aspects of Oncology's translational efforts directed towards the clinical development of novel cell therapies across multiple areas of disease focus.
The incumbent will provide scientific leadership in translational research programs in clinical and post-marketing settings with a focus on cell therapies and associated safety signals. To this end this colleague will be expected to develop strong collaborations and influence across the Oncology Therapeutic Area, leveraging expertise in the Discovery, Clinical, and Commercial organizations as needed. Additionally, the incumbent will be expected to develop scientific collaborations external to the organization to develop novel insights from clinical samples into disease biology and segmentation. This colleague will also conduct/support communications with physicians and regulatory agencies as needed. Details of the role include but are not limited to:
Lead working groups to conduct translational investigations of cell therapy products, with specific focus on safety signals
Develop and implement the translational strategy for the compound, participate in the compound development team and pertinent working groups
Develop, implement, and deliver on translational collaborations and projects, including initial proposal development, planning timelines and resources, monitoring milestones and final deliverables
Communicate project deliverables to the leaders across the Oncology therapeutic area (TA) leaders, senior governance groups, external collaborators, and physicians when necessary
Interact and liaison with internal experts, external experts, academic groups, and CROs to establish collaborations and projects
Fulfill regulatory responsibilities including preparing for regulatory meetings and drafting scientific sections for regulatory documents that contain data from translational research
Ph.D. with experience in oncology and/or immuno-oncology is strongly preferred, a masters degree is required
At least five years of applicable translational, biomarker or clinical trial research experience is required, preferably in an industrial setting. Experiences in cell therapy is a plus.
Familiarity with the techniques common to translational research including, but not limited to, flow cytometry, ELISA-based assays, genomics, and proteomics.
Strong computational skills in analyzing -omics datasets (e.g. transcriptomic, genetic, proteomic) and expertise in predictive algorithms and/or diagnostic development is strongly desired.
Relevant experience in clinical biomarker, safety, and drug discovery is desired
Strong publication record in oncology is highly preferred
Experience in managing multi-faceted projects and programs is preferred
Strong communication and writing skills are required
Johnson & Johnson Innovative medicine 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.