诺华中国 · Development

TA Lead (REQ-10060086)

薪资面议  /  上海

今天 17:10 更新

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职位属性

  • 招聘类型:社招
  • 工作性质:全职

职位描述

-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

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.

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任职条件

Clinical Research

Risk Management

Leadership

Strategy Development

Clinical Decision Making

Disease Area Knowledge

People Management

Drug Development

Clinical Trials