Associate Director, Biomarker Strategy - Interventional Oncology

Key Skills

Data science techniques, Google Cloud Platform (GCP), Oncology, Operations, RNA-seq Data processing

Job Description

The Associate Director, Biomarker Strategy will have responsibility for developing and effectively implementing biomarker strategies to support the clinical development plans for projects within the Interventional Oncology portfolio. Working as part of the development team, the candidate will develop and validate molecular, immunological, pathological, and/or imaging biomarkers to select patients, monitor pharmacodynamic activity and evaluate response to treatment. Additionally working with the Discovery team to support the clinical translation of the Interventional Oncology preclinical portfolio.

Key Responsibilities:

• Develop and maintain translational and clinical biomarker strategies to support assets within the Interventional Oncology portfolio.

• Contribute biomarker strategy input at development team meetings and governance reviews.

• Support the development of biomarker related aspects of the trial design, study protocols, lab manuals, clinical study reports, investigator brochures and regulatory documents.

• Work with the Biomarker Operations team and biomarker vendors to deliver validated biomarker assays.

• Collaborate with the Discovery team to develop plans for clinical translation of biomarkers.

• Work with the Data Science group to develop and implement data analysis strategies to deliver biomarker plans.

QUALIFICATIONS

• A PhD in life sciences is required

• Five or more years of experience in biomarker development and implementation in oncology clinical trials is required.

• Experience and track-record of the discovery, validation and clinical implementation of biomarker readouts-especially genomic and transcriptomic profiling, histological/pathological readouts, and immunological readouts is required.

• Experience of working with Contract Research Organizations to deliver biomarker readouts is required.

• Knowledge and track-record of working to GCP principles as part of a clinical study team is required.

• Working knowledge of analytical approaches to biomarker datasets-particularly complex biomarker datasets e.g. genomics datasets (DNA-seq/RNA-seq etc) is required.

• Ability to work on global cross-functional teams is required.

• Ability to influence teams and key stakeholders is required.

• Knowledge and experience of implementing biomarkers in lung and/or head and neck cancer clinical trials is preferred.

• Experience with intra-tumoral therapies including oncolytic viruses is highly preferred.

• Awareness and preferably experience of predictive biomarkers including diagnostic development is preferred.

The anticipated base pay range for this position is $131,000 to $225,400. 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

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .