Company: Johnson & Johnson Location: , Employment Type: Full Time Date Posted: 07/31/2021 Expire Date: 09/29/2021 Job Categories:
Biotechnology and Pharmaceutical, Healthcare, Other, Healthcare, Practitioner and Technician, Executive Management, Quality Control, Research & Development, Medical
Janssen is seeking a highly motivated individual to join the Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, he/she will be accountable for implementation and execution of clinical sample collection, testing and data delivery activities for both early and later phase clinical programs in oncology. The successful candidate will have experience bridging both science and operations though cross functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.
Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology
Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout
Work effectively with procurement and scientific leads to execute contracts and statement of work to meet program deliverables
Contributes to central lab setup and management throughout the course of a study
Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are, processed, tested and data is reported to meet development timelines and specifications
Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs
Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials
Works with scientific stakeholders to identify innovative biosample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards
Develops presentations and presents sample tracking/testing metrics at regular team meetings
May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program
Manages relationships with internal and external partners to ensure on time and quality deliverables
Participates in cross-functions study team meetings across clinical, translational research and diagnostics
Life Science degree (Bachelor Minimum) in scientific, medical or healthcare area required. Additional qualifications: e.g. MS, PhD and/or project management certification desirable.
5+ years of work experience in a clinical development, diagnostics and/or Pharmaceutical/biotech R&D
Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required
Project management experience is preferred
Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred
Excellent written and verbal communication skills
Ability to effectively and collaboratively work on global cross-functional teams
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.
Primary Location United States-Pennsylvania-Spring House-1400�McKean�Road Other Locations United States-California-South San Francisco, North America-United States Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105954465W