Executive Director, Clinical Development
The Executive Director, Clinical Development will play a critical leadership role in advancing our clinical programs in sleep-wake disorders and broader CNS indications. Reporting directly to the Vice President, Clinical Development, this leader will assume primary responsibility for the strategic and operational execution of the company’s late-stage Orexin Receptor 2 Agonist Program (Program 750), which targets narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Given the broad pipeline within the organization, the Executive Director must bring deep experience spanning preclinical through late-stage clinical development, with the ability to shift fluidly across programs as priorities change. In this highly visible, hands-on role, the Executive Director will partner closely with cross-functional teams to provide scientific and medical leadership for clinical study design, execution, data interpretation, and regulatory interactions. Success requires a collaborative, agile mindset; exceptional communication skills; and the ability to influence across a matrixed organization. RESPONSIBILITIES: Primary point of contact for clinical development activities with willingness to work strategically and hands on at the program and clinical trial levels. Accountable for the oversight, monitoring and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and optimal integrity of data. Responsible for establishing relationships and communication with KOLs, investigators and relevant site medical (or other supportive roles) personnel. Lead the clinical development strategy and innovative approaches for the overall clinical pathway for the asset. Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings. Play a key role in regulatory and health authority interactions. Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc. Author asset and clinical trial level plans, charters, documents. Determine optimal clinical trial design options that are innovative, patient centric, cost efficient, and enable meeting business goals. Responsible for review, analysis and interpretation of all clinical trial data including assessment of protocol deviations. Lead asset level clinical sub-teams and play key leadership role on program team for clinical development. Lead asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.). Attend and present as needed at core team meetings, investigator meetings, site visits, etc. Liaise with cross functio...