Director, Pediatric Drug Development

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 ***

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub

Function:

Clinical Development & Research - MD

Job Category:

Scientific/Technology

All Job Posting Locations:

New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America



Johnson & Johnson, is recruiting for a

Director, Pediatric Drug Development

to be located in Raritan, NJ or New Brunswick, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.

This physician will support the Vice President of the Child Health Innovation and Leadership Department (CHILD), a pediatric strategy team within J&J whose mission is to provide advice and leadership to ensure that there is sufficient scientific and clinical evidence to support the safe and effective use of our products in children.

Responsibilities include, but are not limited to the following:

Provide support to all compound development teams regarding pediatric product development including the strategy, creation and review of protocols, and their respective amendments, and regulatory submission such as Proposed Pediatric Study Requests (PPSRs), Pediatric Study Plans (PSPs), Pediatric Investigational Plans (PIPs), and meeting packages prior to submission to regulatory authorities.

Stay abreast of current scientific, regulatory, and operational knowledge of clinical development in children including juvenile animal pharmacology/toxicology and development of pediatric formulations. This knowledge is to be applied in advising teams and the functions that support all therapeutic areas within the company.

Implement the highest ethical standards in the conduct of clinical research in children and comply with pediatric regulatory requirements as they continue to evolve.

Maintain an understanding of internal and external policies relevant to pediatrics, evaluation of innovative approaches and appropriate drug-development tools for clinical research in children as well as providing clinical insights to support business development due diligence.

Identify the barriers to pediatric product development and provide approaches to overcome them, reaching alignment with the diverse stakeholders with a focus toward establishing a sustainable ecosystem that ensures the seamless execution of high-quality pediatric research while advocating for the best interest of children and their parents.

Qualifications:

MD or DO degree or equivalent required

A minimum of 5 years' experience in drug development

A pediatrician with both clinical practice and regulatory experience is strongly preferred

Pediatric drug development experience is an asset, while experience in clinical trial design and conduct within the pharmaceutical industry, CRO or academia is preferred.

Must have the ability to work with cross-functional teams in a matrix organization as is the ability to lead by influence.

Excellent written, oral and presentation skills are required.

The anticipated base pay range for this position is $194,000 to $334,650.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
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Employees and/or eligible dependents may be 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.

Employees may be 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.

Employees are eligible for the following time off benefits:

Vacation - up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found via the following link: ***/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 (***) or contact AskGS to be directed to your accommodation resource.