Associate Medical​/Medical Director - Rheumatology

Work Schedule

Standard (Mon-Fri)

Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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

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

The Associate/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.

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)

• 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.

• 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.

• 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.

• MD or equivalent required. Active medical licensure preferred but not required. Candidates should have at least one of the following:

• Formal Rheumatology(allergy/immunology may also be acceptable) or Dermatology residency/fellowship along with Clinical experience in treating patients in the specialty or sub-specialty associated with the applicant's training (comparable to 2 years);
  Or

• 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)

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

• Clinical experience in treating patients in the specialty or sub-specialty 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)

• Experience preference towards individuals with clinical development/medical…