Project Toxicologist, Associate Director – Oncology Targeted Delivery Safety Science

Project Toxicologist, Associate Director – Oncology Targeted Delivery Safety Science

Introduction to role

At AstraZeneca, we are driven by a bold ambition to eliminate cancer as a cause of death, supported by our innovative pipeline aimed at delivering groundbreaking treatment options for patients. Our Oncology Targeted Delivery (OTD) Safety team plays a crucial role in this mission by advancing expert non-clinical safety science. We are seeking a motivated and passionate individual to join us as an Associate Director, Project Toxicologist, OTD Safety. In this role, you will contribute to the development of novel targeted oncology medicines, including Radio Conjugates, Antibody Drug Conjugates, and Small Molecules. We are particularly interested in candidates with experience in radio conjugates but welcome applications from those with expertise in other modality types. Collaborating with scientists across our Oncology R&D organization, you will focus on bridging the gap between discovery and regulatory toxicology teams, developing strategies to address drug target- and modality-related safety risks, driving drug development programs forward, and enhancing our safety science to inform the design and selection of novel drug candidates. This position will be based at one of our vibrant R&D sites in either the Boston Area, MA or Gaithersburg, MD (Washington DC area).

Accountabilities

• As a core member of the project toxicology team, you will design regulatory and investigative toxicology studies and devise strategies to predict, assess, and mitigate target- and modality-related safety risks on project teams, focusing on Radio Conjugates, Antibody-Drug Conjugates, or Small Molecules.

• Apply your toxicology knowledge to predict clinical safety risks and inform decision-making in drug discovery and development programs.

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

• Communicate clear positions on integrated risk assessments in various formats, including informing decision-making governance bodies and contributing to regulatory submissions.

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

• Provide specialist non-clinical safety expertise for evaluation of in-licensing opportunities.

• Develop Oncology Safety science through collaborative networks across AstraZeneca R&D, external collaborations, publications, etc.

Essential Skills/Experience

• Excellent scientist with a PhD and/or DABT in Toxicology, Pharmacology, Oncology or related field, a strong scientific track record, and a willingness to challenge conventional thinking. 3-5 years

• Experience working as a Project Toxicologist, Investigative Toxicologist or similar safety-focused role within the pharmaceutical/biotech/CRO project environment.

• A proven understanding of drug discovery and development and track record of delivering toxicology programs to enable progression of candidates into the clinic.

• Expertise in Oncology, and preferably a solid understanding of drug safety aspects of Radio Conjugates or ADCs.

• Experience delivering non-clinical toxicology studies in support of IND applications.

• Experience with the use of in vitro, in silico and in vivo approaches to predict clinical risks; familiarity with organ-on-chip, imaging and omics for mechanistic insight.

• A collaborative, team-oriented approach, able to solve problems in a goal-focused fashion with capacity to coordinate tasks across multiple projects.

• Able to work independently and deliver toxicology risk assessments in drug development.

• Excellent communication, presentation, interpersonal and influencing skills across levels/subject areas with a strong desire to drive personal development

• Experience and desire to work with teams across geographies including awareness of inclusion and diversity. Adopting a working style that is inclusive and collegiate.

Desirable Skills/Experience

Why AstraZeneca?

AstraZeneca is where science meets data to develop bold solutions that make a tangible difference. We challenge the status quo by digging deep into data using cutting-edge methodologies to drive scientific breakthroughs. Our high-exposure roles allow us to shape deliverables while embracing global opportunities across all Therapy Areas. With a restless need for improvement, we foster an inspiring learning envi