Senior Scientist–Immunology, Clinical Research
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.
- 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.
- 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.