Senior Director - Clinical Research
- Experience Level
Senior Director – Clinical Research
On behalf of my client, I am recruiting for a Senior Director – Clinical Research.
The successful candidate will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on paediatric viral infectious diseases.
• Interfaces with staff to share scientific and clinical information and consistent practices.
• Leads/supports protocol review discussions concerning scientific and procedural aspects of study design.
• Serves as resource for junior staff, and creates effective teams with a clear sense of direction.
• Oversees the scientific aspects of clinical studies throughout duration of study.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as company SOPs.
• Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
• Supervises or assists other CR staff with preparation of above. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
• Helps ensure consistency across protocols, and present scientific information if needed.
• Addresses questions regarding scientific and related procedural issues from Investigators.
• Coordinates and implements ongoing data for internal analysis and review.
• Coordinates/supports the preparation/review of regulatory documents, PIPs/PSPs, safety reports, Investigator Brochures, and NDAs.
• Determines the functions most critical to company success and supports priorities within functional area.
• Anticipates fairly complex obstacles and implements solutions that meet goals.
• May lead two or more specific components of departmental strategic initiatives.
• Typically requires a higher degree MD, with significant years in clinical research or clinical pharmacology in a pharmaceutical company, CRO or academic institution
• Experience in paediatric medicine and/or paediatric drug development will be highly desirable
• Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
• Examines functional issues from a broader organization perspective.
• Knowledge of clinical trial design to develop specific study concept sheets and protocols is required.
• Familiarity with virology and HIV medicine preferred
• Clinical or translational research experience preferred
• Pharmaceutical/Biotech industry experience in clinical development preferred
• Successful leadership and management experience
• Excellent organizational and communication skills are critical