Senior Project Manager, Clinical Biomarker

BeiGene, Ltd.; San Carlos (CA); On-site; USD 140,100 - 185,100; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Equity awards

Employee Stock Purchase Plan

Job summary

BeOne Medicines Ltd. seeks an experienced Biomarker Operations Lead to manage biomarker and bio-sample testing activities for clinical trials. You will oversee lab vendors, collaborate with biomarker scientists and clinical operations, and lead the US biomarker operation team.

The role requires 7+ years in bioscience project management, strong English communication, and a background in oncology biomarker development. Travel is occasional.

Qualifications

• Excellent English verbal and written communication skills.
• Proven organizational and project management abilities.
• Experience in biomarker development or translational research preferred.
• Strong cross-functional collaboration across clinical operations and scientists.
• Ability to manage multiple oncology programs in a fast-paced environment.

Responsibilities

• Independently manage biomarker and bio-sample testing activities for trials.
• Oversee lab vendor performance and liaise to resolve issues.
• Collaborate with biomarker scientists and clinical operations to drive biomarker work.
• Lead cross-functional biomarker operation activities and initiatives.
• Review study documents and train sites on sample handling and timelines.
• Participate in study and program meetings with biomarker updates.
• Ensure CDx strategy alignment with device partners and labs.
• Oversee junior project managers and biomarker operation team in the US.

Skills

English communication

Project management

Cross-functional collaboration

Biology/pharma knowledge

Education

Bachelor degree in biology/medical major

MS in biology/medical major

MD/PhD in biology/medical major

Tools

MS Office

Job description

Overview

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. 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.

Responsibilities

• Independently manage biomarker and bio‑sample testing activities for clinical trials, including review and finalization of lab vendors key documents (lab manual, database design documents, contracts & budget, etc.), track bio‑specimens, schedule and execute bio‑specimen testing based on study needs.
• Oversee lab vendor performance and serve as key vendor liaison to resolve account‑level issues and improve collaboration and processes.
• Collaborate and communicate with internal functional stakeholders (biomarker scientists, clinical operations and others) to drive biomarker related work, manage lab vendor timelines, control biomarker budget, ensure compliance and quality, etc.
• Build collaborative relationships with cross‑functional teams as biomarker operation representative and lead/participate in cross‑functional activities and initiatives.
• Collaborate internally to review key study documents such as ICF, EDC design specification, IRC integration specification, and provide training to investigator sites 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.
• Maintain knowledge of CDx regulations and manage three‑way communications with device partners and lab vendors to ensure biomarker and CDx strategy implementation.
• Participate in vendor selection activities at program/platform level and provide operational insights.
• Oversee junior project managers’ work and performance; lead US biomarker operation team.

Supervisory Responsibilities

• Provide training and coaching to project coordinators and junior project managers.
• Manage performance of project coordinators and junior project managers.

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 pharmaceutical industry and/or academia 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 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.
• High sense of responsibility and ability to respond quickly.

Travel

• Occasionally Global.

Salary Range

$140,100.00 - $185,100.00 annually.

Benefits

BeOne is committed to fair and equitable compensation practices. Packages may vary by location due to differences in cost of labor. 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.

EEO Statement

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.

Reasonable Accommodation

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].