Senior Medical Director, PVG - 142896
Medical management of SAEs and medical oversight of clinical trials to ensure company SOPs, sponsor directives, and regulatory requirements are followed. Performs 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. May have responsibility for direct staff management for assigned physicians in the PVG department. *LI-DR1
Education and Experience:
- MD or equivalent
- 3 years of pharmaceutical industry experience
- 2+ years medical affairs/pharmacovigilance/ SAE review experience
- Or equivalent combination of knowledge, skills and abilities to perform the essential job functions
Knowledge, Skills and Abilities:
- Mastery of basic medical management tasks such as SAE review, lab review, protocol inquiries and listing review
- Ability to effectively mentor others
- Strong medical knowledge and 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
- Expert knowledge of regulatory guidelines for adverse event reporting for serious/unexpected events
- Expert knowledge of Federal Guidelines and GCPs, including ICH/regional regulatory safety reporting requirements
- 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
- Expert knowledge of the drug development process
- Ability to effectively manage resources and budgets
- 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 tolisten 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 planswork 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.