Medical Director/Sr Medical Director - Pulmonary

About the role

The 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.

Responsibilities

• Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• 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.
• 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.
• Aids 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.
• Maintains 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.
• Reviews 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.

Requirements

• MD or equivalent required.
• Clinical experience in Pulmonary/Critical Care and formal training (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.
• 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; Direct experience in safety/Pharmacovigilance (comparable to 2 years).

Qualifications

• Therapeutic expertise in Neurology.
• Strong decision-making, problem solving, organizational skills and analytical skills.
• Excellent oral and written communication skills.
• 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.

Skills

• Working knowledge of relevant safety databases (e.g. Medra).
• Ability to act as a mentor/trainer to other staff.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!