Translational Clinical Scientist

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. We are seeking a Translational Clinical Scientist to work on-site with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Bethesda, MD. This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Paid leave, paid federal holidays, and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS (1) Work with Principal Investigators in the designing, development, drafting, and implementation of clinical protocols for evaluation of Vaccine Research Center investigational vaccine and monoclonal antibody products.

• 2) Evaluate and validate biomarkers or other translational endpoints to inform clinical trial design and monitor investigational product efficacy and safety.
• 3) Identify gaps in preclinical data, make recommendations about future studies, and ensure data collection plans are consistent with applicable regulatory requirements and the protocol objectives.
• 4) Design, write and develop documents related to the use of investigational products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, and preparing or editing scientific summaries, presentations and publications.
• 5) Prepare and review regulatory documents for IND submissions, annual reports, safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types.
• 6) Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff.
• 7) Collaborate with cross-functional teams (including laboratory scientists, clinicians, regulatory personnel) to ensure seamless transition of candidate products into clinical trials.
• 8) Serve as a scientific liaison between laboratory research and clinical operations; assist with the dissemination of information about vaccine, monoclonal antibody and other clinical trials
• 9) Assist with quality management activities by reviewing and developing policies and procedures and providing support to risk assessment and clinical monitoring activities.

KEY REQUIREMENTS (1) Ph.D. in Biological Sciences, Biochemistry, Immunology, or related discipline; master’s degree and relevant experience may also be considered

• 2) Minimum of three (3) years of laboratory-based translational or clinical science experience focused on vaccines, monoclonal antibodies, and other investigational products
• 3) Knowledge of and scientific background to inform the design of human clinical trials protocols for investigational products including analytical skills to identify and resolve potential problems related to clinical research and regulatory activities or protocol requirements
• 4) Experience to review, collect, assess, and summarize scientific and other complex data and information related to the development of investigational products as part of the design of clinical trial protocols
• 5) Excellent oral and written communication skills, technical writing skills and organizational skills as applied to scientific and clinical teams engaged in the development of new investigational vaccines, monoclonal antibodies or related product types.

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