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 youll 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. Youll 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 Alexions 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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 youll 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 others successes while taking pride in giving back to our communities. With tailored development programs designed for skill enhancement and fostering empathy towards patient journeys youll be empowered to grow alongside exceptional leaders and peers.

Ready to make an impact Apply now to join our team!

Date Posted

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 statuspregnancy (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.