Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Medical Director – Principal Investigator

Physicians & SurgeonsConfirmed live in the last 24 hours

Full-timePrague, CzechiaNo salary listed

About the Job

Requirements

An MD and an active medical license to practice in the Czech Republic are required.
Board certification in Internal Medicine in the Czech Republic is required.
Proficiency in Czech is required.
Therapeutic expertise across one or more Internal Medicine subspecialties is required.
Strong decision-making, problem-solving, organizational, and analytical skills are required.
Excellent oral and written communication skills are required.
Flexibility to travel domestically and internationally is required.
Ability to work independently, analyze work with attention to detail, and process and prioritize sensitive, complex information is required.
Proficiency in basic computer applications is required.
Fluency in spoken and written English is required.
Understanding of SUKL, EMA, ICH-GCP, and FDA guidelines is required.

Responsibilities

Serve as the lead Principal Investigator for clinical studies conducted within the clinic, providing medical oversight and accountability for safe and ethical clinical research and the protection of study participants.
Serve as 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 safe clinical research activities in the clinic, protecting study participants and promptly identifying, assessing, and escalating patient safety concerns.
Ensure clinical trial data quality, integrity, and reliability through oversight of clinical conduct, protocol compliance, source documentation practices, and adherence to Good Clinical Practice standards.
Ensure studies comply with applicable regulatory requirements, ethics committee approvals, sponsor expectations, company standard operating procedures, and relevant local and international regulations.
Partner with operational and clinical teams to deliver study objectives, including enrollment, retention, database quality, timeline milestones, and other sponsor- and client-agreed key performance indicators.
Support risk management, inspection readiness, audit responses, and continuous quality improvement as the clinic's senior medical authority across all phases of clinical research.
Represent the clinic in client and sponsor discussions and contribute medical and operational expertise to assessing opportunities and study feasibility and shaping site strategy for successful delivery.
Monitor study safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medication protocol restrictions, and unblinding requests.
Participate in medical decision-making on clinical concerns during studies, including interpretation of inclusion and exclusion criteria and assessment of participant safety.
Make appropriate clinical decisions as Principal Investigator for studies under direct oversight and, where appropriate, consult with or provide medical guidance to other Principal Investigators and clients.
Provide medical review of adverse events of special interest, serious adverse events, and clinical outcome events reported by study sites.
Perform data review as specified in client contracts and data validation manuals, 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 solicited, spontaneous, literature, and other sources as contracted.
Attend and present at investigator and sponsor meetings, provide medical consultation to clients, investigators, and project team members, and support business development activities.
Conduct medical review and analysis for clinical-trial serious adverse events, marketed-product individual case safety reports, and periodic safety reports.

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 clinicserves as a Principal Investigator and senior medical authority for the clinic, providingdirectmedical oversight of clinical trials.This rolerequiresaPhysician 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 includesmedical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports) as well as other client deliverables.

Key Responsibilities:

Serve asthe leadPrincipal Investigator for clinical studies conducted within the clinic, providing medical oversight and accountability for the safe and ethical conduct of clinical research and the protection of study participants.

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.

Provide and participate in medical decision-making regarding clinical concerns arising during the course of a study, including interpretation of inclusion/exclusion criteria and assessment of participant safety.

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.

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:

MDand active medical license in Czech Republic required

Board certification in Internal Medicine in Czech Republic

Proficient in Czech Language

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

Flexibility to travel domestically and internationally

Ability to work independently, analyze work with attention to detail, process and prioritize sensitivecomplex 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)

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size: 10,001+
Company stage: IPO
Headquarters: Waltham, MA
Founded: 1956

Recently Posted Jobs

Explore more opportunities at Thermo Fisher Scientific

See more jobs