Research Scientist, Study Director
About The Role
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'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
- 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