Senior Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific and writing assistance for clinical strategy, clinical trial formulation, data analysis and visualization, as well as clinical data dissemination.

• Conduct thorough reviews of documents intended for both internal and external audiences.

• Engage with regulatory and commercial teams, key opinion leaders (KOLs), physicians, and clinical personnel.

• Aid in the development of evidence and strategies for clinical research.

• Design study options and clinical endpoints to enhance decision-making processes.

• Utilize relevant literature and information sources to back clinical endpoint selection, performance targets, and methods for collecting endpoint data.

• Work alongside Clinical Affairs to evaluate the financial and timeline implications of clinical trial options.

• Facilitate the successful execution of clinical trials, including the review of trial materials and providing ad hoc scientific assistance.

• Independently contribute to the clinical sections of Clinical Evaluation Reports.

• Perform literature searches and maintain an up-to-date literature library.

• Write, format, and submit scientific publications.

• Create visual data representations, charts, posters, and presentations.

• Coordinate submissions to scientific conferences and other platforms.

• Assist with KOL interactions, advisory board meetings, medical conferences, and other events.

• Keep abreast of scientific and clinical knowledge in relevant therapeutic areas.

• Participate in the design of Investigator-Initiated Trials (IIT).

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, engineering, statistics, or a related field is required.

• An advanced degree (MS, PhD, MD) is preferred.

• At least 12 years of experience in clinical research with a focus on managing clinical science/research activities.

• Experience in the medical device industry is required.

• Prior experience with oncology clinical trials is preferred.

• Proven experience in authoring and reviewing clinical documents.

• Familiarity with GCP, ICH, and FDA guidelines and regulations for clinical trials.

• Comfortable analyzing data and preparing summaries tailored to specific audiences.

• Proficiency in standard statistical software packages such as SAS, R, SPSS, or MiniTab is preferred.

• Strong analytical abilities in interpreting and understanding scientific research and literature.

• Adequate technical knowledge and understanding of disease areas to engage confidently with both internal and external partners.

• Exceptional writing and presentation skills.

• Capability to manage multiple projects simultaneously.

• Strong organizational, prioritization, and time management skills.

• Ability to work independently and efficiently while paying attention to detail.

• Must be eligible to work in the United States.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Short- and long-term disability protection.

• 401(k) plan.

• Flexible paid time off.