Independently lead the clinical pharmacology strategy for our Clinical Development projects and play akey role in Project and Study teams.
In this highly visible role, you will present clinical pharmacology plans, updates, and results to project teams and senior management.
Lead the Clinical Pharmacology aspect of clinical development in collaboration with toxicology and DMPK
Lead the DDI risk evaluation and contribute to the design of clinical DDI evaluation strategy in collaboration with DMPK
Serve as Clinical Pharmacology subject matter expert and contribute to the safety/efficacy evaluations of our clinical stage projects
Work closely with Regulatory, Medical Writing, CMC and Clinical Development groups for IND and NDA filings and other regulatory interactions in support of clinical programs
Effectively interact and manage collaborations with CROs/CMOs and external consultants for outsourcing activities and conduct clinical pharmacology studies in NHV.
Ph.D. in, pharmaceutical sciences, pharmacology, or related field, or Pharm.D. with clinical pharmacology and pharmacokinetic training and experience (at least 6-8years working experience in Oncology products phase1-3 clinical trials, oversea projects experience with excellent oral English capability preferred). M.S. degrees with applicable experience will also be considered
Experience managing CROs offering Clinical Pharmacology services
Experience in preparation of clinical study protocols and regulatory documents, incl. IND, CTA, IB, NDA, etc.
Extensive background knowledge in Clinical Pharmacology. Proficiency in discussing clinical pharmacology, pharmacokinetics, toxicology, and bioanalytical concepts and results to audiences of varied backgrounds is required
Working knowledge of Clinical Pharmacology-related regulations and regulatory guidelines from ICH, FDA and EMA.
Track record of successful collaboration in project team setting, and achievement of milestones in a time efficient manner.
Strong communication and presentation skills, and attention to detail.
If you are interested in this position, please send your resume to us!
Beijing：renshanghe@sumgenbio.com +86-10-56315401-808 Ms. Ren
Hangzhou/Shanghai：hr@sumgenbio.com +86-571-86837379 Ms. Zhao
Copyright Rm. 301, F3, Building C, Block 2, No. 688, Bin'an Road, Changhe Zhejiang ICP Filing No. 18039044
