Staff Preclinical Scientist

Johnson & Johnson • West Chester, PA

2d • Hybrid

About The Position

The Staff Preclinical Scientist functions as a key member of the DS Toxicology, Biocompatibility and Preclinical team. This person designs, conducts, and interprets preclinical in vivo studies that provide evidence of device safety, performance, and translational relevance while ensuring ethical animal use and regulatory compliance. In addition, the person will apply technical expertise, ingenuity, business experience, and independent judgment to solve preclinical and biological functional safety and performance problems, and designs and implement strategies and priorities for evaluations and studies across multiple projects or product portfolios.

Requirements

• A 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 applicable regulatory requirements and guidance for non-clinical studies.
• Experience authoring scientific protocols, study reports, technical assessments, and regulatory documentation.

Nice To Haves

• Experience in orthopedic, spine, trauma, sports medicine, or other medical device therapeutic areas.

Responsibilities

• Develops preclinical testing strategies to support product development, regulatory submissions, and clinical translation.
• Designs in vivo studies that evaluate device safety, functionality, performance, and clinical relevance.
• Selects appropriate animal models, study endpoints, controls, and evaluation methods based on intended use and regulatory expectations.
• Ensures study objectives address key product risks, design questions, and performance claims.
• Acts as study sponsor representative for external CRO and research site activities.
• Prepares study protocols, technical justifications, and study documentation.
• Oversees study conduct to ensure compliance with applicable regulations, GLP requirements, and animal welfare standards.
• Analyzes and interprets study data.
• Identifies potential risks, failure modes, and opportunities for design improvement.
• Stays current with evolving regulatory guidance and drives continuous improvement in preclinical methodologies and study designs.
• Partners with R&D, Clinical, Regulatory Affairs, Biocompatibility, Toxicology, Quality, and Marketing teams.
• Provides consultative direction as well as technical guidance to meet essential requirements necessary to achieve a high-quality product.
• Supports interactions with regulatory authorities by providing scientific rationale and study interpretations.
• Manages prioritization and communicates resource needs and updates in project support to the PMO and Manager.
• Identifies and evaluates potential risks and drives proactive resolution with team members, peers, PMO and management.
• May oversee and lead the work of a group of people and supervise direct reports/contractors.
• Provides guidance and mentorship to junior scientists on the team.
• Can represent the company in regulatory meetings, conferences, standards committees, or industry consortia.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior