The primary responsibilities of this position include medical management of Serious Adverse Events (SAE's) and medical oversight of clinical trials to ensure company Standard Operating Procedures, sponsor directives, and regulatory requirements are followed.
Other responsibilities include medical review of clinical study reports, attending and presenting at investigator and sponsor meetings, providing medical consultation to sponsors and project team members for clinical trial activities including timeframe business development through marketing application.
Education and Experience:
- MD or equivalent
Knowledge, Skills and Abilities:
- Clinical experience/knowledge of a wide range of diseases and pharmaceutical agents
- Knowledge of PPD Standard Operating Procedures and corporate policies
- Knowledge of FDA clinical trial requirements, including safety reporting requirements
- Knowledge of ICH safety reporting requirements and GCPs
- Familiar with international guidelines for conduct of clinical studies
- Working knowledge of biostatistics, data management and clinical procedures
- Overall knowledge of the drug development process
- The duties of this position involve a high degree of complexity in that multiple issues on multiple projects may have to be handled simultaneously
- The position requires a "team player" attitude, although a high degree of independence and self-starting capability is implicit as a requirement of this position
- There is a high degree of independence with respect to decision making and problem solving, but the employee is expected to discuss serious and difficult issues with the reporting supervisor
- Important attributes are the ability to analyze quickly yet with strict attention to minute detail, plan time and approaches to problems and to exercise creativity and judgment in resolving issues
- Good writing and critiquing skills for preparing, reviewing and critiquing reports
- Ability to discipline employees, reward employees and perform timely and effective performance evaluations
- Knowledge of budgeting, forecasting, and fiscal management
- The position requires up to 25% travel, sometimes on short notice
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
- Travel requirements on average 25%
- Long, varied hours required frequently
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
- Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
- Ability to perform under stress.
- Ability to multi-task.
- Regular and consistent attendance.