Associate Director Clinical 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 https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research – Non-MD

Job Category:
People Leader

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

We are searching for the best talent for an Associate Director of Clinical Research located in Irvine, CA and Santa Rosa, CA.

Purpose: This Associate Director Clinical Research will be leading a team of clinical research professionals to manage clinical trials and to develop evidence generation strategies (EGS) for multiple and/or complex projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.  

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: 


* Is responsible for the delivery of assigned clinical programs through effective partnership with internal/external stakeholders (deliver on time, within budget and in compliance with regulations and SOPs);


* Leads a team of clinical research professionals to manage development and execution of clinical trials;


* Leads study design to develop appropriate clinical trials to meet the clinical evidence needs;


* Fosters strong relationships with external physician to support the development and oversight of clinical trials;


* Is responsible for clinical team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel.


* Foster collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g.

Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), facilitating cross-functional alignment;



* Is responsible for communicating business related issues or opportunities to next management level.

Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;


* Develops and oversees assigned project budgets to ensure adherence to business plans; 


* Leads clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review...