Medical Director/Sr Medical Director - Pulmonary

Thermo Fisher Scientific•Morrisville, NC

2d•Onsite

About The Position

Join us as a Medical Director/Sr Medical Director – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. 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. 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). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Requirements

MD or equivalent required.
Active medical licensure preferred but not required.
Candidates should have 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.
Candidates should have a combination of clinical experience and industry experience as follows: Candidates should have clinical experience in Pulmonary/Critical Care and formal training (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)
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
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).

Nice To Haves

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.

Responsibilities

Manage 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.
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.