Director, Clinical Trial Management

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.

We are seeking a highly motivated, detail-oriented and results-driven individual to join our company, in the Clinical Operations Department as a Director of Clinical Trial Management who plays an important role in the clinical trial process. As a leader for clinical programs, the Director, CTM is accountable for multiple clinical trials, including quality, timelines, and budget.

Responsibilities:

• Accountable for execution of clinical programs, ensuring that high-quality clinical trials are conducted within the approved budget and timelines
• Provides input to Clinical Development Plans, including forecasts for costs and timelines of proposed clinical trials
• Provides operational input to protocol synopses and protocols
• In conjunction with Clinical Development, determines vendor strategy. Oversees vendor management activities. Authors or approves Vendor Oversight Plan and ensures compliance. Acts as a point of escalation for vendor issues.
• Oversees the development of operational study plans, ensuring conformance to regulatory and GCP requirements, ITI standards, and vendor agreements
• In conjunction with Clinical Development, determines the country / site strategy, considering quality, timelines, and budget
• Ensures efficient study start-up, conduct, and close-out by providing clear direction, anticipating potential obstacles, and employing sound solutions.
• Evaluates operational data to identify risks to program success; implements mitigation strategies and preventive / corrective actions across program.
• Leads and/or contributes to department initiatives (e.g., SOP development, system deployment)
• Provides line management (hiring, training, coaching, performance reviews) to Clinical Trial Managers and Clinical Trial Associates
• Perform other tasks as requested by ITI senior management, 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 in a scientific discipline is required; Master’s degree preferred
• 10+ years in Clinical Operations is required
• CNS experience is required
• People management experience (2+ years) is required
• Excellent communication, organizational, and problem-solving skills
• Strong skills with the Microsoft Office platform (Word, Excel, PowerPoint, and Publisher)
• Strong attention to detail
• Ability to effectively multi-task in a dynamic start-up environment
• Expertise with ICH-GCP guidelines and other clinical trial regulatory requirements
• Other projects and duties as assigned Demonstration of a high level of character and ethics acting in line with a clear and visible set of values & beliefs
• 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 Trial Management Base Salary range $175K - $200K

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