Principal Scientist, SEND Submissions Full-time

Principal Scientist, SEND Submissions

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.

We are searching for the best talent for a Principal Scientist, SEND Submissions to be located in Spring House, PA or La Jolla, CA.

Purpose: The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions. They will serve as the primary point of contact for SEND-related deliverables and issue resolution across internal collaborators and external partners, while ensuring high-quality packages through validation, QC, controlled terminology governance, and continuous process improvement.

You will be responsible for:

• Serving as the Johnson & Johnson Innovative Medicine (JJIM) SEND subject matter expert.
• Functioning as the primary internal and external point of contact for all SEND deliverables, process questions, and issue resolution.
• Monitoring upcoming submissions (using internal JJIM tools) and proactively confirm deliverable needs, timing, readiness, and risks with partners (in conjunction with Nonclinical Writers and Nonclinical Study Leads).
• Collaborating with the Manager of Clinical Data Standards to develop and verify nonclinical Study Data Standardization Plan sections.
• Managing end-to-end nonclinical SEND submission package readiness: study file management, QC, and final package assembly.
• Performing and/or overseeing validation and data quality workflows (dataset review, triage, remediation, and documentation).
• Supporting authoring and QC of nSDRG content to ensure accuracy, completeness, and that the document is reviewer-ready.
• Supporting internal system operations with a variety of repositories, data collection, and SEND generation tools.
• Leading/supporting, as applicable, internal Artificial Intelligence and Machine Learning initiatives.
• Coordinating cross-functional inputs (scientists, Bioanalysis/TK, Histopathology) to deliver compliant SEND artifacts to contract research organizations for incorporation (e.g., PC/PP files, XPT outputs).
• Administering and maintaining SEND Controlled Terminology mappings and metadata updates within JJIM Systems.
• Tracking and reporting team metrics/KPIs; identifying trends and recommending process/tool improvements.
• Coordinating and facilitating bi-weekly SEND team meetings.
• Providing internal leadership with regular status updates and recommendations regarding risks, opportunities, and resourcing.
• Representing the organization in external standards forums (PHUSE/CDISC) and translating the knowledge gained into J&J internal guidance and actions (e.g., SENDIG reviews).
• Contributing to strategic initiatives integrating CRO SEND-ready data into unified systems.
• Overseeing internal FTEs and contractors globally.

Qualifications / Requirements:

Education:

• A minimum of a Bachelor's degree in Toxicology, Pharmacology, Biology, or a related science is required. An advanced degree is preferred.

Experience and Skills:

Required:

• 6+ years of relevant experience is required.
• Background in nonclinical toxicology study data structure and workflows with insight into SEND standard is required.
• Familiarity with regulatory submission requirements and processes is required.
• Knowledge of Good Laboratory Practice is required.
• Familiarity with medical and scientific terminology is required.
• Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions are required, with prior experience in scientific data evaluation, integrated safety assessment, and scientific writing.
• Capable of making fast decisions when necessary, while maintaining positive and inclusive team relationships, is required.
• Personal leadership skills, a proactive and flexible attitude, a sense of urgency, and excellent collaboration skills are required.

Preferred:

• Current participation with industry standards organizations such as CDISC and/or PHUSE is preferred.
• Strong biomedical data management and data standardization skills are preferred.
• Proven ability to build internal and external networks related to SEND processes is preferred.
• Ability to lead teams of scientists and technical staff in a global matrix organization is preferred.

The expected base pay range for this position is $117,000 to $201,250.

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.

• 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)).
• 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.

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/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.

This job posting is anticipated to close on 04/23/2026. The Company may, however, extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.#LI-Hybrid