Preclinical Research Associate Director

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

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Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Preclinical Evidence & External Partnerships Associate Director. This position is located in Irvine, CA and will be following a hybrid model.

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.

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

Purpose: The Preclinical Evidence & External Partnerships Associate Director will drive pre-market evidence generation strategies (EGS) and physician collaborations. In collaboration with cross-functional teams and external research investigators, this role will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.

You will be responsible for:

• Ideates preclinical evidence strategies to support first-in-human use for all portfolio programs
• Manages the preclinical external research program and physician partnerships in coordination with cross-functional clinical science partners
• Responsible for new study proposal review, ensures timely decision making and execution of approved studies including while working with external stakeholders
• Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership
• Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps
• Drives publication development with investigators and internally cross functionally with scientific affairs partners.
• Provides critical scientific input to publications
• Contributes to preclinical protocol development for all portfolio products
• Provides input to external physician partners on proposed preclinical research plans

Qualifications / Requirements:

• Minimum of a Bachelor’s degree in Biological Science or a related discipline is required; Advanced degree (Master’s or PhD) is strongly preferred.
• At least 8+ years of related scientific and technical experience, including leadership or management role within Medical Affairs or a similar role is required.
• A minimum of 2 years of people management-related experience is required.
• Experience working in Cadiovascular, Electrophysiology, or Structural Heart is strongly preferred.
• Expertise in preclinical science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and clinical trial regulations is required.
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including IDE/510(k)/De Novo/PMA and/or their global counterparts) is highly desired.
• Ability to lead a team of preclinical scientists to provide strategic and scientific research input across NPD projects is required.
• Proven track record of contributing to medical programs on time, within budget and in compliance to SOPs and regulations is required.
• Up to 25% domestic and international travel may be required.

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