Medical Director/Sr Medical Director - Neurology(Remote U.S)

Thermo Fisher Scientific • Morrisville, NC

1d • Remote

About The Position

Join Us as a 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.
• Candidates should have at least one of the following: Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years). Ie Neurology Residency/Fellowship
• 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).
• For Senior Medical Director: MD or equivalent required.
• For Senior Medical Director: 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: Ie Neurology Residency/Fellowship 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 across one or more medical specialty or sub-specialties
• 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 within PV

Nice To Haves

• Active medical licensure preferred.

Responsibilities

• Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• Ensure tasks delegated to PV are properly executed.
• Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Follow client SOPs/directives and project-specific WPDs for assigned projects.
• Comply with CRG’s corporate policies and SOPs/WPDs.
• Provide medical consultation to team members and answer all study-related medical questions.
• Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provide therapeutic training and protocol training on assigned studies, as requested.
• Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete.
• Monitor 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.
• Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study.
• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
• Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns.
• 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.

Benefits

• Resources needed to achieve individual career goals
• Collaboration and development environment
• Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree