Study Director, Associate Scientist
Job Description
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
As a Study Director, Associate Scientist, you represent the single point of control for a study and are responsible for the interpretation, analysis, documentation, and reporting of study results with assistance by peers.
What You'll Do Here
Study Director in training:
Learns the overall role and responsibility of the Study Director position conducting nonclinical studies.
Supports the Study Director with the planning and hosting of client visits.
Learns the application of the GLPs and other applicable regulations and/or guidance.
Assists the Study Director in the preparation of the Main report (e.g. drafting/reviewing the results, materials and methods sections), utilizing the appropriate report template.
Post completion of the Study Director training:
Performs functions of a Study Director under the supervision of peers/mentors/manager.
Limited workload starting with non-GLP studies.
Overall responsibility for the technical conduct of assigned studies, 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 as they apply to the conduct of nonclinical studies.
Consults with Sponsor, peers, and other key individuals during protocol development to optimize protocol design to appropriately address study objectives.
Coordinates all phases of a non-clinical study in collaboration with internal departments, external vendors, and clients.
Ensures that current copies of approved protocol and amendments are available to all study personnel and Sponsors.
Obtains approval of the study by the IACUC using the appropriate IACUC submission forms.
Plans and hosts client visits.
Monitors, tracks, and communicates study milestones effectively to all contributors (internal and external), including the Sponsor.
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 with some assistance.
Responds to internal and external Quality Assurance (QA) audits to maintain regulatory compliance.
Assures that Sponsors are appropriately informed of ongoing study activities, results, and any corrective actions (as applicable).
Confirms that all raw data, documentation, protocol, specimens, and study reports are transferred to the archives during or at the close of the study.
What You'll Need to Succeed
BSc or equivalent degree in toxicology or related field
Up to 2 years experience with PhD or Masters
Minimum 2-4 years experience with Bachelors
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.
Excellent verbal and written communication skills.
Well developed interpersonal skills are required.
Personal/professional integrity and proven discretion in handling confidential information.
Ability to develop strong trusting relationships in order to gain support and achieve results.
Capable of managing multiple conflicting priorities.
Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
Relevant industry experience a plus.
What We Offer
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
Telework when applicable.
Altasciences’ Incentive Programs Include:
Training & Development Programs
Employee Referral Bonus Program
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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
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!