Remote- Director, Clinical Development Leader (CNS)

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 ...