Associate Director, Clinical Science & External Research

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: 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. 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 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 Johnson & Johnson is an Equal Opportunity Employer. All qualified