Research Scientist II

Job description

For 75 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 we perform.

In return, we'll help you build a career that you can feel passionate about.

**Job Summary**
A Study Director (SD) is responsible for overseeing study conduct of preclinical toxicokinetic/pharmacokinetic and toxicology studies; overseeing protocols/study plans; generation of IACUC protocols, coordinating with technical teams for execution of studies (internally and externally), including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording, and reporting, and verifying that client expectations are met.

The individual in this role independently interprets preclinical toxicity studies, evaluates and prepares data tables, data summaries, and reports from data collected during these studies.

The Study Director communicates with sponsor monitors and representatives, initiates contact with potential clients, and interacts with CRL business development and client services.

May be involved with development of new technologies/procedures and may be required to manage departmental and procedural projects.

Essential Duties and Responsibilities:
* Function as an independent SD, working in a fast-paced environment on multiple studies/programs of moderate to difficult complexity.

See detailed role and responsibilities of Study Director below:
o Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities.
o Oversee, coordinate, and manage study execution including:
* Knowledge of formulations, clinical pathology, necropsy, biomarkers, histology, digital pathology, and bioanalysis.
o Verify that projects are performed according to the protocol and SOPs and excursions from study plan are addressed in a timely manner with the sponsor and internal teams.
o Write, review, and edit draft or final reports that document data and results in summary or condensed report format.
o Communicate with sponsors and CRL study support partners on study related business.
* Host client visits and telephone/video conferences; may assist with or lead facility tours with sponsors.
* Mentor less experienced staff and assist with training of research scientists and scientific coordinators.
* Provides advice to clients and technical teams; provide technical and scientific advice to research staff.
* Assist with proposal development and management under the supervision of Sr. Scientist/Scientific Manager.
* Develop expertise in other areas of speciality, such as specialized endpoints/study types.
* Assist with design, development, and/or performance of new procedures.
* May prepare abstracts for scientific publication, present collaborative or independent research internally or externally.
* Function as departmental representative for interdepartmental communications and initiatives as required.
* Possesses the qualities to solve problems, be a self-starter, build networks, lead through support and lead by example.
* Other duties as assigned.

**Job Qualifications**

+ Bachelor's/Master's/PhD/PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline; with 5 or more years of related industry experience.

Meets expectations related to essential duties and responsibilities of Research Scientist 1.

May represent an entry level for individual with relevant PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline.
+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
+ Success in this role requires familiarity with: study/project costs and impact of changes, local and international regulations and GLPs as they relate to primary area of focus, study process from proposal to report, quality assurance (QA)/quality control (QC) processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients in a manner that generates confidence and builds trust, and communication with technical supervisor and Scientific Manager on issues of overall project costs and its importance related to staffing and equipment issues.
+ Demonstrated ability to anticipate and recognize potential problems within programs and effectively communicate alternatives to internal and external clients and a meaningful fashion.
+ Strong communications skills, verbally and in writing at all levels inside and outside the organization.
+ Basic familiarity with Microsoft Office Suite.
+ Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
+ Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
+ Ability to work under specific time constraints.
+ Ability to provide guidance to internal teams with potentially limited external data.

**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 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.

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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

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.

**Equal Employment Opportunity**

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com.

This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

230117

Required Skill Profession

Other General