Non-clinical Manager

Non Clinical Manager

Location: Ecully (Lyon), 3 days on site

This is what you will do:

Join us at Alexion, AstraZeneca's Rare Disease division, as a Non-Clinical Manager. In this role, you will be a key component of the pre-clinical team, working synergistically with the global project team, regulatory affairs and clinical team as the expert in early stages of drug development. This role may require working across projects and diseases.

You will be responsible for:

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 a 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… In details:

• Select 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 the studies,
• Ensure that studies comply 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,
• Participate in the writing of non-clinical sections of regulatory documents to support clinical trial application and new drug registration,
• Coordinate activities with other departments (finances, CMC, bioanalysis, regulatory…),
• Closely monitor technological and regulatory developments in your field of expertise.

You will need to have:

• PharmD, VetD, master’s degree in biology, animal sciences, toxicology or related fields,
• 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 stakeholders,
• Good organizational, planning, and project management skills, attention to detail,
• Good English proficiency (written and spoken), as it is a daily working language.

Why us?

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need 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 unique and ambitious world.

At Alexion, AstraZeneca's Rare Disease division, we are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. We champion diversity and inclusion, ensuring kindness remains as important as our ambition to succeed for those in need. We take pride in giving back to the communities in which we operate.

Are you ready to make an impact? To drive change with integrity? To join a culture that celebrates diversity, innovation, and the power of connection to patient’s lived experiences? If so, apply today and join us in our mission to change lives every day.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.