Medical Director, Clinical Trial Physician – Rheumatology

🔥 28 minutes ago

🌲 North Carolina – Remote

infoinfo

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 28 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide medical leadership to study teams • Create clinical trial protocols and implement current scientific information • Contribute to site selection and review or approval of study protocols and amendments • Review Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions, and other clinical documents • Perform real-time medical monitoring of clinical studies • Ensure medical validity of primary endpoints and study subject safety • Identify, escalate, and correct medical issues in consultation with the Global Medical Indication Lead • Interpret clinical trial data for regulatory documents, manuscripts, and publications • Serve as medical point of contact for internal and external stakeholders • Interact with investigators and answer questions from IRBs and Health Authorities • Prepare and present materials to study executive and independent safety committees when applicable • Provide medical training to site staff and CRA training in new indications • Ensure medical compliance with relevant SOPs and GCP • Collaborate with cross-functional study team members on medical risks, issues, and results • Harmonize site/IRB/RA answers, eligibility decisions, and protocol deviation decisions when multiple physicians work on a protocol

🎯 Requirements

• Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including a drug screening • Medical Doctor or equivalent degree required • Board certification(s) preferred • Specialty education (e.g. residency/fellowship) required in rheumatology • Patient treatment and/or research experience in rheumatology • 1-3 years of industry experience preferred, in clinical development within a Pharmaceutical, Biotech, or CRO organization • Excellent English, written and spoken • Ability to travel • Understanding and experience with the NDA submission process • Understanding of regulatory guidelines for adverse event reporting • Interpersonal skills to lead a study team and exercise judgment about escalation • Problem-solving and negotiation skills • Strong communication skills for cross-functional collaboration • Ability to work in a matrix structure, gather decision information, negotiate, and communicate decisions and actions • Ability to access and use in-house and off-the-shelf computer software • Ability to communicate and understand spoken and written information • Ability to work independently, multitask, perform under stress, and maintain regular attendance

🏖️ Benefits

• Benefit eligible • Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits • Career and development prospects • Exciting company culture centered on integrity, intensity, involvement, and innovation

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