Senior Director, GRA Leader Diagnostics (Dx)

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:

Regulatory Science

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Senior Director, GRA Leader Diagnostics (Dx). Preferrably this role will be based in either Raritan, NJ (preferred) or Spring House, PA.

About Johnson & Johnson 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

Purpose

The Senior Director, GRA Leader Dx is the regulatory leader and co-creator of GRA’s Dx current and future state by setting clear objectives, developing plans and road maps, and implementation through coordination with key stakeholders (GRA, Therapeutic Areas (TAs), R&D, Commercial, and collaboration with external partners).  Oversees the development and drives execution of effective and progressive diagnostic and companion diagnostic (CDx) product regulatory strategies for early and late development project teams, within clinical studies, and through the transition to mature commercial products.   Creates and continuously develops a best-in-class GRA Dx team by providing deeper insights, strengths, and skills complementing the team’s regulatory expertise and establishing the optimal team operating model that improves GRA Dx’s role supporting Janssen’s product innovation.   The Senior Director GRA Leader Dx is a key representative for interactions with regulatory agencies by defining regulatory expectations for teams, positions response for regulatory agencies, and assures successful negotiations of strategies and execution.

Major Duties & Responsibilities

• Effectively lead the vision and strategy for the GRA Dx function to maximize business opportunity
• Lead the GRA Dx team for all global regulatory activities associated with the strategy, registration and maintenance of new and approved medical device products across J&J Innovative Medicine (JJIM) TAs.
• Leads GRA Dx team to offer advice, consultations,and training to internal and extenal stakeholders on current global state of diagnostics regulations and guidelines.
• Keep abreast of evolving diagnostics state-of -the-art information, global regulations, and best practices to be able to assist with identifying and evaluating solutions that enhance drug development programs.
• Manages key stakeholders across JJIM.
• Support or lead Due Diligence activities.
• Responsible for team’s staffing, organizational structure and functional, and project distribution management decisions.  Effective handling of employee relations and authority to hire personnel within the reporting structure.
• Accountable for delivery of consistent high quality strategic decisions, direction, and advice commensurate with business requirements and priorities. Develops regulatory strategic objectives, goals, and performance measures.

Other Duties

• Develop and maintain standard procedures to support GRA Dx, as needed
• Assure personnel and sponsor’s meeting attendees are prepared for interactions with global health authorities.
• Effectively assess and manage risk opportunities. Communicate results to senior leaders and other stakeholders.
• Direct and oversee the preparation, accuracy, messaging, and completeness of regulatory submissions that support business portfolio
• With a focus on medical devices and therapeutics, assure development of drugs, devices and clinical trial enabling