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Distinguished Scientist – Nonclinical Safety Leader
Johnson & Johnson. Collaborate with scientists across a large portfolio spanning multiple therapeutic areas and innovative modalities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in toxicology and pharmacology with a strong background in drug discovery and development processes. Proven ability to lead cross-functional teams, conduct risk assessments, and communicate effectively with stakeholders and regulatory authorities.
Highest-signal resume keywords
Toxicology LeadershipDrug Discovery and Development ProcessNonclinical Safety AssessmentsGood Laboratory Practice (GLP)Cross-Functional Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ToxicologyPharmacologyRisk AssessmentSafety PharmacologyRegulatory DocumentationSignal DetectionDue DiligenceProject ManagementMolecule DevelopmentPharmacokinetics
Soft Skills
Excellent Communication SkillsLeadershipMentorshipCollaborationProblem-Solving
Certifications & Qualifications
Diplomate of the American Board of Toxicology (DABT)
Industry Keywords
PharmaceuticalBiotechNonclinical SafetyTherapeutic ModalitiesGlobal RegistrationHealth Authority ResponsesChemistry Manufacturing and Controls (CMC)Competitive IntelligenceStakeholder CommunicationStudy Director
About the role
Key responsibilities & impact- Collaborate with scientists across a large portfolio spanning multiple therapeutic areas and innovative modalities
- Provide toxicology leadership for discovery and development projects
- Collaborate with discovery scientists to identify and nominate candidate molecules
- Collaborate with development teams to advance molecules into humans and through global registration
- Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists
- Ensure efficient information transfer within project teams and interface with senior management
- Serve as the NCS representative for global project teams
- Provide strategic leadership, toxicology expertise, and matrix leadership for portfolio decisions
- Create target risk assessments and plans to screen for and mitigate potential risks
- Analyze toxicology and safety pharmacology studies and prepare nonclinical safety assessments
- Contribute to issue-resolution teams through hypotheses and investigative strategies
- Own global regulatory nonclinical documents and health authority responses
- Participate in medical safety teams, signal detection analyses, and risk mitigation strategies
- Conduct nonclinical safety risk assessments for licensing and acquisition due diligence
- Collaborate with Chemistry, Manufacturing and Controls (CMC) functions on drug substance quality
- Participate in external academic or industry societies and consortia
- Maintain scientific knowledge of competitive intelligence and regulatory landscapes
- Communicate with stakeholders and regulatory authorities
- Provide leadership and mentorship within PSTS
- Lead strategic initiatives as required
- Potentially assume future-facing people leadership responsibilities
Requirements
What you’ll need- A minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline is required
- A minimum of 15 years of relevant pharmaceutical/biotech industry experience with a Master’s degree, or a minimum of 10 years with a doctoral level degree, is required
- Proven experience representing toxicology/nonclinical safety on multi-disciplinary project teams
- Strong understanding of the drug discovery and development process
- Excellent oral and written communication skills
- Ability to collaborate with all levels in a cross-functional team environment
- Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline preferred
- Experience in conducting due diligence activities preferred
- Previous experience as a Study Director/Study Monitor under Good Laboratory Practice (GLP) regulations preferred
- Familiarity with diverse and emerging/specialized therapeutic modalities preferred
- Board certification, e.g. Diplomate of the American Board of Toxicology (DABT), preferred
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours
- 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
- Inclusive interview process and workplace accommodations for applicants with disabilities