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 fastpaced everchanging 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 GMPrelated compound requirements).

• Design and execute Toxicology protocols to support the evaluation of Alexion compounds in GLP and nonGLP 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 GLPcompliant 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 pathologyspecific 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 preclinical 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 1020

Essential Skills/Experience

• 810 years experience in the pharmaceutical business preferably with gene therapy experience

• Experience in development of toxicology study package to ensure compliance with regulations.

• Experience designing and managing studies at contract research organizations.

• Experience in performing GLPcompliant Pathology Peer Reviews experience in reading histopathology slides for internal discovery research work model development.

• Experience in various stains histopathology techniques as needed to support program development.

• Writing and interpreting toxicology data including the development of final reports

• Exposure to bioanalytic procedures and sample evaluation

• Experience in preparing toxicological risk assessments.

• Boarded Pathologist or equivalent.

• Integration of veterinary pathology and toxicology skills in the performance of toxicology studies in 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 technique helpful

• Exposure to key principles of lab animal and vivarium management helpful

• Excellent written and verbal communication skills

• Experience working within a matrix working environment and a displayed willingness to support global initiatives that influence the working environment at Alexion in a positive way (e.g. participation in multidisciplinary workstreams

• 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!

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 EVerify.