Director of Biomarker

NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We are seeking a highly motivated and experienced Director of Biomarker to lead the biomarker efforts to support our clinical programs. As Director of Biomarker, you will be responsible for the development and execution of biomarker strategies. The candidate must thrive and adapt to a fast-paced, innovative, and changing environment.

Responsibilities

• Lead cross-functional Biomarker Teams to develop and execute biomarker strategies and to generate, analyze, and interpret data from clinical studies.
• Direct the development, outsourcing, and validation of clinically applicable biomarker assays including pharmacodynamic, predictive, prognostic, safety and other biomarkers for oncology programs.
• Identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers.
• Collaborate with discovery, research, clinical, bioinformatics and biostatistics functions to create synergy in developing biomarker strategies and translational approaches.
• Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in tumor immunology.
• Contribute to company’s scientific literature (publications/presentations).
• Must be able to work independently and effectively on multiple programs in a fast-paced matrixed environment.
• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment.
• Must be team and detail-oriented, motivated, and results focused.

Required education and experience

• PhD and/or post-doctoral training in the area of immunology and/ or oncology
• Minimum of 8 years of directly relevant biotechnology or pharmaceutical industry experience

Qualifications:

• Demonstrated expertise in immunology and/ or oncology clinical development.
• Experience with discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
• Broad understanding of drug discovery and development in both early and late stage development and familiarity with regulatory approval process.
• Analysis and interpretation of biomarker data in preclinical and clinical setting.
• Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.
• Experience with authoring clinical and regulatory documents.
• Knowledge and track-record of working to GCP principles.
• Ability to influence teams and key stakeholders.
• Strong sense of urgency and interpersonal skills.
• Highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic multi-disciplinary environment.

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment