Johnson & Johnson Careers
Staff Scientist – Clinical Science and External Research (Neurovascular)
Clinical Research non-MD
Requisition ID: 4554180618
Johnson & Johnson's Family of Companies is recruiting for a Staff Scientist – Clinical Science and External Research, to be located in Irvine, Ca and support our Medical Devices business, and be dedicated to the Cerenovus neurovascular business.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
CERENOVUS is a global leader in neurovascular care. Offering a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke, CERENOVUS is committed to changing the trajectory of stroke.
The Staff Clinical Research Scientist will:
· Be responsible for assigned global post-market investigator-initiated (IIS) or company sponsored Clinical Research Portfolio management within designated Operating Company, as well as, fostering strong, productive relationships with colleagues within the organization.
· Manage the non-regulated studies and low complexity regulated studies, and may lead project teams.
· Assist other leaders with the management of more complex, high-risk studies.
· Manage global post-market non-regulated studies (IIS, Registries, real-world evidence retrospective research, or company sponsored Post-market studies) and provides input and completes clinical tasks with minimal supervision.
· Account for front end activities related to clinical feasibility, site identification and selection, and literature reviews with minimal direction.
· Summarize key product evidence from published literature and provide updates to internal stakeholders on a regular basis
· Participate in formulating evidence generation strategies with input from various functions including Medical Affairs, health economics and outcome research, and global strategic marketing.
· Verify milestones and track payments and budgets for company-managed projects or IIS.
· Develop strong collaborative relationships with Study personnel/investigators and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
· Support the Clinical Research team in publication planning and development and manages IIS publications tracking.
· Possess advanced understanding and maintain current knowledge of regulatory requirements and industry standards on clinical research and publication development.
· Support the implementation of new clinical systems/processes.
· Develop high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs.
· Develop a strong understanding of the neurovascular product portfolio and pipeline.
· Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
· Determine fair market value (FMV) and plan for study budgets or IIS payment structure under direction of senior clinical leaders and in partnership with clinical operation.
· Provide leadership on assigned clinical projects.
· Consistently strive to improve the performance, reputation, and image of the clinical organization.
· Ensure efficient use of resources to provide high quality deliverables.
· Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
· Provide quality feedback to the Directors and Managers of each resource assigned to clinical studies regarding employee performance within the context of the clinical studies.
· Periodically, provide training to employees or other individuals and/or group as needed.
· A minimum of a Bachelor’s Degree with at least 6 years of clinical or related research experience required.
· A Master’s degree OR PhD/MD/ PharmD with 3 years of industry/academic research experience highly preferred.
· A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
· Experience in managing IIS and post-market clinical research highly preferred.
· Knowledge of Good Clinical Practices(GCP) is required.
· Understanding and application of regulations and standards applied in clinical research and publication is required.
· The ability to influence others along with strong written and oral communication skills is required.
· Advanced project management skills with the ability to handle multiple projects required.
· Medical device experience is preferred.
· Experience with medical writing and systematic literature review is required.
· Travel, up to 10%, may be required.
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD