Clinical Affairs Scientist

🔥 3 hours ago

🏄 California, District of Columbia, +3 more states – Remote

🏄 California – Remote 🏛️ District of Columbia – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote

💵 $105.3k - $197.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

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Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

💰 $500M Post-IPO Debt on 2019-09

Food & Beverage • Healthcare • Consulting

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• Support clinical evidence generation with cross-functional teams during co-development of oncology companion diagnostics • Support clinical trial study designs and execution, regulatory applications, and scientific marketing deliverables • Provide thought leadership on relevant clinical topics for strategy development and execution • Generate content for external validation studies, including study design and authoring study protocols and reports • Contribute to cutoff/cutpoint determination, 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, and in-stream data monitoring in clinical trials • Ensure scientific validity of reported results through statistical analysis, tabulation, and data presentation • Collaborate with regulatory and development teams on submissions, including clinical performance information and Instructions for Use (IFU) documentation • Provide clinical and scientific oversight of local marketing and commercial materials • Prepare, revise, and maintain standard operating procedures for compliant clinical study conduct • Serve as clinical science subject matter expert in internal, pharmaceutical partner, and regulatory meetings • Author manuscripts, abstracts, whitepapers, and oral/poster presentations • Support audits and inspections as a clinical subject matter expert • Report to the Manager of Clinical Affairs Sciences; no direct reports

🎯 Requirements

• 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 • Ability to manage multiple projects in a fast-paced environment with changing priorities • Ability to work and make independent decisions, understand complex scientific and clinical data information, and take 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

🏖️ Benefits

• Bonus eligibility • Stock eligibility • Benefits • Option to work remotely