Associate Director, Translational Biology

Role Summary

Responsible for driving the biomarker strategy, companion diagnostic strategy and analysis in clinical biospecimens using Xencor bispecific therapeutics (T cell engagers, immunomodulatory therapeutics). Leads development and execution of biomarker plans and clinical biomarker data analysis, interpretation, and presentation to internal and external stakeholders. Coordinates the analysis of genomics/transcriptomics/immunobiological data for clinical studies and collaborates to maximize the safety and efficacy of Xencor drugs in patients. This position can be based in San Diego or Pasadena, CA, with potential for remote work.

Responsibilities

• Leads development and execution of biomarker plans in the Xencor portfolio
• Responsible for development of biomarker plans and clinical biomarker data analysis, interpretation, and presentation to internal and external stakeholders
• Acts as an independent scientist responsible for coordinating the analysis of genomics/transcriptomics/immunobiological data for clinical studies
• Partnership with colleagues to drive understanding of the biology of Xencor drugs and maximize their safety and efficacy in patients
• Provides ancillary support for clinical biomarkers including program management assistance and expert internal bioinformatics, including a web-based portal dashboard to analyze all clinical endpoints and biomarkers
• Accountable for the oversight and quality of analysis of immunobiological data (flow cytometry/multiplex immunofluorescence/cytokines) for clinical samples and genomics/transcriptomics data for clinical samples
• Plans, implements and manages biomarker projects with outside laboratories
• Champions analysis of genomics/transcriptomics/proteomics for tumor biopsies and peripheral blood samples
• Participates with preclinical projects that drive potential clinical translation including immunological/genomic/transcriptomic analysis of cultured cells or tissues/blood from animal models
• Leads contact on high dimensional data sets, e.g., proteomics/transcriptomics of clinical trials
• Ensures that clinical biomarker data is scientifically rigorous and supports clinical development
• Manages a shared bioinformatician with expertise in programming for high dimensional data sets, e.g., transcriptomics/genomics data; present pre-clinical data and the relevant literature at internal meetings
• Manages a shared translational project manager that assists with communication and contracting with vendor analytic labs
• Contributes to publications and presentations
• Represents supported projects at scientific conferences
• Leads interactions with investigators and cooperative groups
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Performs other duties as required

Qualifications

• Required: Advanced Clinical/Science Degree (PharmD or PhD) with at least 5 years of relevant experience in pre-clinical/translational/clinical drug discovery and development, including CD3 engager or ADC in clinical development.
• Required: Strong understanding of complex cellular signaling pathways.
• Required: Ability to analyze the relationship between proteomic data, flow cytometric data, and immunohistochemistry data in the context of drug candidate administration, clinical response and safety events.
• Required: Knowledge of clinical biomarker analytical labs and CROs; ability to provide clear, direct, and professional guidance and oversight with vendor analytic labs.
• Required: Ability to inspire confidence and teambuilding with internal pre-clinical and clinical teams.
• Required: Highly advanced oral, writing and presentation skills; organized and able to set/meet deadlines.
• Required: Knowledge of international regulations pertinent to current clinical development (e.g., ICH, FDA, EMA); understanding of immunobiology and eagerness to work with cutting-edge clinical immuno-oncology data.
• Required: Ability to work independently as well as collaboratively in a team of people with different backgrounds and seniority levels.
• Required: Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.
• Required: Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.
• Required: Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.
• Preferred: Experience with companion diagnostic development.

Skills

• Strong analytical mindset with ability to integrate multi-omics data with clinical endpoints.
• Experience coordinating cross-functional teams and external vendors; effective communication with investigators and cooperative groups.
• Proven leadership and mentoring capabilities; skilled at coaching and supervising staff per company policies.
• Excellent written and oral communication; demonstrated ability to produce publications and conference presentations.
• Detail-oriented, organized, and capable of managing multiple biomarker programs concurrently.
• Familiarity with regulatory expectations and clinical trial documentation.

Education

• Advanced degree in a relevant field (PharmD, PhD, or equivalent) required.

Additional Requirements

• Occasional travel may be required, including travel between Pasadena and San Diego offices.