Medical Director
hace 1 mes
At Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. As a Medical Director, you'll play a critical role in bringing our Mission to life by enabling our customers to make the world healthier, cleaner, and safer.
Key Responsibilities:
- Provide strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
- Design, develop, and execute Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations.
- Lead and contribute to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives, and the documentation of study results.
- Act as a clinical/medical representative in meetings with external stakeholders, partners, and other external audiences as needed.
A Day in the Life:
- Provide medical content and leadership of the clinical studies.
- Medical Monitoring of clinical studies.
- Establish and approve scientific methods underlying the design and implementation of clinical protocols.
- Ensure study subject safety.
- Regularly review adverse event, laboratory, and other clinical data, ensuring reporting is done on a timely basis.
- Collaborate with the study executive and independent safety committee when needed.
- Represent clinical research through membership on trial teams.
- 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 as required for the conduct of clinical trials.
- Interpret, summarize, and document clinical data for regulatory documents (INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
- Collaborate with leading academic medical centers.
- Recruit, guide, and motivate clinical investigators.
- Ensure study compliance by understanding and applying all relevant SOPs and GCPs.
- Participate in long-range strategic planning.
Requirements:
- MD degree with specialization in Psychiatry/Neurology is mandatory.
- Drug Development experience in the area of Psychiatry/Neurology.
- Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.
What We Offer:
- Opportunity to work with a global leader in the life sciences industry.
- Collaborative and dynamic work environment.
- Professional development opportunities.
- Competitive compensation and benefits package.
We're committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. Join us in making a meaningful impact on the world.
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