Clinical Development Scientist-Strategy

Clinical Development Scientist-Strategy

Requirements

• Master’s degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical or relevant biomedical science fields. Advanced Degree preferred.
• 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.

Responsibilities

• Determine clinical strategy for Agilent’s in-vitro diagnostic devices.
• Scoping and forecasting clinical support of proposed and current projects.
• Manages and oversees the governance, for internal and external stakeholders (Agilent and external laboratory sites, respectively).
• Lead clinical strategic initiatives such as scoping and forecasting clinical efforts on upcoming projects and coordinating Medical Affairs and Clinical Affairs publication strategy.
• 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.

Preferred Qualifications

• Knowledge in oncology and/or pathology preferred.