Neurology Medical Director - Contract Opening - Functional Service Partnership

Submission for the position: Neurology Medical Director - Contract Opening - Functional Service Partnership - (Job Number: 184063)

Client-Dedicated (Functional Service Partnership Business Unit)

Contract/Temporary Opening

Work Remotely

Once travel restrictions are lifted, this position will require travel to Boston, MA 1-2 times a month if located in the United States.

Once travel restrictions are lifted, this position will require travel to Ghent, Belgium 1-2 times a month if located in Belgium.

Summary

Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Major Responsibilities

Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.

Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.

Provides therapeutic training and protocol training on assigned studies, as requested.

Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Contributes to departmental process improvement initiatives.

Clinical Trial Support:

Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.

Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.

Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.

Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.

Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

Client-Dedicated (Functional Service Partnership Business Unit)

Contract/Temporary Opening

Work Remotely

Once travel restrictions are lifted, this position will require travel to Boston, MA 1-2 times a month if located in the United States.

Once travel restrictions are lifted, this position will require travel to Ghent, Belgium 1-2 times a month if located in Belgium.

Summary

Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Major Responsibilities

Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.

Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.

Provides therapeutic training and protocol training on assigned studies, as requested.

Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Contributes to departmental process improvement initiatives.

Clinical Trial Support:

Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.

Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.

Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.

Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.

Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Education and Experience:

MD or equivalent required. Active medical licensure preferred.

Candidates should have a combination of clinical experience and industry experience as follows:

Clinical experience in treating patients in the specialty or sub-specialtyassociated with the applicants training(comparable to 2 years) and one of the following:

Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or

Direct experience in safety/Pharmacovigilance (comparable to 2 years).

Knowledge, Skills and Abilities:

Therapeutic expertise across one or more medical specialty or sub-specialties

Strong decision-making, problem solving, organizational skills and analytical skills

Excellent oral and written communication skills

Working knowledge of relevant safety databases (e.g. Medra)

Flexibility to travel domestically and internationally

Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information

Proficiency in basic computer applications

Fluent in spoken and written English

Excellent interpersonal, influencing and team building skills

Understanding guidelines (FDA, ICH, EMA and GCP)

Working knowledge of biostatistics, data management, andclinical operations procedures

Ability to act as a mentor/trainer to other staff within PVG PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group. Education and Experience:

MD or equivalent required. Active medical licensure preferred.

Candidates should have a combination of clinical experience and industry experience as follows:

Clinical experience in treating patients in the specialty or sub-specialtyassociated with the applicants training(comparable to 2 years) and one of the following:

Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or

Direct experience in safety/Pharmacovigilance (comparable to 2 years).

Knowledge, Skills and Abilities:

Therapeutic expertise across one or more medical specialty or sub-specialties

Strong decision-making, problem solving, organizational skills and analytical skills

Excellent oral and written communication skills

Working knowledge of relevant safety databases (e.g. Medra)

Flexibility to travel domestically and internationally

Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information

Proficiency in basic computer applications

Fluent in spoken and written English

Excellent interpersonal, influencing and team building skills

Understanding guidelines (FDA, ICH, EMA and GCP)

Working knowledge of biostatistics, data management, andclinical operations procedures

Ability to act as a mentor/trainer to other staff within PVG PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group. Submission for the position: Neurology Medical Director - Contract Opening - Functional Service Partnership - (Job Number: 184063)