Remote Clinical Development Leader (Director/Senior Director)

Position Summary

The Clinical Development Leader will be responsible for the overall strategy, planning, and execution of clinical development programs for the company's neuroscience-focused product candidates. This role will provide scientific and clinical leadership across all phases of development, contribute to regulatory strategy, and collaborate cross-functionally to advance products from early development through commercialization. The successful candidate will serve as a key clinical expert within the organization, providing strategic guidance to senior leadership and leading a high-performing clinical team.

Key Responsibilities

Clinical Development Strategy & Execution

• Contribute to the development and execution of clinical development strategies for neuroscience product candidates.
• Lead the design, planning, implementation, and oversight of clinical trials across Phases I–IV.
• Ensure clinical programs are executed efficiently, meeting scientific, regulatory, and business objectives.
• Provide clinical leadership and strategic input for development plans and program decisions.

Regulatory & Scientific Contributions

• Contribute to regulatory strategies supporting successful product development and commercialization.
• Prepare and review regulatory submissions and documentation, including INDs, annual reports, briefing packages, and NDAs.
• Serve as a key contributor during interactions with regulatory agencies, including the FDA, EMA, and other global health authorities.
• Ensure clinical studies are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, and company SOPs.

Clinical Documentation & Reporting

• Lead the development, review, and approval of key clinical trial documents, including:
  • Clinical protocols
  • Statistical Analysis Plans (SAPs)
  • Investigator Brochures (IBs)
  • Clinical Study Reports (CSRs)
• Provide clinical updates and strategic recommendations to senior leadership.
• Contribute clinical content for Board of Directors presentations, investor communications, and financial disclosures.

Publications & External Engagement

• Contribute to scientific publications, including abstracts, posters, presentations, and manuscripts for scientific meetings and peer-reviewed journals.
• Represent the company at relevant scientific and medical conferences.
• Maintain awareness of emerging scientific, clinical, and competitive developments within neuroscience and related therapeutic areas.

Cross-Functional Leadership

• Collaborate closely with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Manufacturing, Commercial, and Nonclinical teams.
• Support process improvements and company-wide initiatives to enhance clinical development capabilities.
• Contribute to the development and maintenance of SOPs, guidelines, and work instructions.

People Leadership

• Lead, mentor, develop, and retain a highly skilled clinical development team.
• Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement.
• Participate in recruiting, hiring, performance management, and professional development activities.

Qualifications

Education

• Advanced scientific degree required, such as PhD, PharmD, MD, or MD/PhD.
• PhD in Neuroscience or a related field is required.
• Neuroscience industry experience is required, with strong preference for candidates possessing both a neuroscience PhD and industry experience.

Experience

• Director: Minimum of 5 years of clinical science or clinical development experience within the pharmaceutical or biotechnology industry.
• Senior Director: Significant additional experience leading complex clinical development programs.
• Proven experience planning, conducting, and managing clinical development programs across Phases I–IV.
• Experience supporting regulatory submissions and interactions with global regulatory authorities.
• Prior people leadership experience, including hiring, coaching, developing, and managing high-performing teams.

Knowledge & Skills

• Deep understanding of drug development and clinical research processes.
• Comprehensive knowledge of GCP, ICH guidelines, and global clinical research regulations.
• Strong understanding of cross-functional disciplines including Clinical Operations, Regulatory Affairs, Medical Affairs, Nonclinical Development, Manufacturing, and Commercial functions.
• Demonstrated ability to manage multiple complex projects and competing priorities in a dynamic environment.
• Excellent analytical, organizational, and strategic thinking skills.
• Strong interpersonal, communication, presentation, and influencing abilities.
• Proven ability to resolve conflicts, solve complex problems, and build alignment across stakeholders.
• Self-motivated, adaptable, and capable of thriving in a fast-paced biotechnology environment.

Additional Requirements

• Must have CNS expereince

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