Director to Senior Director, Toxicology

About Us:

Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys 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 clinicalstage 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 completed an initial public offering (IPO) in February 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 from lead screening candidate selection IND-enabling program and continued late-stage development in the entire lifecycle of the product pipeline.
• Draft/review regulatory submission documents to regulatory agencies of various regions.
• Facilitate and execute non-clinical studies for target evaluation and other assessment on needed basis.
• Conduct literature retrieval and in silico analysis on novel technologies in the toxicity field.

Job Responsibilities:

• Design and manage non-clinical toxicology studies (GLP and non-GLP) 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 deliver appropriate safety evaluation of the product in support of clinical development strategy.
• Prepare and edit non-clinical documents for regulatory submission and regular updates for life-cycle management.
• Serve as functional representative to work with cross functions to support target evaluation lead screening candidate selection CMC process changes clinical protocol development annual report and RA submissions.
• Maintain a current understanding of literature and methodology from safety perspective. Get understanding of the latest status of competitors in the market to guide candidate product development.
• On needed basis design customized exploratory study to address specific request by taking advantage of classical and alternative platform or methodology.
• Stakeholder management across global cross-functional teams

Qualifications:

• Ph.D. scientist with 10 years of industry experience. Background in toxicology pharmacology pathology or related fields. Globally certified toxicologist preferred.
• Familiar with regulatory guidelines (ICH OECD regional requirements) and experience in IND/NDA toxicity studies.
• Strong understanding of target organ toxicity and mechanisms
• Prior experience in early drug screening and candidate selection. Working with academic research institute preferred.
• Prior experience in toxicology evaluation for non-oncology small molecules metabolic CNS renal and liver disease area preferred.
• Experience on Combination toxicity evaluation is preferred.
• Prior regulatory agency interactions as a lead representative is preferred.
• Proven capability in integrated analysis and trouble-shooting.
• Proven capability of working in a fast-paced dynamic environment.
• Literature and database retrieval ability.
• Strong responsibility and self-motivation.
• Good written and verbal communication skills in both Chinese and English

Required Experience:

Exec

Employment Type : Full-Time
Experience: years
Vacancy: 1