Director, Immuno-Oncology - Biomarker Research

Coherus is seeking an experienced and exceptional Director, Immuno-Oncology - Biomarker Research to support Immuno-Oncology therapeutic area. The successful candidate will work in a dynamic multidisciplinary matrixed team environment to support both early and late stage clinical programs. This position will be responsible for the evaluation of biomarker and CDx strategies for programs in solid tumors.
The scientist will provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluate their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker and/or diagnostic assays. This will include input on clinical protocols and associated documents as well as participation in meetings with regulatory authorities. In addition, the scientist will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, and other biomarkers) and design, implement and oversee biomarker and diagnostic testing and data analysis together with the functional area representatives. The successful candidate will lead cross functional teams to achieve these aims. The candidate will also work closely with our external co-development partners in immuno-Oncology R&D.
Coherus is a cross collaborative environment and the ability to work effectively across these groups is a key attribute for this role. Experience in evaluating and executing biomarker and CDx strategy in clinical stage programs in immuno-Oncology field and a strong understanding of clinical development in solid tumors are highly desired.

Responsibilities

Lead cross-functional Biomarker Teams to develop and execute biomarker/diagnostic strategies and to generate, analyze, and interpret data from clinical studies
Direct 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. Will be working closely with data scientists
Collaborate with Research Biology, Clinical Research, Bioinformatics and Biostatistics functions to create synergy in developing biomarker strategies and translational research for IO combination therapy approaches
Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in tumor immunology
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

Qualifications

PhD/MD and/or post-doctoral training in the area of immunology and/ or oncology or other related medical science field with a minimum of 10 years of directly relevant biotechnology or pharmaceutical industry experience
Understanding biomarker signatures related to IO drugs
Candidate must be detail-oriented with excellent organizational skills
Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic multi-disciplinary environment
Ability to integrate complex scientific ideas, generate testable hypotheses, and execute
Analysis and interpretation of biomarker data in clinical setting including cross-validation requirement
Broad understanding of drug discovery and development in both early and late stage
development and familiarity with regulatory approval process
Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics
Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers including multi-omics, and MoA/translational research
Authoring of biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents
Broad experience in technical aspects of companion diagnostics development and validation
Strong verbal and written communication skills
Understanding of IP, contracting terms and provisions