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(Associate) Medical Director - Cardiology, EMEA, Barcelona
Client: Thermo Fisher Scientific
Location: Barcelona, Spain
Job Category: Other
EU work permit required: Yes
Job Views: 3
Posted: 06.03.2025
Expiry Date: 20.04.2025
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.
Discover Impactful Work:
The (Associate) 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:
1. Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information.
2. Contribute to site selection and 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.
3. 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.
4. Proactive customer concern and correction of issues in consultation with the Global Medical Indication Lead.
5. Consult with internal groups during the initial review of the protocol regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments.
6. Serve as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.
7. Educate Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during investigator meetings.
8. Control, handle, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.
9. Act as the medical point of contact for all internal and external stakeholders, interact with investigators, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable, and provide medical training of site staff at Investigator meetings.
10. Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.
11. Closely collaborate with cross-functional study team members to ensure medical risks, issues, and results are clear to all involved parties.
Education:
MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Cardiology patients in hospital practice.
Board certified in Cardiology.
Knowledge, Skills, Abilities:
1. Experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically important.
2. Fluency in spoken and written English.
3. Understanding and experience with NDA submission process.
4. Understanding of regulatory guidelines for adverse event reporting.
5. 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.
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