BeiGene
Sr. Project Manager, Clinical Biomarker
BeiGene, San Carlos, California, United States, 94070
Biomarker Manager
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description
Manage biomarker related operational part for clinical trials and 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, track bio-specimens, schedule and execute bio-specimen testing based on study needs, oversee lab vendor performance and provide biomarker related expertise for clinical trials conduction from an operational perspective. 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. Collaborate with internal 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, 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 Oversee junior project managers' work and performance. 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
Bachelor or above in biology/medical major. At least 7 years project management experience Experience in the pharmaceutical industry and/or academia is preferred Understanding of scientific concepts and experience in translational research and oncology biomarker development. 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 When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $135,400.00 - $180,400.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description
Manage biomarker related operational part for clinical trials and 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, track bio-specimens, schedule and execute bio-specimen testing based on study needs, oversee lab vendor performance and provide biomarker related expertise for clinical trials conduction from an operational perspective. 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. Collaborate with internal 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, 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 Oversee junior project managers' work and performance. 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
Bachelor or above in biology/medical major. At least 7 years project management experience Experience in the pharmaceutical industry and/or academia is preferred Understanding of scientific concepts and experience in translational research and oncology biomarker development. 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 When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $135,400.00 - $180,400.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.