Clinical Research Senior Manager

ide 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 China, 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 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, 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 5 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Demonstrate in-depth knowledge in the specific therapeutic areas of oncology, general medicine, inflammation or rare disease

• 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 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

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