Overview Senior) Medical Director - Rheumatology (Client - dedicated), EMEA at Thermo Fisher Scientific. This role involves providing medical leadership and strategic medical input for clinical trials within the Pharmacovigilance department, supporting safety evaluation and cross-functional collaboration across study teams in the EMEA region.
Work Schedule: Standard (Mon-Fri).
Environment Office environment. Our mission is to enable customers to make the world healthier, cleaner and safer. Join a team of 100,000+ colleagues unified by values: Integrity, Intensity, Innovation and Involvement.
Responsibilities Provide medical leadership to study teams, including contributing to protocol development, site selection, review and approval of study protocols and amendments, CSRs, ICFs, CRFs, protocol deviations and other clinical documents related to the conduct of clinical trials.
Perform real-time medical monitoring of clinical studies to ensure medical validity of primary endpoints and subject safety; identify medical issues early and coordinate with the Global Medical Indication Lead to address them.
Engage in initial protocol reviews with internal groups on procedural and budgetary items, ensuring timely changes due to protocol amendments; act as chief liaison between sponsor and Thermo Fisher Scientific internal departments; educate sites via protocol-specific lab procedures during investigator meetings; manage day-to-day trial activities and resolve issues.
Serve as medical point of contact for internal and external stakeholders; interact with investigators, respond to IRB / Health Authority inquiries, prepare and present materials to study executives and safety committees; provide medical training at Investigator meetings and CRA training for new indications.
Ensure study compliance for medical aspects by applying all relevant SOPs and GCP guidelines.
Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are clear to all involved parties.
We would consider candidates for Senior level Medical Director who have experience in strategic development.
Qualifications MD, MB / BS or equivalent degree with strong medical knowledge and clinical Rheumatology experience in hospital practice.
Significant experience within the pharmaceutical industry, clinical trials and pharmaceutical medicine.
Fluent in spoken and written English.
Understanding and experience with NDA submission processes.
Understanding of regulatory guidelines for adverse event reporting.
Strong communication and presentation skills, and ability to work well in a team.
Education MD, MB / BS or equivalent degree; clinical experience managing Rheumatology patients in hospital practice.
Knowledge, Skills, Abilities Extensive pharmaceutical industry experience with clinical trials and pharmaceutical medicine.
Fluent in English (spoken and written).
Experience with NDA submissions and regulatory adverse event reporting guidelines.
Strong communication, presentation, and teamwork abilities.
Apply today as 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.
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