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 youre a recent college graduate or seeking your next career opportunity its time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

Represents the single point of control for a study and is responsible for the interpretation analysis documentation and reporting of study results.

What Youll Do Here

• Performs functions of a Study Director with a full SD workload including GLP studies.

• Functions as an independent Study Director with 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 Sponsors contributing scientists and other key individuals during Protocol development to optimize Protocol design and appropriately outline 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 and deviations that may affect the quality and integrity of the nonclinical laboratory study are evaluated for their potential impact on the study and communicated to the Sponsor.

• Independently interprets and integrates the study data to prepare high-quality reports with minimal 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 Youll Need to Succeed

• BSc or equivalent degree in toxicology or related field. May have PhD with limited experience

• 6 months-5 years experience with PhD or MSc

• 5-8 years experience with BS

• Previous experience with reproductive toxicology safety pharmacology or metabolic diseases is preferred

• MS Word Excel Outlook and Power Point

• 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.

• Ability to multi-task and maintain organization in a fast paced rapidly changing environment. Ability to manage change. Demonstrated expertise in 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. Ability to successfully operate independently with minimal guidance.

What We Offer

The salary range estimated for this position is $79000 - $120000. Please note that 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

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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!