Executive Director - Clinical Development

·         MD in neurology or psychiatry (board certification preferred)

·         Clinical and/or academic experience in neurological disorders; and 8+ years of pharmaceutical industry experience

·         Translational medicine expertise highly desired

·         Experience in early clinical development through late stage with successful design and implementation of proof-of-concept studies; submission experience in the neuroscience area is desired.

·         Knowledge of US and EU regulatory guidelines and experience in interactions with regulatory agencies

·         Outstanding written and verbal communication, with a passion for problem solving and effective cross-functional stakeholder engagement.

·         Ability to work independently and thrive in a fast-paced dynamic matrix environment.

·         An entrepreneurial spirit with high degree of energy and personal accountability

·         Serve as a clinical leader for assigned early-stage program(s), providing medical and scientific ownership, while maintaining readiness to support later‑stage or emerging programs.

·         Author and oversee clinical study protocols for orexin receptor agonists, ensuring scientific rigor, operational feasibility, and alignment with regulatory expectations.

·         Contribute to and help develop integrated clinical development plans (CDPs) spanning preclinical translation through late‑stage trials, enabling efficient advancement of multiple candidate molecules.

·         Collaborate closely with Clinical Operations to meet quality, timeline, and budget expectations across all studies within the assigned program(s) and other CNS programs as needed.

·         Provide real‑time medical and scientific guidance for ongoing clinical trials, including data review, safety oversight, and acceleration of development programs.

·         Partner with our translational groups to support biomarker strategy, dose selection, and evaluation of indication expansion opportunities.

·         Communicate clinical and scientific updates clearly across internal teams and external stakeholders.

·         Contribute to the preparation, authorship, and review of clinical sections of regulatory submissions, including INDs, protocol amendments, briefing documents, annual reports, safety reports, and clinical study reports.

·         Ensure robust oversight of safety monitoring and adherence to Good Clinical Practice (GCP), pharmacovigilance standards, internal SOPs, and quality requirements.

·         Support regulatory interactions with global health authorities, including preparation for key meetings, responses, and ongoing communication.

·         Provide oversight of study integrity, safety, efficacy data, and risk‑benefit assessments across assigned programs.

·         Ensure that clinical insights and external evidence are synthesized and used to guide strategic decision‑making across the portfolio.