Job Information
Amgen Clinical Research Senior Manager in Seoul, South Korea
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 78 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