Director/Associate Director, Project Toxicologist, Immune Safety

Director/Associate Director, Project Toxicologist, Immune safety

Location: Gaithersburg (MD), Gothenburg (SE) or Boston (MA).
 

At AstraZeneca, it is our bold ambition to achieve disease modification, clinical remission, and cure, to impact the lives of millions of people worldwide suffering from immune-mediated diseases. We are now expanding our diverse immunology pipeline to secure leadership in numerous immunology indications.

We are looking for a motivated and passionate individual to join us as a Director/Associate Director, Project Toxicologist, Immune Safety with a focus on enabling the delivery of transformative and safe immunology drugs to patients suffering from Immunological diseases. You will provide non-clinical safety expertise for our diverse immunology discovery portfolio containing a broad range of drug modalities. You will play an integral role in driving progression and acceleration of drug projects through drug development programs by designing innovative regulatory toxicology strategies to address drug target- and modality-related risks. The position will be based at one of our vibrant strategic R&D sites in Gaithersburg (MD), Gothenburg (SE) or Boston (MA).
 

Within AstraZeneca we place a strong emphasis on talent development. You will be able to develop your knowledge and skills by working together with experts and leaders in Immunology R&D, safety science, pharmacology, toxicology, drug discovery and development, imaging, pathology, and translational science.
 

What you will do

As an Associate Director/Director, Project Toxicologist in Immune Safety at AstraZeneca, your main accountabilities will be:

• As a core member of multi-disciplinary immunology drug development teams, you will design, deliver, and interpret innovative toxicology strategies to predict, assess and mitigate target- and modality related safety risks.

• Develop and implement innovative solutions to combine regulatory toxicology with groundbreaking science and technologies to progress novel drug candidates to the clinic and through development to the market, in line with business needs.

• To influence project strategy and decision making, you will communicate clear positions on integrated risk assessments in various formats including informing internal decision-making governance bodies and interacting with external health authorities.

• Delivering quality nonclinical summaries and contribute to regulatory submissions for immunology projects of various modalities.

• Maintain expertise in regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends.

• Additional responsibilities include to provide experienced nonclinical evaluation of in-licensing and out-licensing opportunities and to provide mentorship and guidance to emerging toxicologists with respect to the regulatory environment and support their career growth and development in this field.
   

Requirements for this role

• DABT or PhD in toxicology or immunology (or equivalent) with several years of experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead, supporting immunology and/or immuno-Oncology programs with planning, execution, interpretation and communication of regulatory toxicology data.

• A proven understanding of drug development and a track record of delivering multiple toxicology programs to IND and through clinical development.

• High level of knowledge and expertise in designing toxicology strategies and delivering in vitro/in vivo and risk assessment of immune related risks / adverse events, driven by mechanism and/or immunological therapeutics.

• Expertise in immunology, including B- and T-cell biology.

• Ability to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to coordinate tasks across multiple projects.

• Excellent verbal and written communication-, interpersonal- and influencing skills. Adopting an inclusive and collegiate working style, and a desire to drive own- and support others development. Represent AstraZeneca interests, maintaining high ethical and scientific standards.

• Level of the role (Director / Associate Director) will be based on experience, understanding of drug discovery and development, and track record of successful contributions to progression of drug projects and scientific accomplishment.
   

Desirable in the role

• Experience with various modalities (small molecules, protacs, and biologics including bispecific immunomodulatory drugs)

• In addition to possessing scientific competence, we value individuals who can contribute to