Job Overview

Provide direct oversight of scientific and operational processes for discovery through regulated (GLP) and clinical bioanalytical services. Manage assigned scientific staff and provide scientific direction, operational oversight, and provide mentorship for junior staff. Develop and maintain strong client/sponsor relationships and participate in business development activities. Additional responsibilities include serving as the subject matter expert and primary scientific contact for internal and external clients and the on-site support of their programs, as well as ensuring the regulatory compliance of laboratory procedures, documentation, and data management.

Job Description• Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training, and development of employees.• Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong.• Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics.• Operate as a subject matter expert to provide leadership, expert consultation and mentorship to cross-functional company teams.• Collaborate and consult with prospective Sponsors, providing scientific expertise and developing ongoing Sponsor relationships. Assist with providing costing estimates for components of applicable studies.• Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs.• Effectively plan, assign and direct work within one or more operational areas.• Maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas.• Provide leadership for the robust development of novel methods within one or more operational areas, demonstrating proficiency with lab skills and understanding of scientific and regulatory concepts in experimental design.• Establish and maintain best practices and processes for training, mentoring and transition of developed methods.• Skillfully oversee the design, conduct, interpretation and reporting of studies as needed.• Demonstrate effective communication skills through both formal and informal collaboration and discussions with peers, supervisor, team, cross-site, and externally with collaborators and sponsors.• Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements as needed.• Review and approve Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures.• Maintain contemporaneous knowledge of regulatory requirements.

Required Education and Experience• Education: PhD or international equivalent in a science related field required.• Experience: 10 or more years' experience in the contract research or pharmaceutical industry conducting scientific research. Experience in a GLP (discovery) environment required. Management experience required. Experience with financial business planning and project management experience preferred.• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.• Other:• Excellent verbal and written communication, and organizational skills.• Demonstrated independent analytical and problem-solving abilities.• Demonstrated proficiency in managing a laboratory area.• Demonstrated knowledge and full understanding of GLP regulatory requirements and industry standards.• Ability to develop and maintain client/sponsor relationships and direct client/Sponsor programs.• Ability to interact appropriately with all levels of employees.• Ability to work effectively as a member of a team.• Ability to work in a dynamic, detailed driven environment.• Ability to apply leadership, negotiation, interpersonal, and managerial skills.• Ability to oversee multiple projects, prioritize work and meet deadlines.• Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.• This position may require occasional travel.

WORKPLACE REQUIREMENTS: • While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

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 20,000 employees within 110 facilities in over 20 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.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.