Assoc Medical Director (Infectious Disease)

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.

**THIS ROLE ALLOWS FOR A HOME BASED EMPLOYEE**

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.

**THIS ROLE ALLOWS FOR A HOME BASED EMPLOYEE**

Education and Experience: MD degree (formally trained ID sub-specialty REQUIRED) or equivalent 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 event reporting 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

Working Conditions: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 Physical Demands: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. PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.Education and Experience: MD degree (formally trained ID sub-specialty REQUIRED) or equivalent 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 event reporting 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

Working Conditions: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 Physical Demands: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. PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.US-NC-Wilmington-Wilmington NC HQ, Latin America, US-Massachusetts, US-Maryland, US-New York, US-NY-New York, US-Washington, US-California, US-District of Columbia-Washington, DC, US-Pennsylvania, US-Colorado, US-New Jersey, BR-BR-Sao Paulo, US-Virginia, US-Georgia, US-Illinois, US-TX-Austin, US-Florida, BrazilUS-NC-Wilmington-Wilmington NC HQ, Latin America, US-Massachusetts, US-Maryland, US-New York, US-NY-New York, US-Washington, US-California, US-District of Columbia-Washington, DC, US-Pennsylvania, US-Colorado, US-New Jersey, BR-BR-Sao Paulo, US-Virginia, US-Georgia, US-Illinois, US-TX-Austin, US-Florida, Brazil