An exciting opportunity at Haihe Biopharma, a global clinical stage biopharma focusing on the discovery and development of innovative targeted Oncology therapies. The company has multiple assets in clinical development and a rapidly growing pipeline of innovative early stage assets entering clinical trials globally, including multiple Phase I, Phase II clinical trials in the US.
*Job summary:* The role will provide Clinical Pharmacology and Pharmacometrics contributions for the assigned projects. You will lead or work collaboratively with other scientists in Clinical Pharmacology and cross functionally with other groups within Haihe. Activities will include: develop clinical pharmacology strategy, author PK/PD related sections of clinical trial protocols, draft PK/PD report in CSR for clinical studies, 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. The position is Manager to Associate Director level depending on the experience. To apply for the position, please send your resume to yuhong.c...@haihepharma.com *Key Responsibilities:* · Serve as the Clinical Pharmacology expert on early and/or late-stage and/or life-cycle project teams · 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 · Draft PK/PD report in CSR for clinical studies, including clinical pharmacology studies and phase I to III clinical trials · Collaborate and/or perform modeling and simulation analysis of pre-clinical and clinical PK/PD data to guide FIH dose prediction and/or inform Phase 2&3 dose selection · Interact with world health authorities including EOP1, EOP2 and marketing application related meetings · Collaborative review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses · Coordinate and coauthor external presentations and publications *Qualifications* *Education Required:* - MS or 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, regulatory and postdoctoral experience in the field of Clinical Pharmacology and Pharmacometrics - Experience in the early and late stage development of small molecules and/or biologics is essential - Good hands-on skills in PK/PD modeling tools (e.g., NONMEM, Phoenix WinNonlin/NLME and R) *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.*
