Senior Medical Director, Medical Monitor
Posted 23 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
As a Senior Medical Director, you will offer medical supervision for clinical research to guarantee strict alignment with organizational and legal guidelines across the drug development journey. You will oversee all medical tasks within your scope, maintaining high standards of compliance with corporate operating procedures and industry-standard clinical practices. By offering direct medical advice to colleagues, clients, and trial investigators, you will resolve clinical inquiries and provide therapeutic education for your assigned projects. You must demonstrate proficiency in drafting and auditing vital materials, such as regulatory filings and clinical reports, to ensure accurate reporting of medical data. Moreover, you will proactively track safety metrics and conduct signal detection to support ongoing safety assessment throughout clinical operations.
Requirements
- You must hold an MD degree or a comparable qualification, with active medical licensure preferred and a proven history of clinical work, ideally in hematology, oncology, or related fields.
- You are required to have experience conducting clinical trials within a pharmaceutical firm or a Contract Research Organization, supplemented by a strong background in drug safety and pharmacovigilance.
- You must possess an extensive understanding of ICH standards and clinical trial laws, as well as an ability to follow specific project instructions and corporate procedures.
- You must demonstrate the capacity to offer expert medical consultations and educate staff on therapeutic standards.
- You need the ability to evaluate safety and efficacy findings within various documents, as well as the medical knowledge to track clinical outcomes and adverse events during research.
Responsibilities
- You will supervise medical activities during clinical trials to verify consistency with organizational protocols and legal regulations.
- You will coordinate with the pharmacovigilance department to ensure safety data is evaluated accurately.
- You will offer medical guidance for project-specific questions and conduct training on therapeutic study designs.
- You will perform detailed examinations of clinical data summaries and documentation related to adverse events to interpret key safety insights.
- You will engage in signal detection work, contribute to the creation of safety summaries, and assist in updating product labeling.
- You will support commercial efforts by attending meetings with sponsors.
- You will collaborate on internal initiatives designed to boost operational productivity.
Benefits & Perks
- This role is performed entirely from a remote location, facilitating a flexible approach to work and personal life.
- You will operate on a typical Monday-to-Friday schedule, designed to balance your professional responsibilities with your personal time.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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