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At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.

About the role The Study Director, 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's 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 needed

What 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 position

One to two years’ experience in Toxicology, specifically at a preclinical CRO, is 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

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

Must complete Study Director Training, training on applicable procedures and SOPs

Continuing scientific and/or professional education in areas of scientific and regulatory expertise

120 Altasciences Preclinical Seattle LLC

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Study Director, Scientist