Scientist, Study Director

Your New Company!

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 Scientist, Study Director 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.
• 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.
• 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.
• 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.

What We Offer:

The pay range estimated for this position is $74,000 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.

Altasciences 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 Plans.
• 401(k)/RRSP with Employer Match.
• Paid Vacation and Holidays.
• Paid Sick and Bereavement Leave.
• Employee Assistance & Telehealth Programs.

Altasciences' Incentive Programs Include:

• Training & Development Programs.
• Employee Referral Bonus Program.

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!