Associate Director, Oncology Translational Research, Hematology
About The Position
Johnson & Johnson Innovative Medicine’s Heme Translational Research group is seeking an experienced clinical biomarker lead to advance translational research for novel therapies, particularly within multiple myeloma. The Associate Director will serve as a translational research leader for specific programs, participate on Compound Development Teams within the Multiple Myeloma Disease Area Stronghold, and lead disease-related projects that advance scientific understanding of multiple myeloma. The role provides scientific leadership across preclinical and clinical translational research and develops and implements 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 Associate Director 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.
- 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 diverse 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 an industrial setting.
- Experience in clinical biomarker or translational research, especially in late development programs.
- Experience running multifaceted projects and programs.
Responsibilities
- Manage the translational strategy and implementation for one or more pipeline assets.
- Plan and execute discovery and validation of predictive, prognostic, safety, and disease biomarkers.
- Develop, implement, and deliver the compound’s clinical biomarker strategy; participate on 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 a cross-functional translational research team, including junior scientists, laboratory scientists, computational biologists, and other relevant functions.
- Analyze, interpret, and present emerging clinical biomarker data.
- Regularly report biomarker data to Compound Development Teams and Oncology senior management.
- Prepare and oversee biomarker sections of clinical protocols, Investigator Brochures, Compound Development Plans, and Clinical Study Reports.
- Coordinate proposed analyses within clinical trials, including in-house coordination where applicable.
- 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 findings into clinical development plans.
- Communicate project deliverables to Oncology Therapeutic Area leaders and other senior governance groups as needed.
- Liaise with internal and external experts, academic groups, and contract research organizations to establish collaborations and projects.
- Fulfill regulatory responsibilities, including preparing, updating, and finalizing regulatory documents.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
