Preclinical Study Director, Toxicology at Altasciences Preclinical Services

Posted in Research 24 days ago.

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Type: Full Time
Location: Everett, Washington





Job Description:

Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Fargo, ND; Kansas City, KS and Seattle, WA. Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

Summary of Job:

Represents the single point of control for a non-GLP study and is responsible for the interpretation, analysis, documentation, and reporting of study results. Will also serve as the single point of control for GLP studies, following confirmation of appropriate education, training and experience. Works closely with the Radiation Biology staff in the support and conduct of respective tasks and duties.

Essential Job Responsibilities:

  • 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 guidances
  • Consults with Sponsor, Study Directors and others during protocol development to optimize protocol design to appropriately address study objectives
  • Works with the appropriate individuals to design and approve the study protocol
  • Responds to inquiries from clients and other relevant parties regarding scientific aspects of studies. Actively participates in client discussions regarding studies
  • Coordinates the schedule and logistics of the study with clients, sub-contractors, and relevant internal departments
  • Confirms with management that study personnel have the training and education to perform their assigned function
  • Assures that current copies of approved protocol and amendments are available to all study personnel and Sponsors
  • Prepares the Project Review Form and obtains approval of the study by the IACUC
  • Plans and hosts client visits
  • Monitors, tracks, and communicates study milestones throughout departments
  • Assures 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 reports; may be assigned to serve as a Contributing Scientist or a Principal Investigator
  • Responds to internal and external Quality Assurance (QA) audits to maintain compliance
  • Assures 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 study
  • Stays informed of current industry practices through research and review of scientific literature and regulatory documents

Requirements:

  • Education: Masters or Doctoral Degree or equivalent degree in a relevant scientific discipline
  • Work Experience: At least five years in a scientific capacity in biomedical research in an academic, industrial, or Contract Research Organization (CRO) environment; experience in scientific leadership preferred
  • Computer Skills: Intermediate to Advanced Computer Skills
  • Language(s) Skill: Verbal and written communication skills in English; the ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents. Ability to effectively communicate scientific data interpretation and conclusions
  • Math Skills: Ability to utilize and interpret appropriate mathematical and statistical methods for analysis of scientific study data
  • Training Requirements: Continual GLP training. Must complete New Study Director Training, training on applicable procedures and SOPs. Continuing scientific and/or professional education in areas of scientific and regulatory expertise. Continuing Study Director Training

Other Requirements:

  • Ability to multi-task and maintain organization in a fast paced, rapidly changing environment
  • Ability to manage change
  • Demonstrated expertise in a scientific discipline
  • Strong planning and organizational skills
  • Ability to work effectively and cooperatively in a team environment under significant time pressure
  • Demonstrated attention to detail and consistent ability to operate with accuracy and quality
  • Proven presentation and facilitation skills
  • Ability to successfully operate independently with minimal guidance
  • Preferred Skills: ability to provide guidance and counsel to prospective clients and staff on complex scientific technical and regulatory issues. Medical, scientific or technical writing

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov.

PI111270008