Location: Chengdu, China / Hyderabad, India
We are seeking highly motivated individuals to join nonclinical safety pharmacology and toxicology team of the Chengdu Anticancer Bioscience (ACB) Ltd. The role will be involved in the design, execution, analysis, interpretation, and communication of nonclinical safety studies of small molecules and their associated delivery systems to provide nonclinical safety profile and risk assessment to support drug development. This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical subject matter expert. The appointee will design, conduct, and interpret nonclinical toxicology and investigational safety studies; will advise management on the toxicological aspects of the project. This is an ideal position for an independent individual with a strong background in the discovery and preclinical toxicology and safety pharmacology who enjoys working in a team-oriented and highly cross-disciplinary environment.
· Support our discovery group in the safety testing of lead compounds, including introduction of new testing paradigms.
· Design, supervise, interpret, and report in vitro and in vivo nonclinical toxicology IND-, late-stage clinical trial- and NDA- enabling studies.
· Participate in the management of CROs/academic sites in the conduct of in vitro and in vivo safety studies and in-house toxicology studies.
· Participate in the preparation of preclinical dossiers for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers (e.g. IB, INDs, NDAs) and communications as well as responses to inquiries from regulatory agencies.
· Work closely with internal functional groups such as Pharmacology, ADME-PK, Bioavailability (BA), CMC, Regulatory Affairs, Clinical Development, and Project Management. Actively participate in team strategy discussions for drug development programs.
· Participate in the preparation of abstracts and manuscripts for publication
· DVM or PhD in pharmacology, toxicology, or related scientific discipline.
· Relevant industry experience in toxicology is a plus.
· Proficient knowledge of general toxicology and related disciplines, with evidence of drug development experience.
· Experience with in vitro assays utilized in discovery and toxicological assessment.
· Familiar with regulatory toxicology guidelines, requirements and standards (GLP, OECD, ICH, CTD, etc.) and able develop nonclinical strategies that support clinical development.
· Experience in authoring nonclinical components of regulatory dossiers is a plus.
· Excellent verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management.
Employment Eligibility Chengdu Anticancer Bioscience (ACB) Ltd is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ACB also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of China.