Associate Director, Clinical Science & External Research

Johnson Johnson; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson MedTech Electrophysiology in Irvine, CA is recruiting an Associate Director, Clinical Science & External Research to manage external research programs and publication strategy across the EP business unit. You will work with cross-functional teams to drive evidence generation and publication execution.

The role requires leadership of CSER activities, collaboration with investigators, and oversight of manuscript development and data publication in line with regulatory guidelines.

Qualifications

• Experience leading external research programs and publication development in a medical device or related industry.
• Proven track record supervising personnel in writing and editing manuscripts.
• Knowledge of cardiac arrhythmia medical device industry.
• Familiarity with regulations and guidelines governing clinical trial execution and publication of clinical data.

Responsibilities

• Leads end-to-end management of external research projects, ensuring SOP, GCP, and timelines.
• Serves as CSER lead for clinical trial procedures, sponsor management, and meetings.
• Leads publication plan development and execution with Clinical Research, Biostatistics, and authors.
• Develops and maintains relationships with cross-functional teams and external physician partners.

Skills

External research leadership

Publication development

Team mentoring

Job description

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

Hand