Job Title: Sr Medical Director
Job Location: Alachua, FL
Job Duration: 6 Months (Possibilities of Extension)

Job 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).

Essential Functions:
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
1. 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 Companies 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.

2. 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.

3. 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 or equivalent required.
• Active medical licensure preferred.

Candidates should have at least one of the following:

• Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 3 years).
• Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 3-5 years) in the industry.
• Direct experience in safety/Pharmacovigilance (comparable to 3 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.

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, and clinical operations procedures.
• Ability to act as a mentor/trainer to other staff.

Remote with travel (certain clinical research sites)