Company Overview

Cullgen is a privately held biopharmaceutical company dedicated to the development of first-in-class new chemical entities (NCEs) for the treatment of diseases lacking effective therapeutic approaches through targeted protein degradation technology (TPD, also known as PROTAC). Cullgen is making major efforts in advancing the technology, concentrating on the discovery of novel E3 ligands. The Company’s technology platform, uSMITE™, is designed to treat cancer and immune diseases through ubiquitin-mediated, small molecule-induced target elimination of disease-causing proteins that are previously considered as undruggable.

Embracing the globalization of healthcare R&D, Cullgen has initiated drug discovery and business development efforts in the United States, Japan and China to build a strong, collaborative and efficient international drug discovery platform.

Position Summary

Cullgen is seeking a highly motivated and innovative scientist to serve as a scientific and team leader for our DMPK program. The successful Director/Senior Director, DMPK, will have a proven track record of accomplishment in both science and project management. Principle duties of this position will require scientific, technical, and managerial skills. Experience working in both industry and academia is preferred. This position can be located in either San Diego, CA or Shanghai, China.

Key Responsibilities:

• Represent DMPK discipline, from assessment of new targets, identifying and refining key DMPK aspects of the TPP, supporting SAR, driving selection and nomination of clinical candidates, while collaborating closely with Medicinal Chemistry and Translational Medicine teams.

• Lead in-house strategies for metabolic profiling/structure elucidation, DDI, plasma protein binding, understanding metabolic liabilities to support discovery and development projects.

• Manage a group of RAs and use technical knowledge in high-resolution LC- MS/MS and ADME assays to support their experimental ADME efforts.

• Design, implement and oversee in vitro assays using sub-cellular and cell-based systems (microsomes, hepatocytes, cell lines, transporters) and in vivo PK/PD experiments to enable project team decision.

• Identify, select and qualify Contract Research Organizations (CROs).

• Design and coordinate DMPK studies at CROs, and manage the conduct of DMPK studies carried out by CROs, including review of protocols, reports and data presentations.

• Prepare high-quality preclinical DMPK reports to support candidate nominations and co-author high-quality regulatory documents including INDs, CTAs, and NDAs.

• Represent clinical pharmacology function to clinical development team.

• Compile and present data to internal and external audiences.

• Attend meetings with the FDA, NMPA, EMA, etc. as necessary to support submissions and regulator question responses

Qualifications:

• PhD. with 10+ years of relevant industry experience in the field of ADME and clinical pharmacology, ideally with experiences to bring small molecular compound from pre-clinical to clinical and to NDA.

• Strong understanding of drug metabolism and ADME principles including enzyme kinetics, IVIVC, and DDI risk assessment.

• Broad understanding of DMPK concepts and relevant areas such as physicochemical properties, drug-metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences required.

• Demonstrated leadership capability to mentor junior scientists in a matrix environment, build strong relationships cross-functionally and with academic and CRO partners, to drive productivity of the team to meet company deliverable objectives.

• Essential knowledge of regulations in FDA and NMPA, EMA.

• Good oral and written communication skills in both English and Chinese