(Senior) Medical Director - Rheumatology (Client - dedicated), EMEA

(Senior) Medical Director - Rheumatology (Client - dedicated), EMEA

Join to apply for the (Senior) Medical Director - Rheumatology (Client - dedicated), EMEA role at Thermo Fisher Scientific.

Overview

At Thermo Fisher Scientific, you’ll work to enable our mission: making the world healthier, cleaner and safer. Our teams contribute to clinical trials, pharmacovigilance and research and development to deliver life-changing therapies across 100+ countries.

Work Schedule : Standard (Mon-Fri)

Environmental Conditions : Office

Role Purpose

The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.

Responsibilities

• Provide medical leadership to study teams, including creating clinical trial protocols, reviewing and approving study documents (CSRs, ICFs, CRFs, protocol deviations), contributing to site selection and protocol amendments as required.
• Real-time medical monitoring of clinical studies: ensure medical validity of primary endpoints and subject safety; identify medical issues early and advise on corrective actions in collaboration with the Global Medical Indication Lead.
• Coordinate protocol reviews with internal groups, address procedural and budget considerations, and liaise between sponsor and internal Thermo Fisher/PPC teams across all study phases. Educate sites through protocol-specific training during investigator meetings.
• Serve as medical point of contact for internal and external stakeholders; respond to IRB/Health Authority inquiries, prepare material for executives and safety committees when applicable; train site staff and CRAs on new indications.
• Ensure study compliance for all medical aspects by applying SOPs and GCP guidelines.
• Collaborate with cross-functional study teams to clearly communicate medical risks, issues and results to all involved parties.

Qualifications

Education

• MD, MBBS or equivalent degree with clinical experience managing Rheumatology patients in hospital practice.

Knowledge, Skills & Abilities

• Significant experience within the pharmaceutical industry, clinical trials and pharmaceutical medicine.
• Fluent in spoken and written English.
• Experience with NDA submission process and regulatory guidelines for adverse event reporting.
• Strong communication and presentation skills and the ability to work well in a team.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. We value integrity, intensity, innovation and involvement across a global team.

Apply today at Thermo Fisher Scientific. Thermo Fisher 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.