About Us:
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 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:
This position will be responsible for the internal and external activities associated with characterizing the preclinical ADME/PK aspects of specific programs in preclinical development, including selection and supervision of CRO, providing PK, in vitro/in vivo drug metabolism and PK/PD modeling and analysis support, study planning and execution, interpretation of pharmacokinetic and ADME data, contributor to relevant sections of regulatory documents including IND or IMPD submissions, briefing packages or background documents and NDA or MAA submissions, supporting clinical pharmacology trial design based on DDI risk analysis based on nonclinical data.
Job Responsibilities:
- Serve as the DMPK representative to ensure effective application and integration of ADME studies in support of discovery and development projects.
- Develop and implement DMPK strategies for specific projects.
- Oversee the design, execution, and interpretation of in vitro and in vivo DMPK studies.
- Ensure high-quality data generation and analysis to inform decision-making in drug discovery and development
- Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- Collaborate with cross-functional teams to integrate DMPK data into overall project plans.
- Provide PK modeling in support of dose selection in biology efficacy studies.
- Support toxicology studies by providing TK analysis for projects.
- Support PK, PD and PK/PD data analyses (including popPK, PK/PD modeling and simulation) for each study/program.
- Perform DDI risk assessment to support clinical pharmacology.
- Contribute to regulatory submissions and interactions with health authorities.
- Maintain up-to-date knowledge of regulatory requirements and scientific advancements in DMPK.
- Provide DMPK input for lead identification, candidate selection, and clinical dose optimization.
- Manage external collaborations and CROs to support DMPK activities.
Qualifications:
- PhD degree in a science discipline with experience or training in drug metabolism, analytical chemistry, life science and/or organic chemistry in small molecule drug discoveries and preclinical development.
- 10+ years industrial experience in drug discovery and development project matrix team.
- Extensive knowledge and experience in DMPK
- Knowledge in non-rule of five oral small molecules DMPK requirements
- Fully understand the regulatory requirements from different health authorities
- Hands-on experience in regulatory filings
- Experience in CRO management
- Strategic thinking and problem-solving abilities.
- Demonstrated strong leadership, interpersonal, collaboration and communication skills and an enterprise mindset.
- Written and verbal fluency in Chinese and English
Skills Required
- PhD in a science discipline with experience or training in drug metabolism, analytical chemistry, life science, and/or organic chemistry related to small-molecule drug discovery and preclinical development.
- 10+ years of industrial experience in drug discovery and development project matrix teams.
- Extensive knowledge and experience in DMPK.
- Knowledge of DMPK requirements for non-rule-of-five oral small molecules.
- Thorough understanding of regulatory requirements from different health authorities.
- Hands-on experience with regulatory filings.
- Experience managing CROs.
- Strategic thinking and problem-solving abilities.
- Strong leadership, interpersonal, collaboration, and communication skills, with an enterprise mindset.
- Written and verbal fluency in Chinese and English.
What We Do
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, Structure Therapeutics has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world.
