Associate Director, Clinical Pharmacology

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We develop innovative treatments to improve the lives of individuals suffering from neuropsychiatric and neurologic 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 20^th 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.

The Associate Director, Clinical Pharmacology designs clinical pharmacology development plans to support drug development and registration, leads the conduct of clinical pharmacology studies, authors and/or supports the development of various documents such as study protocols and clinical study reports, contributes to various regulatory documents and interactions, and serves as a clinical pharmacology subject matter expert. The position requires close collaboration with individuals across various departments, including but not limited to Clinical Development, Clinical Pharmacology Operations, Biometrics, and Regulatory Affairs. 

Job Responsibilities

• Design clinical pharmacology development plans for assigned projects
• Lead the conduct of clinical pharmacology studies and serve as Study Director for the assigned studies
• Author or contribute to the authoring of clinical pharmacology protocols and clinical study reports
• Support pharmacokinetic (PK) and pharmacodynamic (PD) evaluations in late-stage clinical development studies
• Support various clinical study operational activities, such as review of case report forms, eCRF guidelines, monitoring plans, study procedure manuals, pharmacy manuals, and laboratory manuals
• Review/author informed consent forms, assent forms, pregnant partner consent forms, and support their submission to IRBs/ECs
• Support site and vendor selection activities
• Develop and deliver study specific training presentations 
• Assess protocol deviations 
• Assist in the resolution of issues identified during clinical data and protocol deviation reviews
• Perform PK and PK/PD analyses. Ensure that PK/PD analyses done by external vendors meet company standards
• Author and/or review PK and PK/PD analysis plans. Contribute to the preparation of overall study/safety SAP
• Perform clinical data review of data listings and summary tables
• Author eCTD Module 2.7.2 (Summary of Clinical Pharmacology Studies) and Module 2.7.1 (Summary of Biopharmaceutic Studies). Support the preparation of other eCTD sections as well as various other regulatory documents such as DSURs, IND annual updates, Briefing Books, and Investigator Brochures 
• Interact with regulatory authorities. Support the writing and reviewing of clinical pharmacology queries from regulatory agencies
• Collaborate with CMC, Regulatory, and other groups in formulation development and bridging activities.
• Assist in process improvement initiatives and SOP development where applicable
• Author manuscripts for publication in peer-reviewed journals
• May participate in in-licensing opportunities
• 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

• 5 years or more experience in clinical pharmacology, clinical pharmacokinetics or a related scientific discipline
• In-depth knowledge of pharmacokinetic and other analysis software programs (e.g. WinNonlin)
• Knowledge of GCP/ICH guidelines and Food and Drug Administration (FDA) regulations
• Ability to work in a team setting as well as function as an individual contributor
• Ability to work efficiently and under tight timelines
• Strong communication skills and presentation skills, verbal and written 
• Ability to travel (about 5%)
• 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.

Director, Clinical Pharmacology Base Salary range $195K - $215K

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