21 ago
|
AstraZeneca
|
Barcelona
21 ago
AstraZeneca
Barcelona
Introduction to role:
This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.
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 non-clinical team, working synergistically with the general 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
Accountabilities:
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.
In detail:
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 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.
Coordinate activities with other departments (finances, CMC, bioanalysis, regulatory…).
Closely monitor technological and regulatory developments in your field of expertise.
Essential Skills/Experience:
PharmD, VetD, master’s degree in biology, animal sciences, toxicology or related fields.
Minimum of 3-5 years
📌 Non-Clinical Toxicology Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona