Senior Director, Nonclinical Toxicology

Location : Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to role

Are you a seasoned toxicologist and veterinary pathologist with a passion for drug development, particularly in gene therapies? Join our dynamic team at Alexion to manage toxicology programs that evaluate compounds in our innovative pipeline. As the lead pathologist and peer reviewer for the Nonclinical Toxicology Group, you will play a crucial role in advancing our mission. This position requires an independent professional who thrives in a fast-paced, ever-changing environment. You will design and manage multiple toxicology studies across various species, exclusively conducted at contract research organizations (CROs). Your expertise in regulatory guidance and report filing with US and European agencies will be essential.

Accountabilities

1. Serve as Toxicology Lead on Alexion Project Teams, providing toxicology expertise and program nonclinical toxicology strategy for a wide range of projects including small molecule, biologic / large molecule, oligonucleotides, gene therapy, and others as applicable.
2. Provide strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, EMEA, GLP procedures, GMP-related compound requirements).
3. Design and execute Toxicology protocols to support the evaluation of Alexion compounds in GLP and non-GLP models of safety in multiple species at external Contract Research Organizations.
4. Provide mentorship and supervision of Pathology Peer Reviews as conducted by other Alexion pathology staff.
5. CRO selection, negotiations, and management are critical responsibilities of the Senior Director, who must manage selection of potential CROs through knowledge gained in consultation with professional colleagues and a critical examination of CRO capabilities.
6. Monitor the performance of Toxicology studies onsite at Contract Research Organizations utilized by Alexion, and conduct Pathology Peer Reviews in a GLP-compliant environment as needed.
7. Provides analysis and interpretation of toxicology and pathology data in preparation for final reports. Prepares or assists in the preparation of documents, final study or technical reports, and annual investigational new drug and new drug application reports.
8. Prepares toxicology / nonclinical safety component of regulatory documents for filing with regulatory authorities in collaboration with the Regulatory Team.
9. Works as part of a multidisciplinary team to support the conduct of pre-clinical studies for Alexion projects in the early discovery phase.
10. Provides support in research projects with multidisciplinary teams such as genomics, molecular biology, toxicology, and pathology to bring discovery candidates into development.
11. Serves as Toxicology Team lead on due diligence and business development activities.
12. Provides complete toxicology risk assessments for CMC related issues, involving a close collaborative relationship with Manufacturing.
13. May provide support to build and maintain technical databases, archives, and department procedures manuals.
14. Post registration; consult as required on issues that arise for marketed compounds.
15. Travel commitment of 10-20%.

Minimum Requirements

1. 8-10 years’ experience in the pharmaceutical business, preferably with gene therapy experience.
2. Experience in development of toxicology study packages to ensure compliance with regulations.
3. Experience designing and managing studies at contract research organizations.
4. Experience in performing GLP-compliant Pathology Peer Reviews.
5. Experience in writing and interpreting toxicology data, including the development of final reports.
6. Boarded Pathologist or equivalent.
7. Excellent written and verbal communication skills.
8. Prefer experience in drug development of gene therapy modality.

At Alexion, we offer a unique career path where you can enjoy the entrepreneurial spirit of a leading biotech while benefiting from the security of a global pharma. Our commitment to the highest standards ensures we protect our patients, people, and planet. We support your career growth by encouraging ownership, skill development, and expanding your capabilities.

Ready to make a difference? 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.