Senior Clinical Research Scientist

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 Senior Clinical Research Scientist to support our Electrophysiology business.  This role will work a Flex/Hybrid schedule with 2-3 days per week onsite in our Irvine, CA office .

The Senior Clinical Research Scientist will join the Clinical Science & External Research (CSER) Team responsible for global evidence generation and dissemination of scientific findings from clinical trials and registries sponsored by Johnson & Johnson MedTech Electrophysiology. This associate will play a critical role in the creation and delivery of accurate, high-quality scientific content that communicates clinical and real-world data on the Company’s Electrophysiology medical devices. This role is responsible for running real-world evidence studies and supporting evidence generation strategy. The ideal candidate will have strong scientific writing experience, deep familiarity with the cardiovascular and/or electrophysiology clinical landscapes, and a thorough understanding of clinical trials, regulatory guidelines, and clinical study design.

Key Responsibilities:

Produce clinical study protocols and clinical study reports, ensuring scientific soundness and compliance with regulatory requirements

Conducts literature & landscape reviews to identify concepts of importance to patients to inform evidence strategy

Support and coordinate multiple real-world evidence research studies in partnership with external groups: participating study site staff, Clinical Research Organizations (CRO), and vendors, and with internal teams: medical affairs, data management, biostatistics, data programmers, and regulatory affairs

Manage with supervision clinical trials including study budget assessment, fair mark value appraisal, contract development and execution, payments, and development of study related materials

Ensure clinical research studies follow regulatory standards and maintain accurate, detailed documentation for audits and submissions

Develop and deliver high-quality scientific manuscripts, abstracts, posters, and podium presentations for publication in peer-reviewed journals and presentation at major cardiovascular and Electrophysiology congresses

Collaborate closely with internal cross-functional teams (Clinical, Biostatistics, Medical Affairs, Global Strategic Marketing, Health Economics and Market Access) and external physician authors to ensure accuracy, alignment, and scientific integrity

Analyze and interpret clinical data; effectively communicate data using well-structured tables and visually compelling figures

Support the strategic evidence planning for key products and studies, including first-in-human trials, pivotal studies, indication expansions, post-market surveillances, and registries

Engage with Clinical Science & External Research associates and cross-functional teams to develop evidence strategy

Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in publication and scientific communications

Maintain awareness of emerging trends and competitors in cardiovascular and electrophysiology therapy spaces to inform content development

Stays on top of current scientific data by participating in monthly literature review and sharing key insights with global teams

Qualifications

Required:

Minimum of a bachelor’s degree in Life Sciences, Physical Science, Nursing, Biological Science, or closely related field

Minimum of 2 years of direct involvement in clinical research trials and scientific publications in a medical industry or related setting

Excellent written and oral communication skills

Strong project management skills to balance multiple projects

Excellent interpersonal skills, with the ability to build relationships and collaborate effectively with key partners across different time zones

Demonstrated adaptability in fast-paced, evolving environments

Knowledge of Good Clinical Practices, Evidence Generation Strategy, and ICMJE standards

Preferred:

PhD/MD/PharmD with industry/academic research experience

3+ years of experience in cardiovascular and/or electrophysiology therapeutic areas

Prior experience designing and executing clinical studies

ISMPP CMPP™ or AMWA MWC® credentials

Knowledge of electrophysiology procedures and terminology

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:

Analytical Reasoning, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

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