Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

Director, Nonclinical Toxicology

Reports to:

Head, Nonclinical Toxicology

Location:

Barcelona

Position Summary

An experienced toxicologist to manage toxicology programs designed to evaluate compounds in the Alexion pipeline. 

An ability to work independently in a fast paced, dynamic and changing environment is essential. 

Design and management of multiple simultaneous toxicology studies in rodents, non-rodents (e.g. dogs and rabbits) and non-human primates is required. Studies will be conducted exclusively at contract research organizations, and experience in managing CRO vendor relationships is essential.

Must have working knowledge of key regulatory guidance documents and the filing of reports with regulatory agencies in the US, Europe, and Japan (in collaboration with key regulatory personnel), and experience in writing and submission of regulatory documents. Support for processes related to compound registration is also essential.

The Director will manage every aspect of the study process, including budget, execution and troubleshooting, data analysis, and report writing.

Membership and effective contributions to multidisciplinary project teams is required. As required, the Director may be a member of or make presentations to senior level management committees such as RSC, FIH and/or DCSC. 

The Director will also be responsible for participation on multiple business diligence/due diligence and external collaborations, experience in evaluating business development opportunities from safety and nonclinical perspective is highly preferred.

Principal Responsibilities

  • Serve as Toxicology Lead on Alexion Project Teams, provide toxicology expertise for wide range of projects including small molecule, biologic, mRNA therapeutics and other modalities.
  • 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
  • CRO selection, negotiations and management are critical responsibilities of the director. The director must manage selection of potential CROs through knowledge often gained in consultation with professional colleagues and a critical examination of CRO capabilities. To this end the Director will collaborate with Alexion procurement staff. 
  • Monitor the performance of Toxicology studies onsite at Contract Research Organizations utilized by Alexion.
  • Provides analysis and interpretation of toxicology 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 manipulation and techniques.
  • 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 and SOPs.
  • Post registration/life cycle management; consult as required on issues that arise for marked 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 5-10% is required along with periodic trips between sites.

Qualifications

  • 5-10 years’ experience in the pharmaceutical or device business, preferably with biologics and/or small molecules.
  • Experience in development of toxicology study package to ensure compliance with regulations.
  • Experience designing and managing studies at contract research organizations.
  • Writing and interpreting toxicology data, including the development of final reports
  • Exposure to bioanalytical procedures and sample evaluation
  • Experience in preparing toxicological risk assessments
  • 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
  • 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

Education

  • DABT preferred, but not required
  • BS or MS in Toxicology or related field

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

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 lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.

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Confirmed 22 hours ago. Posted 30+ days ago.

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