Research Scientist, Study Director

Company: Altasciences
Location: Everett
Posted on: May 12, 2022

Job Description:

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

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.

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 G Ps 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
• 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
• 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
• Reviews, revises, and writes SOPs, as necessary
• Other duties may be assigned as neededQualifications:
  
  • 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 position
  • Three 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 plus
  • Intermediate to Advanced Computer Skills
  • Ability to effectively communicate scientific data interpretation and conclusions
  • Ability 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
  • 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
  • Must complete Study Director Training, training on applicable procedures and SOPs
  • Continuing scientific and/or professional education in areas of scientific and regulatory expertiseAltasciences 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. INDMP

Keywords: Altasciences, Everett , Research Scientist, Study Director, Executive , Everett, Washington