Clinical Affairs Scientist

3 weeks ago

Washington, Washington, D.C., United States Agilent Full time
Job Summary

We are seeking a highly experienced Clinical Affairs Scientist to join our team in the medical diagnostic field. The ideal candidate will have a strong background in clinical science and research, with experience working in pharmaceutical, biomarker, and/or in vitro diagnostic clinical development. The successful candidate will support clinical evidence generation, study designs, and execution, as well as regulatory applications and scientific marketing deliverables.

Key Responsibilities
  • Provide thought leadership on key clinical topics to support strategy development and execution.
  • Generate content to support external validation studies, including study design and authoring of study protocols and reports.
  • Design and develop databases, Electronic Data Capture (EDC) systems, and case report forms.
  • Contribute to risk analyses, study quality control activities, and instream data monitoring in clinical trials.
  • Ensure scientific validity of reported results, including statistical analysis, tabulation, and presentation of data.
  • Collaborate with regulatory and development teams during the submission process, including authoring of clinical performance information and other documentation.
  • Provide clinical and scientific oversight of local marketing and commercial materials.
  • Ensure effective, efficient, and compliant Clinical Affairs processes, including preparing, revising, and maintaining standard operating procedures for the conduct of clinical studies.
  • Serve as the clinical science subject matter expert in cross-functional internal meetings and meetings with pharmaceutical partners and regulatory bodies.
  • Author manuscripts, abstracts, whitepapers, and prepare oral/poster presentations.
  • Support audits and inspections as a clinical subject matter expert.

Qualifications
  • Master's degree or advanced degree in pharmaceutical, medical, or relevant biomedical science fields.
  • 4+ years of experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry.
  • Familiarity with clinical trial design, conduct, and oversight, including biostatistics, and Good Clinical Practice.
  • Ability to interpret regulatory standards, guidance, and laws.
  • Strong scientific, medical writing, and presentation skills.
  • Exceptional ability to manage multiple projects in a fast-paced environment with changing priorities.
  • Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.
  • Experience working with external partners and/or regulatory bodies, including the FDA.
  • Knowledge in oncology and/or pathology preferred.

Additional Details
This is a full-time position with a weekly schedule. The job includes the option to work remotely. Applications for this job will be accepted until at least October 15, 2024, or until the job is no longer posted. The full-time equivalent pay range for this position is $97,000 - $180,000, plus eligibility for bonus, stock, and benefits.

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