Note: The job is a remote job and is open to candidates in USA. Agilent Technologies is seeking an experienced Clinical Affairs Scientist to join its global Clinical Affairs team within the Organization of the Chief Medical Officer. The role supports clinical evidence generation, companion diagnostic co-development in oncology, clinical trial design and execution, regulatory submissions, and scientific marketing deliverables while collaborating with pharmaceutical partners and cross-functional teams.
Responsibilities
- Provide thought leadership on key relevant clinical topics to support strategy development and execution
- Generation of content to support external validation studies including study design and authoring of study protocols and reports. May also contribute to cutoff/cutpoint determination studies, method comparison, bridging, and analytical concordance studies
- 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 such as Instructions for Use (IFU)
- 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 as well as 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
Skills
- * Master's degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical or relevant biomedical science fields
- * 4+ years of experience in IVD product development, clinical research, medical writing, and/or clinical science in the medical device and/or pharmaceutical industry
- * Familiarity with clinical trial design, conduct, and oversight including biostatistics, and Good Clinical Practice preferred
- * 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, immunology, and/or pathology preferred
- Advanced Degree preferred
- * Familiarity with clinical trial design, conduct, and oversight including biostatistics, and Good Clinical Practice preferred
- * Knowledge in oncology, immunology, and/or pathology preferred
Benefits
- Eligibility for bonus
- Eligibility for stock
- Eligibility for benefits
- Option to work remotely
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