Medical Director, Internal Medicine/Pediatrics
This individual will be primarily responsible for the independent direction of Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). As needed, will interface with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans. Responsible for medical oversight of Drug Safety activities in conjunction with operational activities of the Drug Safety Director.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop and implement study protocols consistent with the Development Team direction;
- Assist in the identification and selection of clinical investigators for clinical trials;
- Maintain appropriate communication and professional relationship with NBI Clinical Investigators;
- Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies;
- Oversee the clinical trials program in conjunction with the Clinical Operations; analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management;
- Participate on multidisciplinary project teams;
- Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs;
- Assist in the recruitment, training and development of the clinical teams;
- Identify and select clinical consultants;
- Provide or assist in the scientific writing and review of clinical study reports and related documents;
- Provide periodic status updates and effectively communicate with Senior Management Team
The Director must have an advanced degree (MD or DO) with specialty training appropriate to an internal medicine therapeutic area, preferably in endocrinology or pediatrics. In addition to a minimum of 5 years’ experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company; prior experience working with CRO is a plus. Extensive knowledge of clinical drug development is mandatory and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data. The Director should be able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel. Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required.