Project Toxicologist, Director – Oncology Targeted Delivery; OTD Safety Science, Clinical Phar

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

At AstraZeneca, it is our bold ambition is to eliminate cancer as a cause of death. This is underpinned by our rich pipeline aimed to deliver innovative treatment options for patients. OTD Safety colleagues contribute to this ambition by accelerating innovative and expert non‑clinical safety science.

We are looking to recruit a highly motivated and passionate individual to join us as a Director, Project Toxicologist, OTD Safety to contribute to the development of novel targeted oncology medicines, including Radio Conjugates, Antibody Drug Conjugates and Small Molecules. We are particularly interested to hear from candidates with experience with radio conjugates but also welcome applications from candidates with experience in other modality types.

In collaboration with scientists across our Oncology R&D organization, this role will focus on the interface between the discovery and regulatory toxicology team, 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 will be based at one of our vibrant R&D sites in either Boston Area, MA or Gaithersburg, MD (Washington DC area) (60% onsite hybrid working).

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 Oncology R&D, safety sciences, pharmacology, toxicology, drug discovery and development, imaging, pathology, and translational science.

• As core member of the project toxicology team, you will design regulatory and investigative toxicology studies to 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 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 contribute 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.

• 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.
• Experience working as a Project Toxicologist, Investigative Toxicologist or similar safety focussed role within the pharmaceutical/biotech/CRO project environment with at least 10 years of relevant professional experience.
• 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 for oncology therapeutics; 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…