Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary

In charge of non-clinical development activities from safety perspective for candidate selection, IND-enabling program for regulatory submission, and continued development in the entire lifecycle of the product pipeline; facilitate and execute non-clinical studies for target evaluation and other assessment on needed basis. Literature retrieval on competitor landscape and novel technologies in the field.

KEY RESPONSIBILITIES

• Design and manage non-clinical toxicology studies (GLP and non-GLP) for inclusion in regulatory submissions following latest regulatory requirements.

• Oversee non-clinical CROs in study design, execution, trouble shooting, report writing, and interpretation of toxicology studies, and conduct on-site inspections to ensure that studies are delivered with speed and quality under mutually agreed price.

• Review non-clinical study reports to ensure accurate reflection of study data. Conduct integrated interpretation of the study results to support clinical development strategy.

• Prepare and edit non-clinical documents for regulatory submission and regular updates for life-cycle management.

• Work with other functions to support target evaluation, candidate selection, CMC process changes, clinical protocol development, annual report and RA submissions.

QUALIFICATIONS:

• D. scientist with 5+ years of industry experience. Background in toxicology, pharmacology, pathology, or related fields. Globally certified toxicologist preferred.

• Familiar with regulatory guidelines from different regional countries on IND/NDA toxicity studies.

• Prior experience in early drug screening and candidate selection.

• Prior experience in toxicology evaluation for non-oncology small molecules, metabolic, CNS, renal and liver disease area preferred.

• Proven capability of working in a fast-paced dynamic environment. Strong execution preferred.

• Literature and database retrieval ability.

• Good written and verbal communication skills in both Chinese and English.