Senior Project Manager, Clinical Biomarker

Role 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.

• 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
• Build collaborative relationships with cross-functional teams as biomarker operation representative and lead/participate in 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
• 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 ensure 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.

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.

Requirements

• Proficient in MS Office.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Salary Range

$140,100.00 - $185,100.00 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.