Clinical Program Mgr

Arbeitsbeschreibung

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Knowledge:
Excellent interpersonal skills, and demonstrated ability to lead is required.
Experience in managing staff as well as mentoring and developing junior staff is required.
Strong communication and influence skills and ability to create a clear sense of direction is necessary.
Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
Experience in developing RFPs and selection and management of CROs/vendors.
Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
Ability to examine functional issues from a broader organizational perspective.
Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
Specific Education & Experience Requirements:
8+ years of experience and a BS or BA in a relevant scientific discipline.
8+ years of experience and an RN (2 or 3 year certificate).

职位要求（Knowledge & Skills）
-具备优秀的人际沟通能力，并具备团队领导能力
-具有团队管理经验，能够指导、培养并发展初级成员
-具备出色的沟通和影响力，能够清晰传达方向并推动执行能够基于国内外法规、行业指南及与研究者的沟通，独立解决临床试验中的问题
-具有丰富经验，能够成功设计、执行、管理并完成临床试验项目
-深入了解以下临床合规要求：

FDA / EMEA 相关法规
ICH 指南
GCP（临床试验质量管理规范）

-具备RFP制定经验，并能完成CRO/供应商的筛选、管理与评估，能够在较少监督下完成以下文件撰写：临床试验方案（Protocol），临床研究报告（CSR）
,Investigator’s Brochure相关内容, 注册申报材料（如 IND、NDA等）

-具备从更高组织层面审视和解决问题的能力（全局视角）能够在较少指导下，参与或主导部门或跨部门战略项目

-具备专业能力，能够参与或主导：SOP的制定、实施及培训

教育背景与经验要求（Education & Experience）

-具有至少 8年以上相关工作经验, 相关生命科学/医学等专业，本科及以上学历
-具有至少 8年以上相关工作经验或持有（RN）资质（2-3年认证项目）

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Job Title (Translated)

临床项目经理

Job Description (Translated)

职位要求（Knowledge & Skills） -具备优秀的人际沟通能力，并具备团队领导能力 -具有团队管理经验，能够指导、培养并发展初级成员 -具备出色的沟通和影响力，能够清晰传达方向并推动执行能够基于国内外法规、行业指南及与研究者的沟通，独立解决临床试验中的问题 -具有丰富经验，能够成功设计、执行、管理并完成临床试验项目 -深入了解以下临床合规要求： FDA / EMEA 相关法规 ICH 指南 GCP（临床试验质量管理规范） -具备RFP制定经验，并能完成CRO/供应商的筛选、管理与评估，能够在较少监督下完成以下文件撰写：临床试验方案（Protocol），临床研究报告（CSR） ,Investigator’s Brochure相关内容, 注册申报材料（如 IND、NDA等） -具备从更高组织层面审视和解决问题的能力（全局视角）能够在较少指导下，参与或主导部门或跨部门战略项目 -具备专业能力，能够参与或主导：SOP的制定、实施及培训 教育背景与经验要求（Education & Experience） -具有至少 8年以上相关工作经验, 相关生命科学/医学等专业，本科及以上学历 -具有至少 8年以上相关工作经验或持有（RN）资质（2-3年认证项目）