Job Description:
We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.
ACCOUNTABILITIES
- To serve as local development lead for phase I-III clinical development of oncology compounds
- To contribute to define, design, and execute clinical development as a strategy for drug development
- To represent Medical Sciences internally and externally, contributing local medical insight into experimental design and data analysis.
- To provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
RESPONSIBILITIES:
- Lead and/or contribute to designing, gaining approval of, and executing high-quality development strategy for oncology assets in China, collaborating with cross-function colleagues in the C-EGT and the global EGT, key functional stakeholders, and governance bodies
- Support the development and execution of clinical trials in China and be the local/regional medical science expert in resolving significant issues that may affect the studies
- Work closely with local/regional/global cross-functional colleagues, including Clinical Operations, Biometrics, Patient Safety, and Regulatory counterparts, to provide medical expertise to the study team
- Share local/regional clinical/scientific input during the development and execution of clinical trials
- Contribute or lead the development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
- In defined situations working under Global Development leads to :
- Contribute or lead the development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
- Serve as a member of the CST-LT, and provide medical and strategic oversight to the study execution.
- Monitor, analyze, and interpret clinical study data
- Contribute to the preparation of documents required for regulatory submissions
- Develop and interface with local/regional industry key opinion leaders and manage scientific presentations at advisory boards, key scientific meetings, and external committee meetings
- Participate in interactions with regulatory agencies
- Support the local/regional Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help provide interpretation of clinical study data
- Ensuring compliance with GCP across clinical trials
OUTPUT
- Ensure local/regional/global clinical studies are adequately and timely supported and executed
- Ensure medical support leading to successful submission and approval of CTNs and MAAs
- Establish and maintain appropriate relationships with local/regional industry key opinion leaders and medical communities
SKILLS AND QUALITIES
- MD degree from an accredited medical school and experience in patient care required
- Minimum 5 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Demonstrate in-depth knowledge of Oncology and/or Hematology
- In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
- Familiarity with concepts of clinical research and clinical trial design, including working knowledge of statistics as applied to clinical trial design and analysis
- Previous experience in early and/or late-stage oncology clinical trials and regulatory filings
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Experience in writing and editing scientific research reports
- Thorough understanding of GCP and familiarity with relevant NMPA and ICH guidance
- Ability to collaborate effectively in and/or lead cross-functional teams
- Strong commitment to goals and timelines
- Ability to absorb new information quickly and gain command of relevant literature
- Possessing excellent problem-solving & decision-making skills
- Excellent written and verbal communication skills, including fluency in English
Join Us
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 diseases, 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.
