Hybrid Biomarker & Diagnostic Operations Leader – Oncology

at Johnson & Johnson

• Job title: Biomarker & Diagnostic Operations Leader – Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $105,000 - $169,050 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Spring House, United States

About the role

• Biomarker & Diagnostic Operations Leader overseeing oncology clinical sample collection and testing strategy. Collaborating with teams to ensure timely execution of clinical programs for oncology.

Responsibilities

• Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology
• Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout
• Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables
• Contributes to central lab setup and management throughout the course of a study
• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications
• Works closely with data management to establish data collection and transfer processes with testing vendors and local labs
• Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials
• Develops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetings
• Manages relationships with internal and external partners to ensure on-time and quality deliverables

Requirements

• A bachelor’s degree in a scientific/ life science discipline is required.
• 5+ years of work experience in clinical development, and/or biomarker or diagnostics development and/or Pharmaceutical/biotech R&D
• Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required
• Project management experience is preferred
• Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred
• Excellent written and verbal communication skills
• Ability to effectively and collaboratively work on global cross-functional teams

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year