Medical Director​/Senior Medical Director - Endocrinology; Remote U.S

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Location/Division Specific Information:

Our detailed, goal-oriented Medical colleagues manage the safety profile of new drugs in clinical trials. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.

* Must be legally authorized to work in the United States or Canada without sponsorship.

* Must be able to pass a comprehensive background check, which includes a drug screening(where applicable).

The Medical Director/Senior Medical Director 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, and provides medical review and analysis for clinical trial serious adverse events

General Support:

• Ensures tasks delegated to medical monitors 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.

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:

• Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities.

• Medically review 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 but not required. Candidates should have formal training in either Endocrinology Diabetes & Metabolism (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years).

For Senior Medical Director Level:

• MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience and industry experience as follows:

• Candidates should have formal training in either Endocrinology Diabetes & Metabolism (i.e residency and/or fellowship), along with patient treatment experience (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)

• Preference towards individuals with clinical development/medical monitoring experience

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered…