Associate Director, Pathologist, Nonclinical Toxicology
Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
Introduction to role:
Are you ready to make a difference in the world of rare diseases? As an Associate Director, Pathologist in Nonclinical Toxicology, you'll lead toxicology programs that evaluate compounds in the Alexion pipeline. Your expertise as a veterinary pathologist and toxicologist will be pivotal in designing and leading pathology aspects across multiple toxicology studies involving rodents, non-rodents, and non-human primates. With studies conducted exclusively at contract research organizations, your experience in handling CRO vendor relationships will be essential. You'll also take the lead on projects as the primary toxicologist, supporting early and global project teams as programs progress. Are you prepared to contribute to multidisciplinary project teams and make presentations to senior management committees?
Accountabilities:
Serve as Toxicology Lead on Alexion Project Teams, providing toxicology expertise and nonclinical toxicology strategy for diverse projects including small molecules, biologics, oligonucleotides, gene therapy, and more.
Provide strategic and operational direction ensuring toxicology studies align with guidelines and regulatory standards (FDA, EMEA, GLP procedures, GMP-related requirements).
Design and implement toxicology protocols to evaluate Alexion compounds in GLP and non-GLP models of safety across multiple species at external Contract Research Organizations.
Perform Pathology Peer Reviews, including digital slide reviews.
Supervise performance of toxicology studies at Contract Research Organizations used by Alexion, conducting Pathology Peer Reviews and providing oversight for all GLP toxicology studies.
Analyze and interpret toxicology and pathology data for final reports; prepare or assist in preparing documents, final study reports, and annual investigational new drug and new drug application reports.
Prepare toxicology/nonclinical safety components of regulatory documents for filing with authorities in collaboration with the Regulatory Team.
Support pre-clinical studies for Alexion projects in early discovery phase, especially in technical support for animal model development and pathology assessment.
Collaborate with multidisciplinary teams such as genomics, molecular biology, toxicology, and pathology to advance discovery candidates into development.
Lead due diligence and business development activities as Toxicology Team lead.
Provide complete toxicology risk assessments for CMC-related issues, collaborating closely with Manufacturing.
Support building and maintaining technical databases, archives, and department procedures manuals.
Post-registration consultation on issues for marketed compounds; interact with Pharmacovigilance for nonclinical consultative advice regarding patient observations.
Essential Skills/Experience:
3-5 years’ experience in the pharmaceutical business
Experience in development of toxicology study package ensuring compliance with regulations
Experience designing and handling studies at contract research organizations
Experience performing Pathology Peer Reviews; reading histopathology slides for internal discovery research work
Experience in various stains and histopathology techniques supporting program development
Writing and interpreting toxicology data, including final report development
Exposure to bio-analytic procedures and sample evaluation
Experience preparing toxicological risk assessments
Boarded Pathologist or equivalent
Integration of veterinary pathology and toxicology skills in performance of toxicology studies across multiple species
Preparation and submission of regulatory documents
CRO monitoring and qualification
Toxicology study and budget management; management of professional personnel
Development of new supportive technologies or toxicological approaches; experience with novel delivery systems and surgical techniques useful
Exposure to key principles of lab animal and vivarium management useful
Excellent written and verbal communication skills
Experience working within a matrix environment; willingness to support global initiatives positively influencing Alexion's working environment
Education:
DVM or equivalent
Diplomate of ACVP or ECVP
Competencies:
Learning on the Fly
Perspective
Command Skills
Process Management
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 AstraZeneca, you'll find a culture that values diversity and different thinking. Here, inclusion is championed so life-changing ideas can emerge from anywhere. Our patient-driven ethos energizes us to build connections that profoundly impact lives. We celebrate each other's successes while taking pride in giving back to our communities. With tailored development programs designed for skill enhancement and fostering empathy towards patient journeys, you'll be empowered to grow alongside exceptional leaders and peers.
Ready to make an impact? Apply now to join our team!
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.