Medical Director/Senior Medical Director - Endocrinology(Remote U.S)

About this role

Job Title: Medical Director/Senior Medical Director - Endocrinology(Remote U.S)
Job Location: Cary, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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).

Discover Impactful Work:

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

A day in the Life:

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.

Keys to Success:
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 sufficient for an individual to meet the requirements of the role. Job leveling at Medical Director or Senior Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results.

Knowledge, Skills and Abilities:

• Therapeutic expertise in Neurology

• 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

Physical Requirements / Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment

• Occasional drives…