Director/Senior Director, Clinical Development

$200,000 - $250,000/Yr

Intra-Cellular Therapies - Bedminster, NJ

Full-time - Senior

Bedminster, NJ

Chemical Manufacturing

About the position

The Director/Senior Director of Clinical Development at Intra-Cellular Therapies, Inc. is responsible for leading and overseeing clinical studies in psychiatry, ensuring medical integrity and compliance throughout the study lifecycle. This role involves strategic planning, medical monitoring, and collaboration with various teams to deliver high-quality clinical data and reports. The position is hybrid, requiring in-office presence on Tuesdays and Wednesdays.

Responsibilities

• Provide cross-functional Clinical Development leadership for internal and external team members in the delivery of clinical studies.
• Participate in the strategic planning of clinical studies and programs, including study design and key deliverables.
• Support and oversee all functional areas of study teams throughout the study lifecycle to ensure data integrity and adherence to study goals.
• Act as the primary contact for medical communication to ensure medical safety within studies and maintain relationships with sites and Investigators.
• Conduct medical monitoring, including reviewing participant eligibility and protocol interpretation, in collaboration with Clinical Operations and Data Management.
• Contribute to the analysis and interpretation of clinical results with Biometrics.
• Author and review clinical sections of regulatory documents and study-specific documents.
• Represent Clinical Development at Regulatory Authority Meetings and present clinical development aspects at internal or external meetings.
• Communicate potential issues, risks, or changes to the Clinical Development Plan to Senior Management.

Requirements

• MD degree, US Licensed
• Specialty training in Psychiatry
• Minimum 3+ years of clinical/research experience in the pharmaceutical industry 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 anticipate problems
• Proficient in Microsoft Office (Word, Excel, PowerPoint)

Benefits

• 401K
• Dental
• Life
• Medical
• Vision