Senior Medical Director

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose

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. labelling reconciliation documents, CTD modules, REMS, RMP and CSR).

General Support

Ensures tasks delegated to pharmacovigilance 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. 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. 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

Marketed Products Support

Manages signal detection activities, scientifically reviews 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 required with specialization in Oncology or Hemato-Oncology (active medical license preferred). Clinical experience in treating patients associated 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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Med Dir and Sr Med Dir requires additional CRO/Pharma industry experience and maybe considered.

Knowledge, Skills and Abilities

Therapeutic expertise across one or more medical specialty or sub-specialties (one being Oncology or Hemato-Oncology)

Excellent interpersonal skills, influencing and team building skills

Understanding of guidelines (FDA, ICH, EMA and GCP)

Working knowledge of biostatistics, data management, and clinical operations procedures

Ability to act as a mentor/trainer to other staff within pharmacovigilance

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

Excellent oral and written communication skills

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

Flexibility to travel domestically and internationally for short periods

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

Proficiency in computer productivity applications (e.g. word processor, spreadsheets and presentations) required

Fluent in spoken and written English

Capable of multitasking and good organization skills