Senior Clinical Research Leader Psychiatry/Neurology
hace 4 días
At Thermo Fisher Scientific, we are committed to making the world a healthier, cleaner and safer place. Our team of experts is dedicated to accelerating research, solving complex scientific challenges, and driving technological innovation.
Job DescriptionThis role provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. As a Senior Clinical Research Leader in Psychiatry/Neurology, you will be responsible for designing, developing, and executing Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations.
You will lead and contribute to the analysis of study results, assess the extent to which the study(ies) has achieved clinical/regulatory objectives, and document study results. Additionally, you may act as a clinical/medical representative in meetings with external stakeholders, partners, and other external audiences as needed.
A Day in the Life- Provides medical content and leadership of the clinical studies.
- Medical monitoring of clinical studies.
- Establishes and approves scientific methods underlying the design and implementation of clinical protocols.
- Ensures study subject safety.
- Regularly reviews adverse event, laboratory, and other clinical data, ensuring reporting is done on a timely basis.
- Collaborates with the study executive and independent safety committee when needed.
- Represents clinical research through membership on trial teams.
- Contributes to, reviews, and approves 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.
- Interprets, summarizes, and documents clinical data for regulatory documents (INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
- Collaborates with leading academic medical centers.
- Recruits, guides, and motivates clinical investigators.
- Ensures study compliance by understanding and applying all relevant SOPs and GCPs.
- Participates in long-range strategic planning.
To be successful in this role, you must have a MD degree with specialization in Psychiatry/Neurology. You should also have drug development experience in the area of Psychiatry/Neurology. Desirable qualifications include experience in the therapy areas of Monoclonal Antibodies and/or Translational Medicine.
SalaryThe estimated annual salary for this position is $250,000-$350,000, depending on experience and qualifications.
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