Career Category

Job Description

Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6

We are building upon our solid foundation in discovering and developing innovative new medicines and long-term commitment to patients by developing by expanding our portfolio in Oncology, Cardiovascular/Metabolism and Inflammatory diseases 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 across the Amgen Pipeline in both oncology and general medicine
• 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 for clinical trials in the 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 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 the Global Development Lead to :
• Contribute or lead 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, provide medical and strategic oversight to the study execution. 
• Monitor, analyse, 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 presentation 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 providing 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 successfully submission and approval of CTNs and MAAs
• Establish and maintain appropriate relationship 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 7- 8 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Demonstrate in-depth knowledge in 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