Director, Early Development, Global Clinical Operations

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:

Enterprise Management

Job Sub Function:

R&D Management

Job Category:

People Leader

All Job Posting Locations:

La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Director, Early Development, Global Clinical Operations to be located in Spring House, PA; Titusville, Raritan, NJ or La Jolla, CA.

Purpose: The Director Early Development (ED), Global Clinical Operations (GCO) is accountable for defining the strategy and operational management of trial coordination and site management activities of the GCO ED team in the countries within the region. The candidate will ensure the successful country and regional execution of early development and clinical pharmacology (ED&CP) trials, including resource allocation, adherence to timelines and budget, compliance with all GCO SOPs, policies and regulatory requirements. 

The candidate is responsible for the line management and the development of their staff, e.g.

Functional Managers (FM), Trial Managers (TM), Site Managers (SM), Site Strategy Leads (SSL), Clinical Trials Assistants (CTA) and any other GCO ED&CP staff in their reporting line.

The candidate  supports Human Resources development programs which include Performance and Development management, talent management and training requirements. The candidate ensures alignment of goals with organizational and assigned trial objectives. 

For countries where the staff involved in early development and clinical pharmacology trials do not report into the Director Early Development, the accountability for delivery of early development and clinical pharmacology trials is shared with the respective GCO country heads. For these countries the Director Early Development is responsible for ensuring that these countries fulfill the criteria needed for conducting early development and clinical pharmacology trials and has oversight responsibilities for the conduct and delivery of these trials. 

As member of the GCO Early Development Community of Practice and GCO Regional Leadership Team, he/she will be responsible for contributing to the development of the GCO ED strategy, contribute to overall GCO strategy, develop capabilities and implementation of innovative creative solutions. 

Reports to the VP GCO for the Region.

You will be responsible for:

• Define the GCO ED strategy for the region, aligned with GCO and R&D strategies, to set up the GCO ED team for success. 
• Overall accountability for the planning, preparation, execution and close out of early development and clinical pharmacology clinical trials in the region. 
• Ensures all operational objectives are met in compliance with all relevant ICH-GCP regulations, guidelines including Health Care Compliance, internal SOPs, Work Instructions, and Policies. 
• Appropriate and timely escalation of issues to GCO leadership. Report (suspicion) of fraud or scientific/ethical misconduct. 
• Ensures that GCO ED Functional Managers have proper connectivity with the local Health Authority agencies for activities related to GCO early development and clinical pharmacology trials. 
• Authorized representative to sign contracts, agreements, and PO’s. 
• Accountable for local and/or regional annual budget process in compliance with financial processes (i.e., reporting) and responsible for maintenance of the Affiliate Funding contract. 
• Member of GCO Regional Leadership T