Senior Project Manager, Clinical Biomarker

BeOne Medicines; San Carlos (CA); On-site; USD 140,100 - 185,100; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid Time Off

Wellness programs

Job summary

BeOne Medicines in San Carlos, California, is seeking a highly motivated Operations Manager for biomarker initiatives in clinical trials. The candidate will manage testing activities, collaborate with internal teams, and oversee junior project managers to ensure effective execution of projects.

The ideal applicant will have a strong background in oncology, project management experience of at least 7 years, and excellent communication skills. A competitive salary range of $140,100 to $185,100 is offered along with a comprehensive benefits package.

Qualifications

• 7+ years’ experience with Bachelor or 5+ years with MS, or 3+ years with MD, PhD.
• Experience in the pharmaceutical industry and/or academia is preferred.
• Understanding of scientific concepts and experience in oncology biomarker development.
• At least 7 years project management experience.
• Proven organizational and project management skills.

Responsibilities

• Manage biomarker and bio-sample testing activities for clinical trials.
• Collaborate with internal teams and manage lab vendors.
• Provide updates on biomarker activities in meetings.
• Oversee junior project managers’ work.

Skills

Project management

Communication skills

Analytical thinking

Collaboration

Knowledge of CDx regulations

Education

Bachelor's degree in biology/medical major

MS, MD, or PhD in relevant field

Tools

MS Office

Job description

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 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, and 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, and 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.
• 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

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

Global Competencies

• 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: $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. 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. 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].