Associate Director/Principal Scientist, Translational Biomarkers

Immunome, Inc.•Bothell, WA

About The Position

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. Position Overview The Associate Director/Director, Translational Biomarkers will be responsible for clinical biomarker activities to support Immunome’s drug development programs in oncology. This individual will assume biomarker lead responsibilities such as serving as biomarker representative on study teams, setting up biomarker plans for individual trials and ensuring appropriate collection and timely analysis and reporting of final biomarker data. This person will be a key contributor to the clinical biomarker development and will be responsible for the identification of appropriate vendors/platforms, the establishment and validation of assays, and oversight of data generation. They will ensure appropriate data analysis and interpretation to support decision-making for clinical-stage programs. The successful candidate will have prior oncology clinical experience in biotech/pharma organizations, including interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of therapies to patients in need. This role reports to the Executive Director, Translational Biomarkers.

Requirements

Bachelor’s, Master’s, or Ph.D. degree in a Life Sciences field
A minimum of 10 years of academic or industry experience (or 18+ years with a Master's degree, or 6+ years with a doctoral degree) in clinical biomarkers
Experience with immunohistochemistry (IHC) assay development and validation
Experience in clinical oncology biomarkers and diagnostics as well as awareness of the challenges of implementing diagnostic technologies in the clinical setting
Experience with developing, leading, and executing translational biomarker strategies, such as the transition from discovery research into clinical development
Experience with establishing robust validation plans and execute validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkers
Demonstrated experience supporting clinical development of biomarkers and companion diagnostics
Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment
Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly
High level of initiative and ability to work independently

Nice To Haves

2+ years of leadership experience, preferred

Responsibilities

Designs and implements program-specific early and late development biomarker plans
Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation
Directs the development, outsourcing and validation of clinically applicable companion diagnostic assays for Phase 1 through registrational studies
Provides expertise to development project teams to ensure access to state-of-the art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed companion diagnostic assay
Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
Responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manuals, and interfacing with CROs for execution of services
Prepares and delivers internal and external translational biomarker presentations
Keeps up-to-date on relevant scientific/technical literature and technologies in order to applying external knowledge to internal biomarker and companion diagnostic development as appropriate and collaborates within the team to guide indication and patient selection
Participates in post-hoc biomarker analysis and publication efforts
Supports regulatory submissions and regulatory interactions as needed