Description
**Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6**
We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – 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 Amgen Pipelines in oncology and general medicine
+ To contribute to define, design, and execute clinical development as a strategy for drug development in Korea.
+ To serve as key role in external collaboration and strategic partnership with key local sites in clinical studies and related research area
+ 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.
**Responsibilities:**
+ Lead and/or contribute to designing, gaining approval of and executing high quality development strategy for assets in Korea, collaborating with cross-function local colleagues and global partners, together with key functional stakeholders and governance bodies
+ Support the development and execution for clinical trials in Korea 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, 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
+ 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 therapeutic areas of oncology, hematology and/or general medicine
+ 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
