The Study Director, Research Scientist will have a passion for preclinical research. The Preclinical Study Director represents the single point of control for assigned studies and following confirmation of appropriate education, training and experience. Study Directors are responsible for the interpretation, analysis, documentation, and reporting of study results for GLP and non-GLP studies.What you will do here:Overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control Performs functions in accordance with GLPs and other applicable regulations and/or guidance'sConsults with Sponsor, Study Directors, and others during protocol development to optimize protocol design to appropriately address study objectivesWorks with the appropriate individuals to design and approve the study protocolResponds to inquiries from clients and other relevant parties regarding scientific aspects of studies. Actively participates in client discussions regarding studiesCoordinates the schedule and logistics of the study with clients, sub-contractors, and relevant internal departmentsConfirms with management that study personnel have the training and education to perform their assigned functionAssures that current copies of approved protocol and amendments are available to all study personnel and SponsorsPrepares the Project Review Form and obtains approval of the study by the IACUCMonitors, tracks, and communicates study milestones throughout departmentsAssures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded, and verified. Assures that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur and that corrective action is taken and documented.Analyzes and interprets study data and prepares study reportsAssures that Sponsors are appropriately informed of ongoing study activities and results and of any corrective actions required. Confirms that all raw data, documentation, protocol, specimens, and study reports are transferred to the archives during or at the close of the studyReviews, revises, and writes SOPs, as necessary Other duties may be assigned as neededWhat you will need to succeed:Masters or Doctoral Degree or equivalent degree in a relevant scientific discipline. A Baccalaureate or equivalent degree and relevant experience may substitute for the education requirements for this positionThree years' experience as a Study Director for in vivo studies (including GLP) in a biopharmaceutical company or Contract Research Organization (CRO) One to two years' experience in Toxicology a plusIntermediate to Advanced Computer SkillsAbility to effectively communicate scientific data interpretation and conclusionsAbility to utilize and interpret appropriate mathematical and statistical methods for analysis of scientific study data Ability to multi-task and maintain organization in a fast paced, rapidly changing environment Ability to manage change Demonstrated expertise in a scientific disciplineStrong planning and organizational skills Ability to work effectively and cooperatively in a team environment under significant time pressureDemonstrated attention to detail and consistent ability to operate with accuracy and qualityProven presentation and facilitation skillsMust complete Study Director Training, training on applicable procedures and SOPsContinuing scientific and/or professional education in areas of scientific and regulatory expertiseWhat We Offer: The pay range estimated for this position is $74,0000 to $110,000 per year. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. BenefitsAltasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.Altasciences' Benefits Package Includes:Health/Dental/Vision Insurance Plans401(k)/RRSP with Employer MatchPaid Vacation and HolidaysPaid Sick and Bereavement LeaveEmployee Assistance & Telehealth ProgramsAltasciences' Incentive Programs Include:Training & Development ProgramsEmployee Referral Bonus Program #LI-BK1
