Medical Director - Investigator Prague, Praha

Medical Director - Investigator

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**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
**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, logístical and safety feasibility, as requested.
- Ensures adherence to client directives and study protocols for assigned projects.
- 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.
- 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 exam
- Membership in the Czech Medical Chamber
- 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 authorities
- Proven ability to assess the safety and tolerability of different classes of drugs
- Thorough knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
- Exceptional analytical ability
- Demonstrated ability to exercise discretion and sound judgement
- Superb decision-making, negotiation and influencing skills
- Excellent communication skills and English and Czech language fluency
- Excellent organizational skills and detail-orientated leadership approach
- Ability 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.

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