The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Clinical Research Scientist aligned to Biosense Webster, Mentor and Acclarent, located in Irvine, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
If you want to work with a dynamic team in a fast-paced, challenging and highly collaborative environment focused on delivering market-leading innovations worldwide, we invite you to learn more about the CSS Group and our Johnson & Johnson Family of Companies. Our therapies touch the lives of millions of patients every year and our robust and innovative pipeline continues to deliver on the promise of impacting even more patient lives. Be part of a growing organization that is focused on providing exciting opportunities for employees to expand their knowledge, skills and experience to help ensure continued career growth and development. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admired corporations in the world.
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat. Learn more about Acclarent at www.acclarent.com
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more at Biosense Webster at www.biosensewebster.com
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at www.mentorwwllc.com
Codman Neuro is a global neurosurgery and neurovascular company that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Learn more about Codman Neuro at www.codman.com for more information.
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.
• He/she will be responsible for the management of non-regulated studies and low complexity regulated studies, and may lead project teams. He/she may 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.
• Be responsible 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 assigned Operating 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 Operating Company 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.
• May be asked to provide training to employees or other individuals and/or group as needed.
• A minimum of a Bachelor’s Degree
• A minimum of at least 6 years of clinical or related research experience is 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 highly preferred
• This position will be located in Irvine, CA and may require up to 10% travel.Primary Location
Biosense Webster Inc. (6010)Job Function
Clinical Research non-MD