Elpiscience is a clinical stage biopharmaceutical company focusing on cancer immunotherapy. The company is committed to leading the innovation and development of the next generation of cancer immunotherapies for the benefit of cancer patients worldwide. Elpiscience has a pipeline of more than 10 innovative molecules in discovery, covering a wide range of targets with a particular focus on innate immunity and tumor microenvironment. Its most advanced assets, ES002, ES102 and ES104 are in Phase I clinical stage, and three in-house developed candidates with first-in-class potential are currently being evaluated in IND-enabling studies.
*Job summary:* The role will provide Clinical Pharmacology contributions for the assigned projects. You will lead or work collaboratively with other scientists in Clinical Pharmacology and cross functionally with other groups within Elpiscience. Activities will include: lead FIH dose prediction, author PK/PD related sections of clinical trial protocols, provide clinical pharmacology support during SMC review and participate in project team discussions. You will also lead submission efforts on the clinical pharmacology section and interact with world health authorities regarding submissions and subsequent queries. To apply for the position, please send your resume to yuhongc...@elpiscience.com *Key Responsibilities:* · Manage and deliver relevant sections of clinical pharmacology strategy, protocols, and clinical study reports by working with other scientists in a matrix environment · Analyze PK/PD data of FIH study and present in SMC meeting, provide clinical pharmacology support on dose escalation strategy, MTD determination and RP2D selection · Oversee or perform modeling and simulation analysis of pre-clinical data to guide FIH dose prediction · Oversee or perform modeling and simulation analysis clinical PK/PD data to guide RP2D selection · Interact with world health authorities including EOP1, EOP2 and marketing application related meetings · Coordinate and coauthor external presentations and publications *Qualifications* *Education Required:* - Ph.D. in Pharmaceutical Science, Clinical Pharmacology, Pharmacokinetics, Biomedical Engineering or a related field in the biological sciences *Experience and Skills* *Required:* - At least 3 to 5 years in combined industry and regulatory experience in the field of Clinical Pharmacology - Experience in the early and late stage development of biologics is essential - Good hands-on skills in PK/PD modeling tools (e.g., NONMEM, Phoenix WinNonlin/NLME and R) is plus *Other:* - Team player works with others respectfully and cordially - The ability to adapt, work through conflicts, and persuasively influence outcomes. - Effectively cope with change and is comfortable changing direction and acting without complete information - Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectives - Ability to develop and deliver effective presentations and written/oral communications. - Thrives in a fast-paced business environment - Willingness to work flexible schedule/hours *Location:* · US/China · Home-based (US) or Shanghai China *We provide competitive compensation package, including 401K, health insurance and paid vacation days.*
