Amgen Director, Clinical Pharmacology Modeling & Sciences in Shanghai, China
Director – Clinical Pharmacology Modeling & Simulation
This China-based position is a member of Amgen’s R&D Team in Asia Pacific region (APAC). The individual will liaise between the regional R&D team and Translational Medicine department to provide strategic vision and portfolio leadership in clinical pharmacology to support execution of early clinical development activities, clinical pharmacology strategy throughout the course of compound development, product registration and post-marketing development of products in this region. The individual is expected to identify and maintain effective relationships with key external collaborators (KOL, SME, CRO) in clinical pharmacology and to ensure effective interactions with the corresponding reputable research institutes and regulatory agencies in the region. The individual must maintain and advance personal and organizational knowledge and expertise in the clinical pharmacology core competency discipline; remain abreast of current and emerging relevant science, technology and regulatory requirements; contribute to definition and implementation of mid and long term scientific/technical strategies to meet current and future business and regulatory demands. The individual is also expected to leverage internal scientific knowledge and experience to influence future regulatory guidance in this region.
This role will also include project management responsibilities in R&D China.
Doctorate degree and 7 years of Clinical Pharmacology experience in the Biotechnology/Pharmaceutical Industry
Knowledgeable to global regulatory requirements, particularly in China and US, for clinical pharmacology studies
Experience interacting with regulatory agencies, particularly with CDE
Experience in leading cross-functional team on early drug development program, designing clinical pharmacology studies and study conduct administration
Experience in clinical study management and operations for phase 1 clinical study in China
Experience in authoring regulatory documents (e.g. IND, CTA, NDA/BLA)
Doctorate degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or (MD or PharmD)
Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
Solid R&D work experience in China and western countries
Solid understanding of GCP and Healthcare Compliance
Ability to work effectively on cross-functional teams
Experienced in interacting with IRBs/Ethics Committees and clinical trial execution teams
Strong leadership quality for effective team building with strong decision making and problem-solving skills
Strong interpersonal skills and organization development skills
Strong oral and written communication skills in Chinese and English
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.