Medical Director - Pulmonology (Client - dedicated), EMEA

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking an Associate Medical Director to provide medical leadership for clinical trials and safety evaluation within a client environment.

You will support protocol development, real-time medical monitoring, and collaboration with cross-functional teams to ensure compliant, ethical, and scientifically rigorous studies. Fluent English and a Medical Doctor degree with Pulmonology are required.

Qualifications

• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine.
• Fluent in spoken and written English.
• Shown understanding of NDA submission process.
• Shown understanding of regulatory guidelines for adverse event reporting.

Responsabilités

• Provide medical leadership to study teams, including protocol creation and approvals for trials.
• Real-time medical monitoring of studies to ensure safety and validity of endpoints.
• Coordinate with sponsor and internal departments during all study phases; educate sites.
• Act as medical point of contact for investigators, IRBs, and Health Authorities; support safety reviews.

Connaissances

Pharma industry experience

Clinical trials

English fluency

Regulatory knowledge

Communication skills

Presentation skills

Formation

Medical Doctor with Pulmonology

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate 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.

Discover Impactful Work:

The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within our client environment.

A day in the Life:

• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials

• Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead

• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions’ dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, handles and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries

• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications

• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP

• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties

Education

• Medical Doctor, with a specialty in Pulmonology, shown clinical experience running Pneumonology` patients in hospital practice

• Industry experience in clinical development required (1-2 years)

Knowledge, Skills, Abilities

• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important

• Fluent in spoken and written English

• Shown understanding and experience with NDA submission process.

• Shown understanding of regulatory guidelines for adverse event reporting

• Strong communication & presentation skills and is a strong teammate

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.