Medical Director
Há 1 mês
Lead Clinical Development
As a Medical Director at Thermo Fisher Scientific, you will provide strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This includes the design, development, and execution of Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations.
A Day in the Life:
- Provide medical content and leadership of clinical studies
- Establish and approve scientific methods underlying the design and implementation of clinical protocols
- Ensure study subject safety and regularly review adverse event, laboratory, and other clinical data
- Collaborate with the study executive and independent safety committee as needed
- Represent clinical research through membership on trial teams
Key Responsibilities:
- Contribute to, review, and approve study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and other clinical documents
- Interpret, summarize, and document clinical data for regulatory documents, manuscripts, and other publications
About Thermo Fisher Scientific:
At Thermo Fisher Scientific, we enable 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.
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