Director, Clinical Development (New York)

Director, Clinical Development

Intra-Cellular Therapies Inc. is a publicly traded, biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 23rd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

Director, Clinical Development, will be responsible for the leadership, oversight, and medical integrity of psychiatry studies / programs. This individual will monitor clinical studies, review and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and strategy.

Job Responsibilities

• Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies :
• Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables.
• Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and / or escalate issues, achieve alignment, and adhere to study goals and timelines.
• Act as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites and Investigators.
• Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management.
• Work with Biometrics to contribute to the analysis and interpretation of clinical results.
• Author, review, and / or provide strategic input into :
• Clinical sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents.
• Study specific documents such as study protocols / amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports.
• Scientific publications, manuscripts, posters, or other documents intended for external audiences.
• Represent Clinical Development at Regulatory Authority Meetings.
• Present the clinical development aspects of a project and clinical trial results at internal or external meetings.
• Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan.
• Complete all company and job-related training as assigned within the required timelines.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities, and activities may change at any time with or without notice.

Job Requirements

Intra-Cellular Therapies is an Equal Employment Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Director, Clinical Development Base Salary Range : $180K - $240K