Senior Scientist and Group Leader, Clinical Research

Senior Scientist and Group Leader, Clinical Research is a non-laboratory position with basic responsibilities including technical and scientific tasks in support of CCS Associates consulting contracts; development and management of projects within a technical program; supervision of technical and scientific staff with the group; serves as scientific resource and pharmaceutical agent and/or medical device expert; provides nonclinical and clinical guidance and project management; and interacts with clients.

Responsibilities

• Serves as subject matter expert in pharmacology, pharmacokinetics, or toxicology to support and advise on nonclinical development of consulting contracts.
• Provides scientific oversight for IND submissions, working with agent project managers on nonclinical and clinical rationale, content, and organization.
• Provides project management support for IND submissions.
• Provides scientific oversight and review of preclinical and clinical information and document requests from government and/or commercial clients.
• Supervises scientific staff responsible for generation of regulatory documents; supervises additional scientific staff contributing to regulatory submissions.
• Develops necessary regulatory expertise, proposes regulatory strategies, and participates in response to FDA comments.
• Serves as pharmaceutical/biologics agent and/or medical device (imaging, molecular profiling) expert; survey literature and review 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.
• Contributes to design of databases of scientific and drug development information.
• 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
• Works independently and may develop own projects.
• Supervises project area and staff.

Qualifications

• Excellent written and oral communication skills; publications in peer-reviewed biomedical journals.
• Experience managing scientific projects and working in a team environment.
• Experience mentoring and managing technical and scientific staff.
• Extensive scientific and technical background in biomedical sciences; skill in data analysis.
• Ability to work effectively without supervision.
• Toxicologist, biochemist, or molecular biologist with drug development experience and expertise in animal and clinical pharmacokinetics and pharmacodynamics.
• Located near enough to San Jose, California or Tysons Corner, Virginia to work in CCSA offices at least 2 days/week, and preferably 3–5 days/week.

Education and Experience

• PhD, DVM, or MD.
• Ten 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 areas relevant to program, such as pharmacology, toxicology, medicinal chemistry, molecular biology, along with experience in drug development.

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