Staff Preclinical Scientist

OneTrust

Staff Preclinical Scientist designing and interpreting in vivo studies for Johnson & Johnson MedTech devices. Supporting safety, regulatory submissions, clinical translation, and cross-functional product development.

Posted 8/10/2026full-timeWest Chester • Massachusetts, Pennsylvania • 🇺🇸 United StatesLead💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing preclinical testing strategies, designing in vivo studies, and ensuring compliance with regulatory requirements. Proficient in analyzing preclinical data and providing consultative direction to support product development across multidisciplinary teams.

Highest-signal resume keywords

In Vivo Study DesignRegulatory CompliancePreclinical Data AnalysisScientific Protocol AuthoringAnimal Research Methodologies

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Preclinical Testing StrategiesStudy Protocol PreparationTechnical AssessmentData InterpretationRisk IdentificationStudy Endpoint SelectionAnimal Model SelectionRegulatory DocumentationGLP ComplianceStudy Conduct Oversight

Soft Skills

MentoringCommunicationConsultative DirectionTeam CollaborationProject Management

Industry Keywords

Medical DevicePharmaceuticalCROToxicologyBiocompatibilityClinical TranslationHealth and Safety ComplianceOrthopedicTraumaSports Medicine

About the role

Key responsibilities & impact

Develop preclinical testing strategies supporting product development, regulatory submissions, and clinical translation
Design in vivo studies evaluating device safety, functionality, performance, and clinical relevance
Select animal models, study endpoints, controls, and evaluation methods based on intended use and regulatory expectations
Ensure study objectives address product risks, design questions, and performance claims
Act as study sponsor representative for external CRO and research site activities
Prepare study protocols, technical justifications, study reports, technical assessments, and regulatory documentation
Oversee study conduct for regulatory, GLP, and animal welfare compliance
Analyze and interpret preclinical data and study reports
Identify risks, failure modes, and design improvement opportunities
Monitor regulatory guidance and drive continuous improvement in preclinical methodologies and study designs
Partner with R&D, Clinical, Regulatory Affairs, Biocompatibility, Toxicology, Quality, and Marketing teams across multiple projects
Provide consultative direction and technical guidance to support high-quality product development
Support regulatory authority interactions with scientific rationale and study interpretations
Manage prioritization and communicate resource needs and project updates to the PMO and Manager
Drive proactive risk resolution with team members, peers, PMO, and management
May lead groups and supervise direct reports or contractors
Mentor junior scientists
Represent the company in regulatory meetings, conferences, standards committees, or industry consortia
Communicate business-related issues or opportunities to the next management level
Follow and ensure compliance with applicable Health, Safety and Environmental practices, regulations, policies, and procedures

Requirements

What you’ll need

Bachelor’s or Master’s degree or PhD in biology, chemistry, toxicology, microbiology, veterinary medicine, or a related scientific discipline
Training in animal research methodologies, pathology, or histopathology
5–8 years of experience in medical device, pharmaceutical, CRO, or academic research environments
Experience designing, executing, and interpreting in vivo studies
Experience working with external research organizations (CROs) and study sites
Experience analyzing and interpreting preclinical data and study reports
Working knowledge of regulatory requirements and guidance for non-clinical studies
Experience authoring scientific protocols, study reports, technical assessments, and regulatory documentation
Preferred: experience in orthopedic, spine, trauma, sports medicine, or other medical device therapeutic areas

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 per calendar year for employees who reside in Colorado; 56 hours per calendar year for employees who reside 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
Inclusive interview process and accommodation support for applicants with disabilities
Hybrid work arrangement