Senior Principal Scientist, Developmental and Reproductive Toxicology (DART) at Johnson & Johnson

Spring House, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Expertise in reproductive, developmental, and juvenile toxicology (DART)
Up-to-date knowledge of innovative approaches in predictive/alternative/NAMs DART research
Ability to design DART and juvenile toxicity studies aligned with ICH guidance documents
Capability to oversee and monitor contracted DART and juvenile toxicity studies in compliance with GLPs and animal welfare regulations
Proficiency in integrated scientific data interpretation and critical report review for DART and juvenile toxicity studies
Strong scientific input on mechanisms of developmental/reproductive toxicity in molecular pathways
Expertise demonstrated through publications, presentations, and active engagement in teratology organizations
Ability to work onsite in Spring House, PA, and collaborate with global multi-disciplinary teams across US, Belgium, and China

Responsibilities

Provide subject matter expertise in reproductive, developmental, and juvenile toxicology to global multi-disciplinary teams supporting drug development programs and due diligence activities
Prepare DART target risk assessments and guide DART and juvenile toxicity strategy for biologics, small molecules, and other modalities
Maintain up-to-date knowledge regarding innovative approaches in DART research and possibilities to support DART risk assessment
Prepare DART-related sections for health authority submissions (e.g., marketing authorizations, pediatric plans, briefing books) and responses to questions
Design DART and juvenile toxicity studies for various modalities in alignment with ICH guidance documents
Oversee and monitor contracted DART and juvenile toxicity studies in compliance with Good Laboratory Practices (GLPs) and animal welfare regulations, following company policies and SOPs
Perform integrated scientific data interpretation and critical report review for DART and juvenile toxicity studies
Participate in issue-resolution teams through scientific discussions and shaping strategies for critical development decisions
Provide scientific input on potential mechanisms of developmental/reproductive toxicity and propose follow-up actions
Contribute to PSTS success through participation in internal and external committees/working groups and interaction with scientists in toxicology, pathology, bioanalysis, toxicokinetics, and development project leaders

Skills

DART

Developmental Toxicology

Reproductive Toxicology

Juvenile Toxicity

Nonclinical Safety

Risk Assessment

3Rs Principle

Weight-of-Evidence

Toxicology Strategy

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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