Clinical Science & External Research Manager

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:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

• Johnson & Johnson MedTech Electrophysiology is recruiting for a Clinical Science & External Research Manager to support the Electrophysiology (EP) business unit based in Irvine, CA.

  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 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.

  The Clinical Science & External Research Manager will drive end-to-end evidence generation strategies (EGS). In collaboration with cross-functional teams and research investigators, the CSER manager will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.

  OVERALL RESPONSIBILITIES:

• Handles assigned study programs (investigator Initiated, registries, real-world evidence, collaborative studies)
• Manages the external research program activities including the investigator sponsored trial program ensuring high adherence to SOPs, ICH-GCPs.
• Responsible for new study proposal review, ensures timely decision making and execution of approved studies including while working with external stakeholders
• Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership
• Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps
• Drives publication development with investigators and internally cross functionally with scientific affairs.
• Provides critical scientific input to publications
• Handles assigned studies (investigator Initiated, registries, real-world evidence or company sponsored post-market /premarket collaborative studies)
• Contributes to protocol development of assigned studies
• Provides input to company and investigator sponsored studies’ protocols as needed

• POSITION DUTIES & RESPONSIBILITIES:

   Functional and Technical Competencies:

• Strong project management skills with the ability to balance multiple projects
• Strong scientific capabilities and research background, can think creatively to bring forth new insights and innovative ideas to grow external research collaborations leading to impactful publications and meeting evidence needs.
• Able to influence others along with strong written and oral communication skills
• Strategic mentality and critical analytical skill
• Shown understanding of biostatistical methods
• Successful experience in publication planning and development
• Knowledge of Good Clinical Practices and ICMJE standard
• Leadership in evidence generation strategy

• EDUCATION & EXPERIENCE REQUIREMENTS:

• A minimum of a Bachelor’s or Master's Degree with at least 8 years of clinical, medical affairs or related technical experience.
• PhD/MD/ PharmD with industry/academic research experience preferred.
• A minimum of 1-2 year people management related experience is desirable for this role.
• A Life Science, Physical Science, Nursing, or Biological Science degree preferred.
• Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferred
• Pre- or post-market study design and management experience
• Experience with medical writing and systematic literature review desired
• Develops positive relationship with external researchers and diverse cross-functional teams including Medical Affairs, Biostatistics, clinical research, Compliance, Legal and regulatory to drive timely program execution and success
• Stays on top of current scientific data, leads literature reviews, participates in monthly literature review and shares key insights with global teams
• Oversees budget associated with assigned research projects
• Manages team of study coordinators

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

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