• Overseeing the day-to-day administrative and operational functions of the business • Improving business procedures • Ensuring compliance with operational policies, objectives, and initiatives • Executing HR activities with recruitment, interview coordination, employee onboarding and training • Developing budget and ensuring financial and operational metrics are met • Reporting directly to the COO

• Serve as clinical science lead for respiratory studies • Act as key contributor to late-stage protocols • Design and develop clinical trial protocols • Drive development of clinical study plans • Interpret clinical data with colleagues • Collaborate with multiple teams to ensure trial execution

At Johnson & Johnson, we believe 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 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America, Remote (US) Job Description: 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 & Johnson, we believe 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 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 https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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 https://www.jnj.com/medtech. JOB 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 www.clinicaltrials.gov) 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; 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 https://www.jnj.com/contact-us/careers . I nternal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Technologically Savvy The anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) • Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment • Develop and finalize the country recruitment/retention strategy • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Generate and utilizes metric reporting to ensure that the study is conducted per plan • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues when necessary • Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines • Manage processes for investigational product (IP) including drug accountability and reconciliation • Support business development and marketing activities as appropriate