For nearly 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work e perform. In return, we’ll help you build a career that you can feel passionate about.
Serve as a scientist in the conduct of assigned nonclinical 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Function independently as a study director in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research.
- Participate in the proposal management and bid development process, serving as a key scientific contact for new business generated from established business relationships.
- Participate in and coordinate all phases of the study planning process with appropriate departments.
- Design preclinical studies, generate high-quality protocols, amendments, reports, and develop appropriate changes to study design for assigned projects and programs.
- 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.
- Provide oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation. Provide scientific expertise in study conduct, design, and interpretation.
- Review reports for peers.
- Provide technical and scientific guidance to the research staff.
- Attend scientific meetings, conferences, and training courses to enhance job and professional skills. Present abstracts/posters at national meetings, when appropriate, to maintain a scientific presence and visibility in areas of individual expertise.
- May supervise research and/or scientific staff, as appropriate for scope of responsibilities.
- May direct activities of assigned group(s) to ensure effective performance of function.
- Interview and select qualified exempt-level departmental personnel. Recommend, review, and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
- Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.
- 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 testing facility management duties for the site as delegated by PCS senior management.
- 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 PhD/DVM 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: Certification as appropriate for specialty preferred.
- Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all types of studies. 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® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
About Safety Assessment
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 120 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.
With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016.