Associate Director, Clinical Science & External Research

Johnson & Johnson MedTech; Irvine (CA); On-site; USD 137,000 - 236,000; Full time

Job summary

Johnson & Johnson MedTech is seeking an Associate Director of Clinical Science & External Research in Irvine, CA. This role drives external research programs, manages clinical trials and post-market studies, and leads publication strategy to generate evidence for the Electrophysiology pipeline.

The candidate will oversee manuscript development, collaborate with cross-functional teams, and mentor CSER staff while engaging international collaborators and regulators as needed.

Qualifications

• Bachelor’s or Master’s in life sciences with 10–12 years of clinical/medical affairs experience.
• PhD/MD/PharmD with 8–10 years of industry/academic research experience.
• Experience leading clinical research or evidence generation strategy.

Responsibilities

• Leads end-to-end management of external research projects ensuring SOPs, GCPs and timelines.
• Acts as CSER lead for clinical trial procedures and sponsor management.
• Leads publication plan development and cross-functional publication execution.
• Mentors CSER staff and manages budgets.
• Builds relationships with cross-functional teams and external physician partners.

Skills

Clinical research

Publication planning

Medical writing

Team leadership

GCP

ICMJE standards

Biostatistics

Education

Master’s or PhD in Life Sciences/Physical Sciences

MD/PharmD/PhD

Job description

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 managementExperience 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 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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