Project Toxicologist, Director – Oncology Targeted Delivery (OTD) Safety Science, Clinical Pharmacology and Safety Sciences

Role Summary

Director, Project Toxicologist, OTD Safety to contribute to the development of novel targeted oncology medicines, including Radio Conjugates, Antibody Drug Conjugates and Small Molecules. Role focuses on the interface between discovery and regulatory toxicology, develop regulatory toxicology strategies to address drug target- and modality-related safety risks, drive progression and acceleration of drug development programs, and develop our safety science to inform the design and selection of novel drug candidates. This role is based at one of AstraZeneca's R&D sites in Boston Area, MA or Gaithersburg, MD (Washington DC area), with 60% onsite hybrid working.

Responsibilities

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

Qualifications

• Required: 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.
• Required: Experience working as a Project Toxicologist, Investigative Toxicologist or similar safety-focused role within the pharmaceutical/biotech/CRO project environment with at least 10 years of relevant professional experience.
• Required: A proven understanding of drug discovery and development and a track record of delivering toxicology programs to enable progression of candidates into the clinic.
• Required: Expertise in Oncology, and preferably a solid understanding of drug safety aspects of Radio Conjugates or ADCs.
• Required: Experience delivering non-clinical toxicology studies in support of IND applications.
• Required: Experience with the use of in vitro, in silico and in vivo approaches to predict clinical risks for oncology therapeutics; familiarity with organ-on-chip, imaging and omics for mechanistic insight.
• Required: A collaborative, team-oriented approach, able to solve problems in a goal-focused fashion with capacity to coordinate tasks across multiple projects.
• Required: Able to work independently and deliver toxicology risk assessments in drug development.
• Required: Excellent communication, presentation, interpersonal and influencing skills across levels/subject areas with a strong desire to drive personal development.
• Required: Experience and desire to work with teams across geographies including awareness of inclusion and diversity; adopting an inclusive, collegiate working style.
• Required: Due to the diverse nature of the AstraZeneca Oncology portfolio, opportunities exist for Project Toxicologists to support a range of modalities across various phases of development.