Medical Director- Psychiatry (US Based Only - Board-certified in Psychiatry is required)

Job Responsibilities

• Provides medical oversight of assigned clinical studies in the capacity as a medical monitor.
• Serves as the primary medical contact for customers regarding assigned clinical studies.
• Contributes to medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff.
• Provides medical and therapeutic input during Study Start Up, Feasibility, and Subject Identification efforts.
• Reviews and provides input into protocol design and amendments.
• Participates in data collection tools, monitoring plans, and review and analysis plans.
• Oversees assigned Medical Scientist staff and Medical Director colleagues to review clinical data.
• Presents trends and issues, along with mitigation strategies, to customers and project team members.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations, as well as national and ICH Good Clinical Practice (GCP) guidelines.
• Supports responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), if requested.
• Provides input to clinical development or regulatory teams within the Company, if requested.
• Represents the Company at scientific meetings, if requested.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans.
• Adheres to customer policies and standard operating procedures, as required in project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
• May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
• May provide input to clinical development or regulatory teams within the Company, upon request.
• May represent the Company at scientific meetings, upon request.
• Performs the duties of Medical Monitor.

Qualifications

Board-certified in Psychiatry is required.

Benefits

The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

Pay

$146,000.00 - $332,000.00

Schedule

Not specified