Serve as scientist in the conduct of assigned nonclinical and clinical research studies at all levels of complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as a primary scientific contact for key clients and the on-site support of their programs, as well as the support of specialty studies.
- Function independently as a study director in the direction and execution of assigned studies in compliance with GLP or other applicable regulations for the conduct of nonclinical and clinical research. Cell therapy/Gene Therapy experience is required.
- Participate in the proposal management and bid development process, serving as a key scientific contact.
- Participate in and coordinate all phases of the study planning process with appropriate departments.
- Generate high-quality protocols, amendments, and reports appropriate for assigned studies.
- Independently review, interpret, integrate, and present data on assigned studies.
- Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting. Participate in Sponsor visits.
- Execute the completion of laboratory investigations, assay troubleshooting and quality observations. Understand compliance expectations in order to respond to audit findings.
- Mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation.
- Review reports for peers as needed.
- Provide technical and scientific guidance to the research staff.
- Attend scientific meetings, conferences and training courses to enhance job and professional skills.
- Perform testing facility management duties for the site as delegated by senior management.
- Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state of the art practices.
- Perform all other related duties as assigned.
- Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or Ph.D. preferred.
- Experience: Minimum of 9 to 12 years related experience in the contract research, academic, or pharmaceutical industry.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft(R) Excel, Word, Powerpoint, etc. and with standard laboratory calculations.
- This position may require occasional travel.
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
Nearest Major Market: Chicago
Job Segment: Research Scientist, Pharmaceutical, Biology, Molecular Biology, Senior Scientist, Science