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 diagnostic use is in accordance with global regulations and to focus on approval/clearance of assigned devices at all stages of product life-cycle, as needed
• Define priorities and operational tactics.
• Identify emerging trends and disruptions that can be influencing diagnostics in medical health; remain current on the evolving technology landscape and proactively build within JJIM the necessary material changes impacting regulatory decision-making
• Recruiting, interviewing, and selecting top talent
• Collaborate and communicate with BU and TA leadership, product management, commercial, GRA community, R& D teams, Quality, and project teams
• Inspire and live into the GRA Dx vision and strategy
• Be recognized as an inspiring leader (both internal and external) in Diagnostics domains, understand the competitive environment, and maintain active external engagement
• Lead and drive external engagement and effective partnerships for product development teams and to assist in policy shaping.
• Demonstrate leadership with other leaders and building a community of associates with high engagement and performance.

Qualifications:

Required Minimum Education:

• Bachelor’s Degree in Sciences or related field. Preferred advanced degree

Required Years of Related Experience:

• 12+ years' significant professional experience in Regulatory Affairs, epidemiology or related fields.
• People management and building and leading successful teams is required.

Required Knowledge, Skills and Abilities:

• Demonstrated experience contributing to development of innovative diagnostics solutions, delivering diagnostics clinical study or drug development tools or technology for healthcare or clinical trial purposes.
• Strong record of proven leadership. Excellent verbal and written skills is required.
• Knowledge of HA structures and operations, drug development and commercial health care product access channels.
• Proven ability to lead and manage multiple diverse programs and work priorities; ability to effectively interface with senior management, peers, and direct reports.
• Comfortable working in a fast-paced, CREDO based, and matrixed organization
• Understanding regulated industries and its requirements in drug development especially inclusive of diagnostics development tools, technologies and use of medical mobile and patient engaging devices
• Proven track record of delivering projects and developing products
• Ability to actively seek out multiple opinions, yet make independent decisions that influence positive outcomes.
• Ability to work successfully in a matrixed environment

Travel on the Job:

Yes – dependent upon travel policy and restrictions

Percentage Traveled: up to 35%

Type of Travel Required:

Domestic (US), International

People Management Experience: required; at least 3 years

Preferred Qualifications

Preferred Minimum Education: Master or PhD Degree

Preferred Area of Study: molecular science, health science, diagnostics health technology training

Preferred Related Industry Experience (if applicable): Diagnostics Pharmaceutical, health authority, medical device, Healthcare; Understanding of regulated industries and regulatory requirements in drug development.

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

Anticipated base salary is between $193, 000 and $333, 500 in the US.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits