Description

Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager role could be an exciting opportunity to explore.

As a Clinical Development Manager, you will participate in Phase I-IV Clinical Development and Epidemiology activities within a program or group of related programs to ensure the high quality and on-time delivery of scientific data.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Participate in Clinical Development and Epidemiology activities for a study or studies within a specific program or group of related programs.

• Design clinical trial and epidemiology study protocols, and author study reports and publications of high scientific, operational and ethical standards under the supervision of an experienced senior Clinical Research Development Lead (CRDL), senior Epidemiologist or Clinical Epidemiology Program Lead (CEPL).

• Responsible for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including Investigator's Brochure and the Study Report.

• Supervise the study conduct and serve as the accountable for the overall delivery of clinical and epidemiology trials and as a scientific and management reference for the project (internally/externally).

• Support the Senior CRDL, Senior Epidemiologist or CEPL in representing therapy area in meetings with health authorities and the scientific community where applicable.

• Assemble and transmit timely summaries of clinical safety data for review by the competent medical officer and publish clinical and epidemiology data in peer review journals and presents in external scientific meetings/congresses.

• Responsible for Data Listing review for the medical portion of data listing for individual studies and assuring medical consistency within a trial and across trials within program.

• Address scientific and medical issues related to one or more clinical/epidemiology studies paying special attention to serious adverse events and potential safety signals and ensures study results meet the highest standards of quality and ethical conduct.

• Liaise with the Regional Evidence Generation and the Local Medical Leads to ensure alignment of clinical/ epidemiology trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).

• Actively participate in preparing the clinical portion of the regulatory files and the registration process and contributes to development of clinical section of regulatory files, including labelling.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master's degree
• Direct experience with Good Clinical Practices (GCP), Good Epidemiology Practice (GEP), regulatory guidelines
• Experience overseeing the medical and human safety aspects of clinical programs

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD or Doctor of Medicine (MD)
• Experience independently conducting clinical research, critically evaluating scientific aspects of immunology
• Ability to work in matrix environment and multi-task through good planning and organization skills
• Effective ability to prioritize tasks and deliver on deadlines
• Ability to translate scientific skills in clinical research into business-driven strategies

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

我们的目标是成为全球最具创新精神、业绩最佳、最值得信赖的医疗保健公司之一。我们相信,我们所有人都为 GSK 带来了一些独特的东西,当我们把我们的知识、经验和风格结合在一起时,将会实现令人难以置信的影响力。欢迎加入 GSK,您将受到启发,为我们的患者和消费者提供最好的服务。在这里,您可以做你自己,在愉悦的工作环境中不断发展进步。

面向职业介绍所/就业机构的重要通知

GSK 不接受职业介绍所和/或就业机构就本网站上发布的职位空缺所做的引荐。所有职业介绍所/就业机构均须联系 GSK 的商业及一般采购/人力资源部门,以取得事先书面授权,才可将任何应聘者推荐给 GSK。取得事先书面授权是职业介绍所/就业机构与 GSK 之间达成任何协议(口头或书面)的先决条件。在没有获得书面授权的情况下,职业介绍所/就业机构所采取的任何行动均应被视为未经 GSK 同意或在未达成合同协议的情况下进行。因此,GSK 无须就此类行动或职业介绍所/就业机构就本网站所发布的职位空缺进行的引荐所产生的任何费用负责。