Clinical Research Senior Manager

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><p>We are building upon our long-term commitment to patients by developing a whole new class of novel molecules in oncology, general medicine, inflammation and rare disease – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.</p><p></p><p><b>Accountabilities</b></p><ul><li>To serve as local development lead for phase I-III clinical development of Amgen Pipelines</li><li>To contribute to define, design, and execute clinical development as a strategy for drug development in China.</li><li>To serve as key role in external collaboration and strategic partnership with key local sites in clinical studies and related research area</li><li>To represent Medical Sciences internally and externally, contributing local medical insight into experimental design and data analysis.</li><li>To provide subject matter expertise in clinical and translational trial science as well as the biology and treatment.</li></ul><p></p><p></p><p><b>Responsibilities:</b></p><ul><li>Lead and/or contribute to designing, gaining approval of and executing high quality development strategy for assets in China, collaborating with cross-function local colleagues and global partners, together with key functional stakeholders and governance bodies</li><li>Support the development and execution for clinical trials in China and be the local/regional medical science expert in resolving significant issues that may affect the studies</li><li>Work closely with <span>local/regional/global</span> cross functional colleagues, including Clinical Operations, Patient Safety and Regulatory counterparts, to provide medical expertise to the study team</li><li>Share local/regional clinical/scientific input during the development and execution of clinical trials</li><li>In defined situations working under the Global Development Lead to :</li><li>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).</li><li>Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution. </li><li>Monitor, analyse, and interpret clinical study data</li><li>Contribute to the preparation of documents required for regulatory submissions</li><li>Develop and interface with local/regional industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings</li><li>Participate in interactions with regulatory agencies</li><li>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</li><li>Ensuring compliance with GCP across clinical trials</li></ul><p></p><p><b>Output</b></p><ul><li>Ensure <span>local/regional/global</span> clinical studies are adequately and timely supported and executed</li><li>Ensure medical support leading to successfully submission and approval of CTNs and MAAs</li><li>Establish and maintain appropriate relationship with local/regional industry key opinion leaders and medical communities</li></ul><p></p><p><b>Skills and Qualities</b></p><ul><li>MD degree from an accredited medical school, and experience in patient care required</li><li>Minimum 5 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)</li><li>Demonstrate in-depth knowledge in the specific therapeutic areas of oncology, general medicine, inflammation or rare disease</li><li>In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale</li><li>Familiarity with concepts of clinical research and clinical trial design, including working knowledge of statistics as applied to clinical trial design and analysis</li><li>Previous experience in early and/or late-stage clinical trials and regulatory filings</li><li>Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication</li><li>Experience in writing and editing scientific research reports</li><li>Thorough understanding of GCP and familiarity with relevant NMPA and ICH guidance</li><li>Ability to collaborate effectively in and/or lead cross-functional teams</li><li>Strong commitment to goals and timelines</li><li>Ability to absorb new information quickly and gain command of relevant literature</li><li>Possessing excellent problem-solving &amp; decision-making skills</li><li>Excellent written and verbal communication skills, including fluency in English</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.