Principal/Associate Director, Toxicologist

Responsibilities

• Work with radioconjugate (RC) and/or gene therapy project teams and clinical pharmacologists to plan development strategies, covering toxicological aspects to enable clinical studies and including
  • Designing preclinical toxicology studies for investigator-initiated trials in China and for international Ph1 trials.
  • Being responsible for developing experimental protocols for preclinical DMPK and toxicology evaluations, communicating and coordinating with CROs and other business units, monitoring the progress of experiments to ensure timely access to information and data, and delivery of analyses and documentation.
  • Drafting and reviewing preclinical study reports and ensuring that summary reports accurately and comprehensively reflect the data and experiments.
  • Sharing mechanistic insights into toxicology and clinical safety findings with clinical pharmacologists, pharmacometricians, and other team members to support PK-PD data analyses.
• Work with project teams to author the toxicology parts of regulatory submission dossiers (IND/NDA, etc.).
• Share relevant external scientific papers with colleagues and participate in research activities for professional growth.

Education, Qualifications, Skills and Experience

Essential

• Ph.D. in toxicology, pharmacology, radiology, or other related disciplines
• Diplomat of certified toxicologist by Chinese Society of Toxicology (中国毒理学会毒理学资格认证, or DCST)
• Familiarity with toxicology related guidance of major health authorities (CDE, FDA and EMA) and ICH
• Knowledge of preclinical pharmacology, toxicology and DMPK related to RCs and/or gene therapy; Adequate understanding of related disciplines (e.g., preclinical pharmacology, DMPK, toxicology, medical, regulatory) in drug discovery
• Working knowledge and experience with GLP studies including nonclinical safety toxicology, particularly in radioconjugates
• Proficient English listening, speaking, reading, and writing skills
• Proven track records and skills in designing, analysing, and reporting toxicology studies and successfully supporting at least 1 IND filing package of RCs in China
• Be able to drive collaborations within the group and across functions

Desirable

• At least 5 years of relevant industry experience in toxicologist role
• Diplomate of the American Board of Toxicology (DABT) or European Register of Toxicologists (ERT) preferrable
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
• Strong network with Health Authority, including but not limited to CDE, FDA, and EMA.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.