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.
- MD degree (IM with Pulmonary Subspecialty) or equivalent & active US license
Knowledge, Skills and Abilities:
- Strong medical knowledge.
- Strong analytical skills.
- Excellent oral and written communication skills.
- Excellent interpersonal and team building skills.
- Excellent negotiating skills.
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem solve.
- Ability to exercise creativity and judgment.
- Understanding of regulatory guidelines for adverse eventreporting for serious/unexpected events.
- Working knowledge of Federal Guidelines and GCPs.
- Familiar with guidelines for IND and NDA submissions and international guidelines for conduct of clinical studies.
- Working knowledge of biostatistics, data management, and clinical operations' procedures.
- Overall knowledge of the drug development process
- 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.
- 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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.