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General Description:

Manage biomarker related operational work for clinical trials and programs. Act as biomarker operation representative to lead/participate in cross-functional activities and initiatives. Act as key vendor liaison to manage vendor relationship, resolve account level issues and improve processes. Oversee and manage the performance of junior project managers.

Essential Functions of the job:

+ Independently manage biomarker and bio-sample testing activities for clinical trials, including but not limited to review and finalize lab vendors key documents (such as lab manual, lab database design documents, contracts & budget, etc. ) , track bio-specimens, schedule and execute bio-specimen testing based on study needs. Oversee lab vendor performance and act as key vendor liaison to resolve account level issues and improve collaboration and processes.

+ Collaborate and communicate with internal functional stakeholders including biomarker scientists, clinical operations and others, to drive the biomarker related works for clinical trials, such as manage lab vendors timeline, control biomarker budget, ensure compliance and quality, etc. Build collaborative relationships with cross-functional teams as biomarker operation representative and lead/participate cross-functional activities and initiatives.

+ Collaborate with internal teams to review key study documents such as ICF, EDC design specification, IRC integration specification, etc. and provide training to investigator sites as needed for sample collection schedule, sample processing and shipment, etc.

+ Participate in clinical study team meetings and program meetings, providing updates and insights related to biomarker activities and progress.

+ Have a good knowledge of CDx regulations and manage three-way communications with both device partners and lab vendors to make sure biomarker strategy and CDx strategy is implemented. Participate in vendor selection activities at program/platform level and provide insights from operational perspective.

+ Oversee junior project managers’ work and performance. Lead US biomarker operation team.

Supervisory Responsibilities:

+ Provide training and coaching to project coordinators, junior project managers

+ Manage project coordinators/junior project managers performance

**Computer Skills:** Proficient in MS office

Other Qualifications:

+ 7+ years’ experience with Bachelor or 5+ years with MS, or 3+ years with MD, PHD in biology/medical major.

+ Experience in the pharmaceutical industry and/or academia is preferred

+ Understanding of scientific concepts and experience in translational research and oncology biomarker development.

+ At least 7 years project management experience

+ Proven organizational and project management skills and the ability to manage cross-functional efforts.

+ Ability to work effectively on multiple oncology programs in a fast-paced, dynamic environment

+ Excellent verbal and written English communication skills

+ Have a high sense of responsibility and can respond quickly

**Travel:** Occasionally

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.