Work Schedule

Standard (Mon-Fri)

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 – To enable 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.

Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Summarised Purpose for the Medical Director-Investigator

Serves as the investigator on all assigned clinical trials providing medical oversight for a particular protocol and client. Ensures that the protocol is being conducted under all applicable laws, regulations and per ICH-GCP guidelines in the organization's Clinical Research Unit (CRU). Consults with clients and provides scientific and medical insight for protocols. Researches compounds being considered by the CRU for subject safety. Evaluates and signs off on medical data collected, completed case report forms (CRFs) and final clinical study reports (CSRs). Build and maintains strategic relationships with clients and partners with operational and business development staff. Liaises with senior level management to provide medical guidance and oversight at the CRU.

Essential Functions:

Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.Reviews and establishes protocols for scientific, logistical and safety feasibility, as requested.Ensures adherence to client directives and study protocols for assigned projects.Performs role as described in FDA Form 1572, including, but not limited to informed consent and screening examinations of subjects, clinical management of safety issues for the individual subjects as well as the study cohort.Presents all first-in-human and other high risk trials to the Human Safety Committee (HSC) to ensure those trials are thoroughly reviewed and approved by the voting members. Provides expertise and leadership in the development of risk management plan(s) (RMP) with the Project Manager to mitigate any risk to subject safety for all studies.Provides or oversees training on assigned studies, as requested.Provides consultation on medical concerns with medical monitors (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, as appropriate, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.Provides medical consultation to team members and answers study related medical questions. Communicates with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Deviates from current approved study protocol only if it is in the medical emergent safety needs of a subject.Leads the monitoring, evaluation and action plan as needed on safety variables (adverse events, laboratory/ECG abnormalities, changes in subject medical status and un-blinding requests) during a clinical trial.Assesses reported adverse events and determines causality and study drug relationship. Assesses and determines the clinical significance of out of range laboratory values and other observed abnormalities noted within safety assessments.Develops and implements departmental process improvement initiatives.Trains and supervises more junior team members.Attends senior level leadership meetings and partners to drive strategic department initiatives.

Knowledge, Skills and Abilities: 

Education and Experience:

MD or equivalent required. Active medical licensure preferred.Acquired Specialty examMembership in the Czech Medical ChamberCandidates should have a combination of clinical experience and industry experience as follows:Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training(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

Knowledge, Skills and Abilities:

In-depth knowledge of important regulatory considerations and experience with national and/or international regulatory authoritiesProven ability to assess the safety and tolerability of different classes of drugsThorough knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studiesAbility to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solveExceptional analytical abilityDemonstrated ability to exercise discretion and sound judgementSuperb decision-making, negotiation and influencing skillsExcellent communication skills and English and Czech language fluencyExcellent organizational skills and detail-orientated leadership approachProficiency in basic computer applicationsAbility to work in a team environment

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.