Research Scientist II

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.