Clinical Research Leader, Neurovascular

Overview

Johnson & Johnson Med Tech, Neurovascular, is recruiting a Clinical Research Leader, Neurovascular to join our team. This position is located in Irvine, CA. At management discretion, the position may be performed remotely.

Johnson & Johnson believes health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs of tomorrow and profoundly impact health for humanity.

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Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Clinical Development & Research – Non-MD

Job Category: Scientific/Technology

Location: Irvine, California, United States of America;
Remote (US) possible

Johnson & Johnson Med Tech, Neurovascular, is recruiting a Clinical Research Leader, Neurovascular to join our team. This position is located in Irvine, CA. At management discretion, the position may be performed remotely. The Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a heritage of elevating standards of care for neurovascular stroke patients.

Your unique talents will help patients on their journey to wellness.

• Lead and support one or several clinical trials within the Clinical R&D Department, fostering strong relationships across the organization.
• Execute and manage company-sponsored clinical trials, ensuring timelines and study milestones are met in accordance with ICH-GCP and SOPs.
• Oversee feasibility, selection, setup, conduct and closure of clinical trials in allocated countries.
• May serve as primary contact for clinical trial sites (e.g., site management).
• Develop clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
• Ensure trial registration (e.g., Clinical Trials.gov) from study initiation through posting of results and publications as needed.
• Manage investigational devices and trial materials; interface with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Oversee Clinical Research Associates (CRAs) and contribute to Investigator agreements and trial payments.
• Data review to prepare data for statistical analyses and publications; perform monitoring activities as needed.
• Contribute to global evidence generation strategies and cross-functional alignment with partners (e.g., Regulatory Affairs, Medical Affairs, Global Marketing, R&D).
• Support PMCF plans and reports; ensure commitments are met and documentation is coordinated across functions.
• Contribute to literature assessment, evidence interpretation and dissemination.
• Manage project budgets and deliver clinical projects on time, within budget, and in compliance with regulations.
• Support regulatory discussions and may serve on a New Product Development team.
• Coordinate safety activities as Clinical Safety Coordinator when applicable.
• Coordinate safety reporting, safety board meetings, and timely reporting to authorities and ethics committees.

Education: Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science.

Experience: BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred. Previous clinical research experience required. Experience with cross-functional teams and industry certifications (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV) preferred. Medical device experience highly preferred.

• Strong understanding of clinical research processes, product development, and global trial regulations; ability to provide strategic clinical input across NPD and LCM projects.
• Proven track record delivering clinical projects on time and within budget; strong written and oral communication skills.
• Experience with cross-functional…