• 招聘类型：社招
• 工作性质：全职
• 所属区域：Clinical Development / Science

职位描述

1. Cross-Functional Team Membership & People Management

• Participates in the relevant Therapeutic Team (TT)
• Represents CD in Study Team relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

2. Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in Clinical Development, research, business development, commercial operations, legal, etc.
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Participates in CD strategy development and may present to various internal committees
• Supports Medical Directors in creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs
• Supports Medical Director in the communication with HAs, as and when needed, or otherwise appropriate. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders

3. Clinical Development Plan Implementation

• Supports Medical Director in the implementation of all relevant studies and programs:

o Participates in ongoing TT and relevant study team meetings, other interactions and communications

o Develops innovative clinical study designs for review and discussion with Medical Directors. Conduct appropriate literature searches

o Collaborate with clinical operations, other groups to develop consistent language and criteria for informed consent form ICF), protocol, case report forms (CRF), CRF instructions, etc.

o Reviews and/or writes additional medical documentation and/or provide medical input as requested or needed, e.g. protocol synopsis, safety monitoring plans, process documents, investigator brochures, or other relevant presentations or materials.

o Conducts ongoing reviews of medical/safety data

o Collaborates with clinical operations to develop and implement the overall data quality plan

Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, BeiGene Standard Operating Procedures (SOPs) and other guidelines

任职条件

1. Qualification

• M.D. with relevant medical experience in Oncology area required. Academic/teaching background is a plus.

2. Experience

• >3 years pharma/biotech industry experience OR is a recognized expert in the field
• >3 years experience with clinical trials, Oncology trials is a plus.

3. Personal Competencies

• Fluent in English
• Good communication skills, both written and verbal

4.Ability to travel globally (<30%)

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要