Principal Scientist, Nonclinical Safety Lead

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, Nonclinical Safety Lead (NCSL) located in Spring House, PA; La Jolla, CA; or Beerse, Belgium.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

As a Principal Scientist, 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 across therapy areas. The NCSL is the single point of accountability within NCS to the Project Team and is the interface between the Project Team and NCS functional and senior management. 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.

Key Responsibilities

The NCSLs' responsibilities include but are not limited to:

• Represent NCS on discovery and development teams, with a high level of autonomy, serving as the single point of contact for a project within NCS and in collaboration with the Therapeutic Area Leader and NCS management.
• Collaborate with multi-disciplinary project teams to design and de-risk discovery phase drug candidates and support clinical development.
• Create target liability assessments and develop fit-for-purpose plans to screen for and manage potential liabilities of novel therapeutics.
• Develop and implement NCS strategic toxicology project plans to inform project advancement decisions, (early) de-risking and safety profiling in discovery and/or development, as well as the NCS project plans (activities, resource requirements, budget and timelines) for the assigned compounds.
• Held responsible for assuring the appropriate prioritization, overall quality, and timely delivery of projects.
• Develop nonclinical safety strategies for novel modalities and/or routes of administration based on an integration of the literature, regulatory guidance, involvement with professional organizations and strong scientific acuity.
• Leads the NCS team, comprising of NCS functional area scientists that support the progression of the assigned compounds.
• Uses drug development experience to effectively communicate across all levels with internal and external partners, including global regulatory authorities.
• Accountable for global regulatory nonclinical documents (e.g. IB, CTA/IND, NDA/MAA/BLA, CTD and responses to regulatory agencies) for assigned projects.
• May present NCS data at meetings with global regulatory authorities.
• May participate with due diligence activities on potential L&A opportunities.

Education

• A Doctoral level degree (PhD, DVM, MD or equivalent) with concentration in toxicology, pharmacology or related discipline and at least 6 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development and demonstrating progressively increasing responsibilities is required

Required:

• Strong in personal leadership skills, pro-active and flexible attitude, strong sense of urgency and scientific curiosity is required.
• Independent thinker, yet also a great teammate is required.
• Excellent oral and written communication skills are required.
• Experience in working in a matrixed and global environment is required.
• Broad understanding of the drug discovery / development process is required.
• The ability to critically evaluate, interpret and integrate large datasets and literature is required.

Preferred:

• Previous experience as a Study Director/Study Monitor conducting/monitoring toxicology studies under Good Laboratory Practice regulations is preferred.
• Experience with different therapeutic modalities such as peptides, bi-specific antibodies, RNA-targeting therapeutics, cell-based therapy, or gene therapy is preferred.
• Experience representing toxicology/nonclinical safety on project teams is preferred.
• Board certification (e.g. DABT) is preferred.

The anticipated base pay range for this position is MIN $131,000 to MAX $225,400.

The anticipated base pay range for this position in San Francisco Bay Area, CA is MIN $150,300 to MAX $259,210.

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.

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)).

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
• Work, Personal and Family Time - up to 40 hours per calendar year

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

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.