Clinical Research Leader

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

About the role

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a proud heritage of continually elevating standards of care for neurovascular stroke patients. Your unique talents will help patients on their journey to wellness.

Responsibilities

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones.
• Oversee and execute feasibility, selection, setup, conduct, and closure of clinical trials within allocated countries, adhering to ICH-GCP, applicable legislation, and Company Standard Operating Procedures.
• May serve as the 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 applicable trial registration (e.g., on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
• Manage and oversee ordering, tracking, and accountability of investigational devices and trial materials.
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Interface, collaborate, and oversee Clinical Research Associates (CRAs).
• Oversee and support the development and execution of Investigator agreements and trial payments.
• Review clinical data to prepare data for statistical analyses and publications.
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits, or close-out visits based on study need.
• Contribute to the development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), fostering cross-functional alignment with partners such as Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, and R&D.
• Provide on-site procedural protocol compliance and data collection support to clinical trial sites.
• Contribute to the critical assessment of literature and interpretations and dissemination of all evidence generated.
• Deliver assigned clinical projects through effective partnership with the study core team, ensuring projects are on time, within budget, and in compliance with regulations and SOPs.
• Support planning, tracking, and managing assigned project budgets to ensure adherence to business plans.
• Support clinical scientific discussions with regulatory agencies/notified bodies to drive clinical and regulatory strategy.
• May serve as the clinical representative on a New Product Development team.
• Assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within defined timelines and review/update at planned intervals.
• Maintain an overview to ensure (study) commitments are timely and properly met by coordinating specific documentation and contributing to cross-functional review of associated documents.
• Conduct reviews of promotional materials to ensure fair balance, accuracy in clinical claims, and messaging.
• Manage and/or mentor resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
• Function as a reliable, trusted resource of accurate, up-to-date project knowledge for key stakeholders.
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Develop a strong understanding of the pipeline, product portfolio, and business needs.
• Communicate business-related issues or opportunities to the next management level.
• Follow all company guidelines related to Health, Safety, and Environmental practices.
• For those who supervise or manage staff, ensure subordinates follow all company guidelines related to Health, Safety, and Environmental practices.
• Perform other duties as assigned.
• May act as Clinical Safety Coordinator:
  • Coordinate all safety-related activities of clinical trials.
  • Strategic planning and coordination of all new safety initiatives.
  • Develop clinical study safety management plans (SMP) and study-specific safety flows in accordance with internal procedures and applicable safety regulations for clinical research.
  • Cooperate with necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and ensure adherence to the SMP.
  • Work with data management to ensure timely database notifications to relevant parties.
  • Coordinate the collection of required information on safety events with the clinical study team.
  • Cooperate with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study.
  • Coordinate review of clinical safety data with the clinical study team, Medical Affairs, or Medical Safety team.
  • Own the study safety inbox and coordinate timely reporting of study adverse events to competent authorities and ethics committees.
  • Create safety reports for reporting to internal stakeholders, investigators, ethics committees, and authorities.
  • Assist in scheduling and coordination of the safety adjudication process.
  • Coordinate safety board meetings and act as the point of contact for any questions.
  • Ensure all safety reports are directed to the appropriate staff.

Requirements

• Minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science, or a closely related degree.
• BS with at least 6 years, MS with at least 5 years, or PhD with at least 3 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Experience working well with cross-functional teams is required.
• Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
• Clinical/medical background is a plus.
• Medical device experience is highly preferred.

Skills

• Good understanding of clinical research science and processes, along with product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects.
• Proven track record in delivering clinical projects within a clinical/surgical research setting, on time, within budget, and in compliance with SOPs and regulations.
• Strong presentation and technical writing skills.
• Strong written and oral English communication skills.
• Advanced project management skills with the ability to handle multiple projects.
• Professional and ethical behavior and leadership.

Johnson & Johnson provides an inclusive work environment where each person is considered as an individual and recognized for their merit.

Pay

The anticipated base pay range for this position is $109,000.00 - $174,800.00.