Work Schedule
Flex Shifts 40 hrs/wk
Environmental Conditions
Office
Job Description
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 serves as a Principal Investigator and senior medical authority for the clinic, providing direct medical oversight of clinical trials. This role requires a Physician who is board-certified in Internal Medicine and holds an active medical license to practice in Czech Republic. You will be responsible for ensuring the safe conduct of clinical studies, the protection of study participants, and compliance with company SOPs, client directives, Good Clinical Practice (GCP), applicable regulatory requirements, and ethical standards.
You will provide medical leadership, attend and present at investigator and sponsor meetings, provide medical consultation to clients, investigators and project team members and supports business development activities.
The role also includes medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports) as well as other client deliverables.
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.
Actively support business development activities by representing the clinic in client and sponsor discussions, contributing medical and operational expertise to the assessment of new opportunities and study feasibility, and helping shape site strategy for successful operational delivery.
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.
As Principal Investigator, make appropriate clinical decisions for studies under your direct oversight and, where appropriate, consult with or provide medical guidance to other Principal Investigators and clients.
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:
Knowledge, Skills, Abilities:
Understanding guidelines (SUKL, EMA, ICH-GCP, FDA, EMA)