Medical Director - Principle Investigator

Job description

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Office Job Description Join Us a 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. Day to day responsibilities: The Medical Director of our Integrated Phase I - IV clinic 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). Serve as the line manager for all Principal Investigators and Sub-Investigators across Phase I–IV clinical studies, providing leadership, performance management, mentoring, and professional development. Maintain overall medical oversight and accountability for the safe conduct of all clinical research activities within the clinic, ensuring the protection of study participants and the prompt identification, assessment, and escalation of patient safety concerns. Ensure the quality, integrity, and reliability of clinical trial data through oversight of clinical conduct, protocol compliance, source documentation practices, and adherence to Good Clinical Practice (GCP) standards. Provide strategic oversight to ensure studies are conducted in accordance with applicable regulatory requirements, ethics committee approvals, sponsor expectations, company SOPs, and relevant local and international regulations. Partner with operational and clinical teams to ensure delivery of study objectives, including enrolment, retention, database quality, timeline milestones, and other key performance indicators agreed with sponsors and clients. Act as the senior medical authority for the clinic, supporting risk management, inspection readiness, audit responses, and continuous quality improvement initiatives across all phases of clinical research. Clinical Trial Support: 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. 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. Education and Experience Requirements: MD or equivalent required. Active Medical Licensure. Board certification in Internal Medicine and clinical experience in treating patients in Internal Medicine required. Candidates should have at least one of the following: Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a Principal Investigator Direct experience in Safety/Pharmacovigilance 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. Knowledge, Skills, Abilities: Therapeutic expertise across one or more Internal Medicine sub-specialties Strong decision-making, problem solving, organizational skills and analytical skills Excellent oral and written communication skills Working knowledge of relevant safety databases 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 (SUKL, EMA, ICH-GCP, FDA, EMA) Working knowledge of biostatistics, data management, and clinical operations procedures Working Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Why join us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.