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.
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
#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
