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.

Essential 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.

Supervision/Decision Making Responsibilities:

• Works 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:

• 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.