Biomarker Operations Manager, Lung Cancer Initiative

At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), which is a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and treating lung cancer.

The Johnson & Johnson Lung Cancer Initiative (LCI) is recruiting for a Biomarker Operations Manager to successfully work with all key stakeholders to ensure the biomarker operations and logistics functions are an integral part of the lung cancer initiative. The successful candidate will be accountable for implementation and execution of clinical biomarker sample collection, testing and data delivery activities. This position may be located in Boston MA, New Brunswick NJ, or Spring House PA. Remote locations within North America may be considered on a case-by-case basis and if approved by the company.

Responsibilities:

• Implements biomarker plans into clinical programs for the LCI clinical portfolio
• Creates and maintain plans for the execution of the biomarker strategy including timelines, budget, vendor selection, data transfers and reporting, biobanking and study closeout
• Contributes to central lab SOW development, central lab interactions for biomarkers and any updates or modification of plans-including issue resolution
• 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
• Manage and maintains relationships with external biomarker and business partners to ensure high quality data is generated and reported in line with clinical trials needs
• Partner with procurement and internal business partners to execute, maintain and update biomarker contracts
• Collaborate with data management and data sciences to establish data collection and transfer processes for biomarker vendor labs
• Develop and maintain optimized sample collection, processing, and storage procedures for different sample types and biomarker readouts, with consistency across programs
• Attends study team meeting to provide updates on biomarker implementation, sample collection and data production and reporting
• Leadership skills and demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, internal and external teams to support clinical development strategy

Qualifications

Qualifications:

• A Bachelor degree in a scientific / life sciences discipline is required, a MS is preferred.
• 6 or more years of experience in clinical development and/or biomarker operations is required for a Bachelor degree; 4 or more years of experience is required with a MS degree.
• Knowledge of oncology drug development and/or biomarker development is required.
• Experience working with biomarker vendors to deliver biomarker readouts is required.
• Knowledge and understanding of clinical drug development and strategic planning of clinical research is required.
• Project management experience is preferred.
• Experience working with central laboratories is preferred.
• Experience working with data management to deliver biomarker data is preferred.
• Excellent written and verbal communication skills is required.
• Ability to work on global cross-functional teams effectively and collaboratively is required.
• Strong attention to details, timelines, and quality is required.

The anticipated base pay range for this position is $111,000 to $192,050. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we are on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.