Associate Director, Oncology Translational Research, Hematology

Johnson & Johnson•Spring House, PA

1d•Hybrid

About The Position

Johnson & Johnson Innovative Medicine’s Heme Translational Research group is seeking an experienced clinical biomarker leader to develop and execute translational research supporting clinical development of novel therapies. The Associate Director will serve on Compound Development Teams within the Multiple Myeloma Disease Area Stronghold and lead disease-related internal and external projects to advance scientific understanding of multiple myeloma. The role provides scientific leadership for preclinical and clinical translational research, including development and implementation of clinical biomarker strategies for programs in early and late clinical development. The work includes determining proof of mechanism, informing and supporting dose selection, and defining pharmacodynamic markers and biomarkers of response and resistance. The position collaborates across Oncology Discovery and Clinical organizations and develops external scientific collaborations to generate insights from clinical samples into disease biology and segmentation.

Requirements

Ph.D. or M.D./Ph.D. in molecular biology or a related field.
At least 5–10 years of applicable biomarker, translational research, program management, clinical trial, and/or research experience; industrial experience is preferred.
Strong background in tumor biology, project management, and laboratory management.
Five or more years of pharmaceutical or biotechnology industry research experience.
Extensive experience designing and executing preclinical research, in-vitro and in-vivo pharmacology, and mechanism-of-action studies.
Familiarity with translational research techniques, including flow cytometry, genomics, proteomics, and data analysis.
Strong communication skills and sufficient leadership experience in drug discovery and/or early development to represent a translational research group on a Compound Development Team and communicate goals and deliverables to senior management and governance committees.
Excellent written and verbal communication skills.

Nice To Haves

Multiple myeloma experience.
Experience in clinical biomarker or translational research, especially in late development programs.
Experience running multifaceted projects and programs.

Responsibilities

Manage translational strategy and implementation for one or more pipeline assets.
Plan and execute discovery and validation of predictive, prognostic, safety, and disease biomarkers.
Develop and deliver clinical biomarker strategies; participate in Compound Development Teams and lead relevant working groups.
Guide working groups in implementing clinical biomarker and translational research strategies, and lead ongoing programs and projects.
Manage cross-functional translational research teams, including junior scientists, laboratory scientists, computational biologists, and other relevant functions.
Analyze, interpret, and present emerging clinical biomarker data.
Report biomarker data regularly to Compound Development Teams and Oncology senior management.
Own biomarker sections of clinical protocols, Investigator Brochures, Compound Development Plans, and Clinical Study Reports.
Coordinate proposed analyses within clinical trials.
Meet compliance requirements and projected timelines for project deliverables, including protocol outlines, protocols, informed consent documents, strategy documents, and analysis reports.
Work across groups and functions to explore novel indications and drug combinations for compounds in clinical development.
Generate preclinical experimental plans, oversee or supervise studies, and integrate results into clinical development plans.
Communicate project deliverables to Oncology Therapeutic Area leaders and senior governance groups as needed.
Liaise with internal and external experts, academic groups, and CROs to establish collaborations and projects.
Prepare, update, and finalize regulatory documents.