REQ-10060086
9月 16, 2025
China

摘要

-Designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establishes the criterion essential for determining the safety, efficacy, and medical utilities. Interprets results of Phase I-III investigations in preparation for new-drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post marketing studies

About the Role

Major accountabilities:

  • Is a global clinical leader responsible for clinical program(s) across indications or a large regional clinical leader driving medical strategy for development and marketed products in a defined therapeutic area -Owns the risk benefit assesment for the program(s) -Is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access -Leads execution on broad strategic direction and contributes to development of disease/therapeutic area strategy -Leads the creation of clinical components of key documents e.g., Clinical Trial Protocols (CTPs), Investigator’s Brouchures, Clinical Study Reports (CSRs), regulatory documents etc. with high levels of quality and consistency -Acts as the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders -Collaborates across functions to ensures continuous evaluation of drug safety profile -Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program -Ensures career development of program reports through active participation in the performance management -Distribution of marketing samples (where applicable)

Key performance indicators:

  • Achievement of unit objectives -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations.

Minimum Requirements:
Work Experience:

  • Strategy Development.
  • Functional Breadth.
  • People Challenges.
  • People Leadership.
  • Representing the organization.

Skills:

  • Clinical Decision Making.
  • Clinical Research.
  • Clinical Trials.
  • Disease Area Knowledge.
  • Drug Development.
  • Leadership.
  • People Management.
  • Risk Management.
  • Strategy Development.

Languages :

  • English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

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REQ-10060086

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