Non-Clinical Toxicology Manager

Alexion; Mississauga; Hybrid; CAD 111,000 - 145,000; Full time

Benefits offered by this job

Vacation: 4 weeks

Personal Days

Equity incentives

Bonus opportunity

Job summary

Alexion, AstraZeneca's Rare Disease division, is seeking a Non-Clinical Manager in Mississauga, ON, offering a hybrid schedule (3 days on site). You will oversee non-clinical programs, collaborate with global teams, CROs, and regulatory groups, and drive preclinical studies in pharmacokinetics, toxicology, and safety pharmacology.

The role requires a PharmD/related degree with 3–5 years' experience, strong GLP knowledge, data interpretation skills, and excellence in project management and

Qualifications

• 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 GLP fundamentals and data interpretation.
• Ability to manage budgets and timelines for studies and communicate results clearly.

Responsibilities

• Assist in selecting partners for studies based on expertise, cost, quality, and timelines.
• Act as primary CRO contact for contracts, invoices, setup, monitoring, onsite visits, and reporting.
• Identify and resolve scientific, technical, or quality issues related to studies.
• Ensure studies meet regulatory and quality requirements.
• Review, analyze and interpret data; coordinate report reviews to high standards.
• Summarize and present results to project teams and management.
• Coordinate activities with Finance, CMC, Bioanalysis, Regulatory teams.
• Track regulatory and technological developments in the field.

Skills

GLP management

Data interpretation

Toxicology

Project management

English proficiency

Education

PharmD or equivalent

Job description

Non-Clinical Toxicology Manager

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

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

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

#LI-Hybrid

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.