Careers

CCSA seeks talented, qualified employees in all of our operations. CCSA offers a full benefits package (medical, dental, vision, long-term health), AD&D, life insurance, and 401k plan. CCSA is an Equal Employment Opportunity Employer.

For consideration, send resume, cover letter, and formal writing sample (where requested) to careers@ccsainc.com.*

Senior Scientist – Immunology, Clinical Research

Summary

Senior Scientist – Immunology, Clinical Research is a non-laboratory position for scientist with immunology background; responsibilities include technical and scientific tasks in support of our consulting contracts; development and management of projects within a technical program; serving as scientific resource and pharmaceutical agent and/or medical device expert; and interaction with clients.

Duties and Responsibilities

  • Serves as pharmaceutical/biologics agent and/or medical device (imaging, molecular profiling) expert; surveys literature and reviews client reports to stay current on agent/device.
  • Prepares documents for clients, such as manuscripts/reports, Clinical Development Plans, Investigational New Drug (IND) applications and other regulatory submissions, Investigator’s Brochures, and protocol reviews.
  • Prepares documentation requiring knowledge of pharmacology, pharmacokinetics, toxicology, or other specialized areas, for clients and regulatory authorities.
  • Contributes to design of databases of scientific and drug development information.
  • As appropriate, contributes to biomarker research.
  • Interacts with government and/or commercial clients and may develop new business.
  • Facilitates scientific meetings and programs as requested by clients.
  • Contributes to new client contract proposals.
  • Develops and manages projects in area of scientific expertise.
  • Develops necessary regulatory expertise, proposes regulatory strategies, and participates in response to FDA comments.
  • Work independently and may develop own projects.
  • May supervise project area and staff.

Qualifications

  • Strong background in immunology, including experience with the development of therapeutic immune modulators, immune-oncology, and/or vaccines.
  • Excellent written and oral communication skills; publications in peer-reviewed biomedical journals.
  • Experience managing scientific projects and working in a team environment.
  • Extensive scientific and technical background in biomedical sciences; skill in data analysis.
  • Ability to work effectively without supervision.
  • Biochemist, molecular biologist, or toxicologist with drug development experience and/or expertise in animal and clinical pharmacokinetics and pharmacodynamics, with emphasis on immunology-based programs.

Education and Work Experience

  • PhD, DVM, or MD.
  • Two or more years relevant post-graduate experience in pharmaceutical or biotechnology industry, contract research organization, government or private research institute, or academia.
  • Scientific training and expertise in immunology in areas relevant to program, such as pharmacology, molecular biology, toxicology, medicinal chemistry; experience in drug development preferred.
*Note: Incomplete applications (e.g., missing cover letter and/or writing sample) will not be considered. For the formal writing sample, if part of a multi-author publication, please explain what your contribution was.