Senior Principal Scientist, Nonclinical Safety Lead at Johnson & Johnson

Spring House, Pennsylvania, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline
Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred
Minimum of 12 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or a minimum of 8 years of experience with a PhD

Responsibilities

Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer within the team
Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management
Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments
Contribute to issue-resolution teams by generating hypotheses and investigative strategies
Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations
Participate in medical safety teams, signal detection analyses, and risk mitigation strategies
Engage in nonclinical safety risk assessments for due diligence of potential L&A opportunities, as needed
Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality
Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities, as needed
Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects
Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience

Skills

Key technologies and capabilities for this role

ToxicologyNonclinical SafetyPreclinical SciencesTranslational SafetyDrug DevelopmentDiscovery Biology

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is a hybrid role located in Spring House, PA.

What is the salary range for this Senior Principal Scientist role?

This information is not specified in the job description.

What are the main responsibilities of the Nonclinical Safety Lead?

The role involves leading PSTS project teams, serving as NCS representative on global teams, creating target risk assessments, analyzing toxicology studies, contributing to issue-resolution, preparing regulatory documents, and participating in medical safety teams.

What is the work environment like at Johnson & Johnson Innovative Medicine?

You will collaborate with innovative and diverse scientists on teams that support projects across multiple therapeutic areas and modalities, championing patients while developing treatments from lab to life.

What makes a strong candidate for this Senior Principal Scientist position?

Strong candidates will have expertise in toxicology leadership across discovery and development, experience providing nonclinical safety assessments for global regulatory submissions, and the ability to collaborate across diverse project teams and therapeutic areas.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free