Overview (Associate) Medical Director Pulmonology, EMEA at Thermo Fisher Scientific. Join to apply for the (Associate) Medical Director Pulmonology, EMEA role at Thermo Fisher Scientific .
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. Our work spans laboratory, digital and decentralized clinical trial services, and we provide our teams with the resources needed to achieve individual career goals while advancing life-changing therapies.
Discover Impactful Work: The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.
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 as 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
Qualifications Education
MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Pulmonology patients in hospital practice
Knowledge, Skills, Abilities
Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
Fluent in spoken and written English
Understanding and experience with NDA submission process
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. We are an equal opportunity employer. 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.
Apply today! http://jobs.thermofisher.com
Seniority level Not Applicable
Employment type Full-time
Job function Research and Science
Industries Pharmaceutical Manufacturing and Biotechnology Research
Madrid, Community of Madrid, Spain
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