Non-clinical Manager

Alexion Pharmaceuticals; Lyon; Hybride; EUR 60 000 - 95 000; Plein temps

Résumé du poste

Ein innovatives Unternehmen im Bereich der biopharmazeutischen Forschung sucht einen Non-Clinical Manager, der eine Schlüsselrolle im präklinischen Team spielt. In dieser spannenden Position bringen Sie Ihre wissenschaftliche und technische Expertise ein, um die Entwicklung lebensverändernder Medikamente voranzutreiben. Sie arbeiten eng mit globalen Projektteams und externen Partnern zusammen, um sicherzustellen, dass alle Studien den höchsten Qualitätsstandards entsprechen. Wenn Sie eine Leidenschaft für Wissenschaft und einen Wunsch haben, einen Unterschied im Leben von Patienten zu machen, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• 3-5 Jahre Erfahrung als Toxikologie-Studienleiter in Pharma oder Biotech.
• Experte in der Verwaltung nichtklinischer Studien und GLP.

Responsabilités

• Überwachung des Designs und der Durchführung nichtklinischer Studien.
• Zusammenarbeit mit CROs zur Sicherstellung der Studienqualität.

Connaissances

Toxikologie

Projektmanagement

Kommunikationsfähigkeiten

Analytische Fähigkeiten

Formation

PharmD oder VetD

Master in Biologie oder verwandten Bereichen

Description du poste

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.

Date Posted

20-Jan-2025

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.