Clinical Research Senior Manager

Amgen Inc.

3.6

(9)

Shanghai, China

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-217292

    Position summary

    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

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging