Clinical Research Leader, Neurovascular

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnson MedTech 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.

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Neurovascular Ready to join a team thats reimagining how we heal 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. Learn more at SUMMARY

Under minimal supervision this Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Serves 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 for J&J MedTech Neurovascular;
• Oversees/executes feasibility selection set up conduct and closure of a clinical trial within the allocated countries in accordance with the ICH-GCP applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Develops clinical trial documents (e.g. study protocol informed consents CRF monitoring plan study manual investigator brochure annual reports);
• Ensures applicable trial registration (e.g. on ) from study initiation through posting of results and support publications as needed;
• Manages/oversees ordering tracking and accountability of investigational devices and trial materials;
• Interfaces and collaborates with site personnel IRBs/ECs contractors/vendors and company personnel;
• Interfaces collaborates and oversees Clinical Research Associates (CRAs);
• Oversees and supports the development and execution of Investigator agreements and trial payments;
• Is responsible for clinical data review 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;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing Medical Affairs Regulatory Affairs Health Economics and Market Access R&D etc) contributing to cross-functional alignment;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Is responsible for delivery of assigned clinical projects through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time within budget and in compliance with regulations and SOPs);
• Supports planning track and manage assigned project budgets to ensure adherence to business plans;
• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
• May serve as the clinical representative on a New Product Development team;
• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;
• May conduct review of promotional materials to ensure fair-balance accuracy in clinical claims and messaging;

• Manages and/or mentors 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 as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal State local and company regulations policies and procedures;
• Should develop a strong understanding of the pipeline product portfolio and business needs;
• Generally manages work with limited supervision dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.

• Responsible for communicating business related issues or opportunities to next management level;
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable;
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable;
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures;
• Performs other duties assigned as needed;
• May act as Clinical Safety Coordinator:
  • Coordination of all safety-related activities of clinical trials;
  • Strategic planning and coordination of all new safety initiatives;
  • Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research;
  • Cooperation with the necessary stakeholders (clinical study team medical clinical sites regulatory data management) on safety activities related to clinical studies and guarantee adherence to the SMP;
  • Works with data management to ensure timely database notifications to relevant parties;
  • Coordinates the collection of required information on safety events with the clinical study team;
  • Cooperates 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;
  • Coordinates review of clinical safety data with the clinical study team Medical Affairs or Medical Safety team;
  • Ownership of the study safety inbox and coordination of 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;
  • Assists in scheduling and coordination of safety adjudication process;
  • Coordinates safety board meetings and acts as point of contact for any questions;
  • Ensures all safety reports are directed to the appropriate staff.

EXPERIENCE AND EDUCATION

Education

• Minimum of a Bachelors Degree preferably in Life Science Physical Science Nursing or Biological Science required.

Experience

• BS with at least 6 years MS with at least 5 years 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 (i.e. CCRA CCRC CCRP RAC CDE GCP ISO 14155 MDR MEDDEV).
• Clinical/medical background is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes along with an understanding of 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 clinical/ surgical research setting on time within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Demonstrate competencies in the following area are required:
  • Behave and lead in a professional and ethical manner
  • Advanced project management skills with ability to handle multiple projects

Leadership Competencies:

Ability to lead small study teams to deliver critical milestones as may be assigned.

Leadership required in alignment with J&J Leadership Imperatives:

• Connect Develop strong collaborative relationships with key internal and external stakeholders.
• Shape - Make recommendations for and actively participate and lead in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time within budget and in compliance with SOPs and regulations.

LOCATION & TRAVEL REQUIREMENTS

• Primary location for this position is Irvine CA.
• In-office presence at primary location on a hybrid schedule (2-3 days per week). * At management discretion the position may be performed remotely.
• Ability to travel up to 30% depending on the phase of the program.

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
• Regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.
• Infrequent interaction with regulatory agencies IRB competent authorities may be required in support of clinical strategy discussions.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

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