Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for Principal Scientist/Associate Director, located in Spring House, PA.
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The Heme Malignancies Translational Research (TR) group is seeking an experienced clinical biomarker lead (Principal Scientist/Associate Director) to develop and execute key aspects of Janssen’s translational efforts directed towards the clinical development of novel therapies across multiple areas of disease focus.
The Principal Scientist/Associate Director will provide scientific leadership in preclinical and clinical translational research programs within the Heme TR group. He/she will develop and implement the clinical biomarker strategy for programs in early and late clinical development. Key goals will include determining proof of mechanism, informing and supporting dose, defining pharmacodynamic markers and biomarkers of response and resistance. He/she will need to develop strong collaborations with many functional groups across the Oncology Therapeutic Area (TA), including Discovery expertise in the Discovery and Clinical organizations as needed. Additionally, he/she will develop scientific collaborations external to the organization to develop novel insights from clinical samples into disease biology and segmentation.
Key responsibilities include:
- Manage the translational strategy and implementation for one or more pipeline assets.
- Develop, implement and deliver on the clinical biomarker strategy for the compound, participate in the compound development teams and lead pertinent working groups.
- Lead and guide working groups to implement clinical biomarker and translational research strategy and lead ongoing programs and projects.
- Planning and execution of discovery and validation of predictive, prognostic, safety, and disease biomarkers
- Manage a cross-functional translational research team including junior scientists, lab scientists, computational biologists, and other relevant functions as needed.
- Analyze, interpret and present emerging clinical biomarker data
- Regular reporting of biomarker data to the Compound Development Team and Oncology senior management.
- Responsibility for the biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Report
- Work closely across groups and functions to explore novel indications and new drug combinations for compounds in clinical development.
- Generate pre-clinical experimental plan to support clinical biomarker strategy, oversee/supervise the studies, and integrate into clinical development plan.
- Communicate project deliverables to the leaders across the Oncology Therapeutic Area (TA), and other senior governance groups when necessary.
- Interact and liaise with internal experts, external experts, academic groups, and CROs to establish collaborations and projects.
- Fulfill regulatory responsibilities including preparing, updating, and finalizing regulatory documents.
- You are required to have a Ph.D. or an M.D./Ph.D. in tumor biology, tumor immunology or related field with 5-10 years of experience in a pharmaceutical/biotech setting preferred
- Clinical biomarker and translational research experience is strongly preferred
- Extensive experience in designing and execution of pre-clinical research, in-vitro and in-vivo pharmacology, and mechanism of action studies is required
- Experience in clinical biomarker/translational research is strongly preferred
- Expertise in molecular biology, flow cytometry, genomics, proteomics and analysis of clinical biomarker data strongly preferred
- The candidate must have strong communication skills and sufficient leadership experience in drug discovery and/or early development to represent a diverse TR group on a compound development team (CDT) and to communicate goals and deliverables to senior management and governance committees throughout J&J.
- Excellent written and verbal communication skills required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability