Senior Principal Scientist, Nonclinical Safety Leader
About The Position
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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About 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 We are searching for the best talent for Senior Principal 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 Senior Principal 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.
Requirements
- A minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline is required.
- A minimum of 12 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or a minimum of 8 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a doctoral level degree (PhD, DVM, MD or equivalent) is required.
- 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.
Nice To Haves
- Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
- Experience in conducting due diligence activities.
- Previous role as a Study Director/Study Monitor under Good Laboratory Practice regulations.
- Familiarity with various therapeutic modalities.
- Board certification (e.g., DABT).
Responsibilities
- Lead PSTS project teams of nonclinical safety and PK scientists, ensuring efficient information transfer within the team.
- Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management.
- Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments.
- Contribute 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
- Participate in medical safety teams, signal detection analyses, and risk mitigation strategies.
- Engage in nonclinical safety risk assessments for due diligence of potential L&A opportunities, as needed.
- Collaborate proactively with CMC functions to assure drug substance quality.
- Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities, as needed.
- Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects.
- Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience.
Benefits
- 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)).
- This position is eligible to participate in the Company’s long-term incentive program.
- 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
