Director, DMPK
Structure Therapeutics
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
The 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.
KEY 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 to 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 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.
- Performing PK modeling in support of dose selection in biology efficacy studies.
- Supporting toxicology studies by providing TK analysis for multiple projects.
- Support PK, PD and PK/PD data analyses (including population PK, 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