Distinguished Scientist – Nonclinical Safety Leader

Johnson & Johnson

. Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists .

Posted 10/6/2026full-timeUnited StatesSenior💰 $164,000 - $282,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in toxicology and pharmacokinetics, with a strong background in leading nonclinical safety projects and collaborating across multidisciplinary teams. Proven ability to manage regulatory documents and communicate effectively with stakeholders and health authorities.

Highest-signal resume keywords

Toxicology ExpertisePharmacokinetics KnowledgeRegulatory Document ManagementCross-Functional CollaborationLeadership and Mentorship

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Nonclinical Safety AssessmentsRisk Assessment CreationDrug Discovery Process UnderstandingSignal Detection AnalysisDue Diligence ActivitiesGood Laboratory Practice (GLP)Toxicology Study DirectionPharmacology AnalysisCandidate Molecule NominationPortfolio Project Management

Soft Skills

Excellent Communication SkillsStrategic LeadershipMentorship AbilitiesCollaboration SkillsProblem-Solving

Certifications & Qualifications

Diplomate of the American Board of Toxicology (DABT)

Industry Keywords

Pharmaceutical IndustryBiotech IndustryNonclinical SafetyHealth Authority InteractionTherapeutic ModalitiesProject Team LeadershipMatrix LeadershipCompetitive IntelligenceRegulatory LandscapesCross-Functional Teams

About the role

Key responsibilities & impact

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 NCS representative for global project teams
Provide strategic leadership, toxicology expertise, and matrix leadership for portfolio projects
Support progression of portfolio assets from target assessment through commercialization
Collaborate with discovery scientists to identify and nominate candidate molecules
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 hypotheses and investigative strategies to issue-resolution teams
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 opportunities
Collaborate with CMC functions to assure drug substance quality
Participate in external academic or industry societies and consortia
Maintain scientific depth and knowledge of competitive intelligence and regulatory landscapes
Communicate with stakeholders and regulatory authorities
Provide leadership and mentorship within the PSTS organization
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 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, such as 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; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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
Hybrid work arrangement
Inclusive interview process and accommodations for applicants with disabilities