Sr Research Scientist - Clinical/Regulatory - Tobacco

Battelle Memorial Institute   •  

Baltimore, MD

Industry: Government & Non-Profit

  •  

11 - 15 years

Posted 111 days ago

This job is no longer available.

Battelle is guided by a founding mission. We invest our knowledge, talents and resources, helping our customers achieve their most important goals. We apply scientific rigor and creativity, succeeding where others may fail, and we invest in our communities, making the world better for generations to come. All of us share a common purpose: to solve the greatest challenges of today and tomorrow.

Our 22,000 employees work at the forefront of scientific innovation to tackle critical challenges in security, human health, manufacturing, energy and environmental management. Battelle’s work is grounded in the belief that science, technology and a passion for excellence can make industries more competitive and the world a better place.

Primary Function

We are currently seeking a Sr. Research Scientist – Clinical/Regulatory. This position is located in Baltimore, MD.

Battelle’s Health Business Line, Commercial office, offers a staff of highly trained scientists and technicians, and state of the art facilities to support our clients’ clinical, consulting, and regulatory science programs. Our multidisciplinary integrated approach to providing critical solutions for our nicotine and tobacco clients increases the speed of the development while maintaining quality and compliance.

The incumbent will design and conduct studies, interpret data, prepare reports using standard scientific principles, theories, concepts, and techniques per Good Clinical Practice and other clinical regulatory guidelines. Applicant shall exhibit ingenuity, creativity and resourcefulness in the application and/or development of significantly advanced technologies, scientific principles, theories and concepts. The incumbent will act independently to expose and resolve problems associated with the development and implementation of programs. The incumbent will also serve as consultant to management in long-range planning pertaining to new or projected areas of technological advancements.

Major Responsibilities

  • Serve as the Principle Investigator within clinical area
  • Lead proposal development efforts
  • Plan and lead highly complex and advanced technical projects and develop sound experimental techniques for scientific studies
  • Design and manage clinical research as a Study Director/Principal Investigator under Good Clinical Practice (GCP) guidelines
  • Perform data analysis and prepare, review and/or approve highly complex reports
  • Communicate findings to clients and scientific audiences, through both oral presentations and written reports and manuscripts
  • Train and mentor junior technical staff in technical interpretation of complex data, and ensure the technical procedures used for testing/research within the group are current and valid
  • Prepare cost and schedule estimates on proposed projects
  • Provide competent technical advice to management
  • Interface with inter-departmental scientists, data collection technicians and clients for smooth project completion

Major Responsibilities

Position Requirements

THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:

  • PhD in a relevant health-related discipline such as social sciences, behavioral sciences, biological sciences, nursing, education, public health or medicine and 5-8 years of relevant experience, OR
  • Master's degree in a relevant health-related discipline such as social sciences, behavioral sciences, biological sciences, nursing, education, public health or medicine and 8-10 years of relevant experience OR
  • Bachelor’s degree in a relevant health-related discipline such as social sciences, behavioral sciences, biological sciences, nursing, education, public health or medicine and 10 – 15 years of relevant experience
  • At least 5 years’ experience in conducting, managing, planning/reviewing/evaluating clinical research studies in tobacco and nicotine.
  • Working knowledge of Good Clinical Practice (GCP) and other clinical regulatory guidelines
  • Experience in managing or serving in a key role on complex multi-year programs
  • Experience in producing high quality technical reports and/or publications in the area of tobacco and nicotine.
  • Must have excellent written and oral communication
  • Ability and willingness to serve in cross functional roles as needed to ensure business continuity
  • Ability and willingness to market Battelle capabilities

    THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:

  • Regulatory experience
  • Experience working in a CRO or similar industry environment AND/OR experience working in a governmental agency