Non-Clinical Toxicology Manager

Location: Mississauga, ON (hybrid 3x a week)

Introduction to the role

Join us at Alexion, AstraZeneca's Rare Disease division, as a Non-Clinical Manager. You will be a key member of the non-clinical team in this role. You will collaborate with the global project team, regulatory affairs, and clinical team as an expert in early drug development. Your key accountabilities will be to support our programs, bringing your scientific and technical expertise to the teams to ensure the success of preclinical development programs. The right candidate will be a critical thinker that brings technical expertise and enthusiasm for the company along with a deep scientific knowledge. In collaboration with our partners (CROs), you will oversee the design, implementation, management and reporting of pre-clinical studies: pharmacokinetics, general toxicology, reproduction toxicology, genotoxicity, carcinogenicity, safety pharmacology.

What you’ll do:

• Assist in selecting partners to conduct studies with regards to the expertise, quality, cost and time aspects,

• Act as the privileged contact with CROs for contracts, invoices, study setup, monitoring, onsite visit and reporting,

• Identify and resolve scientific, technical, logistical or quality issues related to studies,

• Ensure that studies align with regulatory and quality requirements,

• Review, analyze and interpret the data, coordinate report review and finalization with highest quality standards,

• Summarize, communicate and promote results to the project teams and management,

• Coordinate activities with other departments (finances, CMC, bioanalysis, regulatory…),

• Closely monitor technological and regulatory developments in your field of expertise.

Requirements:

• PharmD, VetD, master’s degree in biology, animal sciences, toxicology or related fields, or Bachelors with relevant experience

• Minimum of 3-5 years of experience as a toxicology study director/monitor in pharma, biotech or CRO setting,

• Expertise in management of nonclinical studies, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical studies,

• Ensure successful study execution within allocated budgets and timelines,

• Good interpersonal and communication skills with ability to relate to both internal and external collaborators,

• Good organizational, planning, and project management skills, attention to detail,

• Good English proficiency (written and spoken), as it is a daily working

Annual base salary for this position ranges from 110,999.20 to 145,686.45.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.