Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Nonclinical Safety
Job Category:Scientific/Technology
All Job Posting Locations:Cambridge, Massachusetts, United States of America, Spring House, Pennsylvania, United States of America
Job Description:Johnson & Johnson Innovative Medicine R&D is recruiting for a Distinguished Scientist, Nonclinical Safety Leader within Preclinical Sciences and Translational Safety (PSTS). This position is a hybrid role and can be located in Spring House, PA or Cambridge, MA.
As a Distinguished Scientist, Nonclinical Safety (NCS) Leader, 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. You will also collaborate with discovery scientists to identify and nominate candidate molecules, and with development teams to bring these molecules to humans and ultimately through global registration.
Principal Responsibilities:
- Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer within the team and interfacing with senior management.
- Serve as NCS representative for global project teams, providing strategic leadership, toxicology expertise, and matrix leadership to ensure high-quality, data-driven decisions that enable efficient progression of portfolio assets from target assessment through commercialization.
- 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 Licensing and Acquisition (L&A) opportunities.
- Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality.
- Actively participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities.
- 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.
- Provide leadership and mentorship within the PSTS organization.
- Lead strategic initiatives as required.
- This role may have future-facing people leadership responsibilities, as needed.
Qualifications:
- A minimum of a Master's degree in Toxicology, Pharmacology or a related discipline is required. Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
- A minimum of 15 years of relevant pharmaceutical/biotech industry experience with a Master's degree or a minimum of 10 years of relevant pharmaceutical/biotech industry experience with a doctoral level degree (PhD, DVM, MD or equivalent) is required.
- Proven experience in representing toxicology/nonclinical safety on multi-disciplinary project teams is required.
- Strong understanding of the drug discovery and development process is required.
- Experience in conducting due diligence activities is preferred.
- Previous experience as a Study Director/Study Monitor under Good Laboratory Practice (GLP) regulations is preferred.
- Familiarity with diverse and emerging/specialized therapeutic modalities is preferred.
- Board certification (e.g. Diplomate of the American Board of Toxicology (DABT)) is preferred.
- Must have excellent oral and written communication skills.
- The ability to collaborate with all levels in a cross-functional team environment is required.
#LI-Hybrid
Required Skills:Preferred Skills:Consulting, Design Mindset, Drug Discovery Development, EHS Compliance, Emergency Planning, Performance Measurement, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Stakeholder Engagement, Strategic Thinking, Technical Writing
The anticipated base pay range for this position is :$164,000.00 - $282,900.00
Additional Description for Pay Transparency:
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
