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.comAs 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 OperationsJob Sub Function: Clinical/Medical OperationsJob Category:People LeaderAll Job Posting Locations:Irvine, California, United States of AmericaJob 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 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 .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 timelinesActs as a key leader from CSER responsible for clinical trial procedures, sponsor management and point of contact for internal and external meetingsLeads 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 availabilityEnforce guidelines and Company policies governing the development of clinical data publications while continuing to look at innovation in publication and scientific communicationsSupports evidence generation strategy , by providing inputs and insightsProvides input to publications, including substantial drafting and editing, as neededProvides status updates on assigned projects for management reviewDevelops 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 partnersSupports congress planning, as needed, including clinical booth activities and scientific sessions coverageSupervises and mentors team members and junior CSER staffHandles budget associated with assigned projectsLeads or participates in monthly literature review with global teams; performs literature review as needed to support EGS and EDSQualifications: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 settingLeadership in managing teams in clinical research or evidence generation strategyAble to influence others along with strong written and oral communication skillsAdvanced project management skills with the ability to prioritize and balance multiple projects ensuring adequate follow throughStrategic mentality and critical analytical skillWorking knowledge of biostatistical methods•Excellent oral, written, and interpersonal communication skillsKnowledge of Good Clinical Practices and ICMJE standardsPreferred:Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferredPre- or Postmarket study design and execution experience including clinical trial managementExperience with medical writing, publication planningOther:This position will be located in Irvine, CA. May require up to 15% travelJohnson & 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 or contact AskGS to be directed to your accommodation resource.#LI-HybridRequired 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 ManagementThe anticipated base pay range for this position is :$137,000.00 - $235,750.00Additional 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Irvine, California, United States of AmericaType: Full time