Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

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 22nd 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.

About the Role:

The Executive Director, Clinical Scientist supports the Clinical Program Lead or functions as the Clinical Program Lead in the development of the Clinical Development Plan (CDP) and performs the relevant clinical tasks to ensure successful implementation of the CDP.

Responsibilities:

Clinical Tasks include but are not limited to the creation of the following:

• Protocols/Amendments

• Investigator Brochures

• Informed Consent Forms

• IND Annual Updates

• Clinical Sections of the DSUR

• Clinical Study Reports

• Regulatory Submissions including Meeting Requests, Briefing Books, Efficacy and Safety Summaries

• Scientific Publications

Clinical Tasks as they relate to Clinical Trials include but are not limited to:

• Overseeing multiple studies across one or more compounds

• Representing Clinical Development as a core member on a Clinical Trial Team

• Assisting in the creation of Case Report Forms

• Providing clinical input into clinical trial documents such as lab/ECG specifications and qualification methodology associated with rater training

• Creation and review of training materials

• Coordinating the development of Medical Monitoring and Clinical Oversight Plans

• Performing clinical data review

• Assessing protocol deviations

• Assisting in the resolution of issues identified during clinical data and protocol deviation

• 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.

Requirements:

• Bachelor’s Degree required

• Advanced science degree (Masters or Doctorates) strongly preferred

• Minimum 10 years of overall work experience or equivalent combination of experience and education

• Minimum 8 years of clinical/research experience in the pharmaceutical/device industry preferred

• Scientific knowledge and experience in a related therapeutic area preferred

• Ability to travel at least 30%

• Ability to work in a team setting as well as function as an individual contributor

• Ability to work efficiently and under tight timelines

• Ability to communicate effectively

• Ability to be flexible in an ever-changing environment

• Ability to think strategically and be able to anticipate problems before they occur

• Ability to be proactive in finding solutions to issues

• Proficient in Microsoft office (word, excel, PowerPoint)

• Must be able to perform all essential functions of the position, with or without reasonable accommodation

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.

Executive Director, Clinical Development - Base Salary Range $250,000 - $280,000

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