Job Function: R&D Operations
Job Sub Function: Clinical/Medical Operations
Job Category:People Leader
All Job Posting Locations:Irvine, California, United States of America
Job Description:Johnson & Johnson MedTech Electrophysiology is recruiting for an
Associate Director, Clinical Science & External Research to support the Electrophysiology (EP) business unit based in
Irvine, CA.The
Associate Director, Clinical Science & External Research (CSER) will drive end-to-end management of the external research programs with clinical trials and post market studies sponsored by Johnson & Johnson MedTech Electrophysiology to generate clinical evidence for the company's pipeline that impacts patient lives. In collaboration with cross-functional teams and study investigators, this leader will support execution of the evidence generation strategy through external research clinical strategy development, execution, craft and implement publication plans, lead all aspects of the development of scientific presentations and publications, . This role will have broad reach and visibility with international team members!
The candidate for this position has shown success in the external research and publication development in a medical device or related industry, is proficient in supervising personnel writing and editing manuscripts, is knowledgeable of the cardiac arrhythmia medical device industry, and is familiar with pertinent regulations and guidelines governing clinical trial execution and clinical data publication.
Key Responsibilities:
- Leads end to end management of assigned external research projects ensuring compliance to SOPs, GCPs and study timelines
- Acts as a key leader from CSER responsible for clinical trial procedures, sponsor management and point of contact for internal and external meetings
- Leads publication plan development as well as execution in partnership with Clinical Research, Biostatistics and physician authors. Works with Clinical Study Team on data timelines to create long-term forecasting for data availability
- Enforce guidelines and Company policies governing the development of clinical data publications while continuing to look at innovation in publication and scientific communications
- Supports evidence generation strategy , by providing inputs and insights
- Provides input to publications, including substantial drafting and editing, as needed
- Provides status updates on assigned projects for management review
- Develops positive relationships with diverse cross-functional teams including Medical Affairs, Data Science, Health Economics and Market Access, Global Strategic Marketing, Education, Communications, etc.
- Develops subject matter knowledge and leads external scientific discussions and builds positive relationships with external physician partners
- Supports congress planning, as needed, including clinical booth activities and scientific sessions coverage
- Supervises and mentors team members and junior CSER staff
- Handles budget associated with assigned projects
- Leads or participates in monthly literature review with global teams; performs literature review as needed to support EGS and EDS
Qualifications:Education:- A minimum of a Bachelor's or Master's Degree with at least 10-12 years of clinical, medical affairs or related technical experience, OR PhD/MD/ PharmD with 8-10 years of industry/academic research experience preferred. A Life Science, Physical Science, Nursing, or Biological Science degree.
Required:- Minimum of 5+ years of clinical research, clinical publication planning and writing experience in a medical industry or related setting
- Leadership in managing teams in clinical research or evidence generation strategy
- Able to influence others along with strong written and oral communication skills
- Advanced project management skills with the ability to prioritize and balance multiple projects ensuring adequate follow through
- Strategic mentality and critical analytical skill
- Working knowledge of biostatistical methods
- Excellent oral, written, and interpersonal communication skills
- Knowledge of Good Clinical Practices and ICMJE standards
Preferred:- Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferred
- Pre- or Postmarket study design and execution experience including clinical trial management
- Experience with medical writing, publication planning
Other:- This position will be located in Irvine, CA. May require up to 15% travel
#LI-Hybrid
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Developing Others, Fact-Based Decision Making, Good Clinical Practice (GCP), Inclusive Leadership, Innovation, Laboratory Operations, Leadership, Operational Excellence, Program Management, Research and Development, Research Ethics, Team Management, Vendor Management
The anticipated base pay range for this position is :$137,000.00 - $235,750.00
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
