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
Job Description:
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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Clinical Research Leader to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 3 days per week onsite in our Irvine, CA office.
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:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- 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;
- Oversight/execution of 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);
- Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision;
- Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
- Oversee the development and execution of Investigator agreements and trial payments;
- Responsible for clinical data review to prepare data for statistical analyses and publications;
- If applicable, 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) within the assigned projects;
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
- Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
- 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);
- Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
- Track and manage assigned project budgets to ensure adherence to business plans;
- Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
- Develop a strong understanding of the pipeline, product portfolio and business needs;
- May serve as the clinical representative on a New Product Development team;
- May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
- May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
- Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
- Perform other duties assigned as needed;
- Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations.
Education
· Minimum of a Bachelor’s 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 a plus.
- Experience managing projects a plus.
- Medical device experience highly preferred.
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 communication skills;
- Demonstrate competencies in the following area are required:
- Behave and lead in a professional and ethical manner
- Advanced technical writing skills
- 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 to SOPs and regulations.
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. Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
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
