution
- Design clinical trial protocols (Phase I–IV), including endpoints, eligibility criteria, and study methodology
- Provide medical oversight for clinical trials to ensure scientific integrity and patient safety
- Act as Medical Monitor, supporting investigators and addressing protocol-related questions
- Partner with clinical operations and CROs to ensure timely, high-quality study execution
- Support site selection, feasibility assessments, and investigator engagement
Data Review & Interpretation
- Review ongoing clinical data, including safety signals and efficacy trends
- Lead data interpretation and make recommendations to optimize study outcomes
- Contribute to clinical study reports (CSRs), abstracts, and publications
- Present data to internal stakeholders, executive leadership, and external audiences
Regulatory & Submissions
- Support regulatory strategy and contribute to interactions with health authorities, including the U.S. Food and Drug Administration
- Contribute to regulatory documents (INDs, NDAs, briefing books, and responses)
- Participate in regulatory meetings and advisory discussions (preferred)
- Ensure studies are conducted in compliance with GCP and regulatory requirements
Cross-Functional Collaboration
- Collaborate with clinical operations, biostatistics, safety/pharmacovigilance, regulatory, and medical affairs teams
- Provide medical input into statistical analysis plans, safety monitoring, and risk management
- Partner with commercial and medical affairs teams on scientific messaging and launch readiness
External Engagement
- Build relationships with key opinion leaders (KOLs), investigators, and academic partners
- Represent the company at scientific conferences, advisory boards, and investigator meetings
- Collaborate with external vendors and CROs; contribute to vendor selection and oversight
Operational & Leadership Responsibilities
- Ensure delivery of clinical program milestones (timelines, budget, quality)
- Identify risks and implement mitigation strategies across programs
- Mentor junior team members and contribute to building clinical capabilities
- Contribute to due diligence for business development opportunities
- Support clinical trial registry postings (e.g., ClinicalTrials.gov) and transparency requirements
Qualifications
- MD required (board certification preferred)
- Neuroscience expertise required (neurology, psychiatry, or related field strongly preferred; academic experience a plus)
- Minimum 4–5+ years of industry experience in clinical development (pharma, biotech, or CRO)
- Experience serving as a medical monitor and leading clinical trials
- Strong knowledge of clinical trial design, data interpretation, and regulatory requirements
- Experience with regulatory submissions preferred but not required
- Excellent communication, leadership, and cross-functional collaboration skills
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