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

• Serve as Toxicology Lead on Alexion Project Teams, provide toxicology expertise and program nonclinical toxicology strategy for wide range of projects including small molecule, biologic/large molecule, oligonucleotides, gene therapy and others as applicable.

• 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). 

• 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.

• Provide mentorship and supervision of Pathology Peer Reviews as conducted by other Alexion pathology staff.

• CRO selection, negotiations and management are critical responsibilities of the Senior Director must manage selection of potential CROs through knowledge often gain in consultation with professional colleagues and a critical examination of CRO capabilities.  Developing a monetary relationship with a CRO also requires that the Senior Director has an excellent generic appreciation of price and value.  Such insight will be invaluable for pragmatic negotiations (often simultaneously with multiple CROs).  To this end, the Senior Director will collaborate with Alexion procurement staff. Also, the Senior Director (or rarely a designate) must be available at all times (including weekends and holidays) to manage issues that arise during a study.  Finally, choices that often need to be made regarding animal welfare on a study will require veterinary/pathology expertise and experience. 

• Monitor the performance of Toxicology studies onsite at Contract Research Organizations utilized by Alexion, and in particular conduct Pathology Peer Reviews in a GLP-compliant environment as needed, and provide Pathology Peer Review support and oversight for all GLP toxicology studies conducted in the Nonclinical Toxicology group.  Assist in the development of efficient veterinary and pathology-specific approaches to issues to address clinical events that emerge.

• 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.

• Prepares toxicology/nonclinical safety component of regulatory documents for filing with regulatory authorities in collaboration with Regulatory Team.

• Works as part of a multidisciplinary team to support the conduct of pre-clinical studies for Alexion projects in the early discovery phase.  Such support will be especially helpful in the support of technical support for animal model development, pathology assessment of model development.

• Provides support in research projects with multidisciplinary teams such as genomics, molecular biology, toxicology, and pathology to bring discovery candidates into development. 

• Serves as Toxicology Team lead on due diligence and business development activities.

• Provides complete toxicology risk assessments for CMC related issues.  This responsibility will involve a close collaborative relationship with Manufacturing.

• May provide support to build and maintain technical databases, archives and department procedures manuals.

• Post registration; consult as required on issues that arise for marketed compounds.   As required provide support for documents that often need to be updated on an annual basis.  As required, interact with Pharmacovigilance to provide nonclinical consultative advice regarding observations made in patients.

• Travel commitment of 10-20%

Essential Skills/Experience

• 8-10 years’ e