Distinguished Scientist, Nonclinical Safety Leader Full-time

Distinguished Scientist, Nonclinical Safety Leader

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.

We are searching for the best talent for a Distinguished Scientist, Nonclinical Safety Leader in San Diego, CA. Purpose: Do you enjoy working on complex biological problems? Are you ready to combine your drive, scientific curiosity, enthusiasm, and drug development expertise to make a lasting impact on the world? As a Distinguished Scientist, Nonclinical Safety Lead (NCSL) you will collaborate with innovative and diverse scientists to support projects in our large and varied portfolio that spans multiple therapeutic areas and includes innovative modalities. In this vital role you will provide toxicology leadership for all aspects of discovery and development projects, with flexibility to specialize or work across stages of development, therapy areas, and modalities.

The NCSL will collaborate with discovery scientists to identify and nominate candidate molecules, and with development teams bring these molecules to humans and ultimately through global registration. You will be responsible for:

• Leading PSTS project teams of nonclinical safety and PK scientists, ensuring efficient information transfer within the team.
• Serving as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management.
• Creating target risk assessments and developing plans to screen for and mitigate potential risks; analyzing toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments.
• Contributing to issue-resolution teams by generating hypotheses and investigative strategies.
• Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations.
• Participating in medical safety teams, signal detection analyses, and risk mitigation strategies.
• Engaging in nonclinical safety risk assessments for due diligence of potential L&A opportunities.
• Collaborating proactively with CMC functions to assure drug substance quality.
• Actively participating in external academic or industry societies and consortia to enhance toxicology strategies and capabilities.
• Maintaining scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects.
• Communicating effectively with stakeholders, including regulatory authorities, leveraging drug development experience.
• Providing leadership and mentorship within the PSTS organization.
• Leading strategic initiatives as required.

Qualifications/Requirements:

• Education: Minimum of a Doctoral degree (PhD, DVM, MD, or equivalent) in toxicology, pharmacology, or related field with approximately 10+ years of relevant pharmaceutical/biotech experience is required.
• Proven experience in representing toxicology/nonclinical safety on multi-disciplinary project teams.
• Excellent oral and written communication skills.
• Strong understanding of the drug discovery and development process.
• Preferred: Experience in conducting due diligence activities.
• Preferred: Previous role as a Study Director/Study Monitor under Good Laboratory Practice regulations.
• Preferred: Familiarity with various therapeutic modalities.
• Preferred: Board certification (e.g., DABT).

The anticipated base pay range for this position is: $164,000.00 – $282,900.00. 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 Colorado –48 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 Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.