OverviewAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We enable our customers to make the world healthier, cleaner and safer through research, development and delivery of life-changing therapies. Our work spans laboratory, digital and decentralized clinical trial services across 100+ countries.Discover Impactful WorkThe (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.A Day in the LifeProvide medical leadership to the study teams, including creating clinical trial protocols, contributing to site selection, review and approval of study protocols and amendments, CSRs, ICFs, 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 primary endpoints and subject safety; identify medical issues early and address them in consultation with the Global Medical Indication Lead.Review protocol items with internal groups regarding procedural and budgetary needs; coordinate with other functions to close gaps and address issues in a timely and effective manner. Serve as chief liaison between sponsor and all PPD/ Thermo Fisher Scientific internal departments across all study phases. Educate sites with protocol-specific lab procedures during investigator meetings. Manage day-to-day activities to resolve issues and respond to queries.Serve as medical point of contact for internal and external stakeholders: interact with investigators, respond to IRBs and Health Authorities, prepare and present material to study executives and safety committees as applicable; provide medical training at investigator meetings and for CRAs in new indications.Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP.Collaborate with cross-functional study team members to ensure medical risks, issues, and results are clear to all involved parties.EducationMD, MBBS or equivalent degree with strong medical knowledge; clinical experience managing Neurology patients in hospital practice.Knowledge, Skills, AbilitiesSignificant experience within the pharmaceutical industry, clinical trials and pharmaceutical medicine.Fluent in spoken and written English.Understanding and experience with NDA submission process.Understanding of regulatory guidelines for adverse event reporting.Strong communication and presentation skills; effective team player.Mission and ApplyOur mission is to enable our customers to make the world healthier, cleaner and safer. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Job SummaryJob number: R-01281651Date posted: 2025-01-08Profession: Clinical ResearchEmployment type: Full time
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