[China Position] Sr. Principal Scientist, Toxicology

Scorpion Therapeutics; New Jersey; On-site; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics in New Jersey seeks a senior toxicology leader to guide nonclinical safety programs for CAR-T and other cell/gene therapy.

You will design GLP studies, integrate toxicology with pharmacology data, and provide risk assessments and development recommendations across programs.

The role requires a PhD/MD/Vet with 8+ years in nonclinical toxicology, CRO oversight, and knowledge of US FDA/ICH regulatory expectations.

Qualifications

• PhD/MD/DVM or equivalent in toxicology or related field.
• 8+ years in nonclinical toxicology within biotech/pharma R&D.
• GLP toxicology and nonclinical pharmacology study knowledge; CRO management and regulatory expectations.
• Experience with IND-enabling packages and global regulatory submissions.
• Knowledge of FDA/EMA/ICH regulations for toxicology and cell/gene therapy.
• Experience evaluating immune-mediated toxicities, biodistribution, PK, and safety considerations.
• Strong scientific writing, communication, presentation, leadership, mentoring, and project management skills.
• Ability to work independently in a matrixed environment.

Responsibilities

• Lead toxicology activities for in vivo CAR-T and other cell and gene therapy programs.
• Design, monitor, interpret, and report nonclinical safety, biodistribution, pharmacokinetic, immune toxicity, and related safety studies.
• Integrate toxicology and pharmacology data to support candidate selection, risk assessment, and program progression.
• Interpret mouse and NHP preclinical data and provide risk assessments and development recommendations.
• Provide sponsor oversight for toxicology studies (planning, CRO management, protocol/report review, monitoring, data interpretation).
• Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
• Contribute to safety risk assessments (target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis).
• Support regulatory document preparation/submissions (INDs, health authority responses).
• Interpret complex nonclinical datasets and communicate findings/recommendations.
• Provide toxicology technical leadership for strategy, project initiation, and nonclinical development planning.
• Mentor junior scientists; support growth of toxicology capabilities.
• Support in vivo pharmacology activities as needed via integrated efficacy/disposition/safety assessment.

Skills

Scientific writing

Communication

Leadership

Mentoring

Project management

Independent work

Education

PhD or equivalent in Toxicology/Pharmacology/Immunology

Job description

Role Responsibilities:

• Lead toxicology activities for in vivo CAR-T and other cell and gene therapy programs.
• Design, monitor, interpret, and report nonclinical safety, biodistribution, pharmacokinetic, immune toxicity, and related safety studies.
• Integrate toxicology and pharmacology data to support candidate selection, risk assessment, and program progression.
• Interpret mouse and NHP preclinical data and provide risk assessments and development recommendations.
• Provide sponsor oversight for toxicology studies (study planning, CRO management, protocol/report review, monitoring, data interpretation, issue resolution).
• Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
• Contribute to safety risk assessments (target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis, long-term safety).
• Support regulatory document preparation/submissions (China IIT, IND applications, investigator brochures, global filings, responses to health authority questions).
• Interpret complex nonclinical datasets and communicate findings/recommendations.
• Provide toxicology technical leadership for strategy, project initiation, and nonclinical development planning.
• Mentor junior scientists; support growth of toxicology capabilities.
• Support in vivo pharmacology activities as needed via integrated efficacy/disposition/safety assessment.

Qualifications:

• Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology, or related field.
• 8+ years in nonclinical toxicology (or related) in biotech/pharma R&D; knowledge of pharmacology principles.
• GLP toxicology and nonclinical pharmacology study knowledge; CRO management and regulatory expectations.
• Experience with IND-enabling packages and global regulatory submissions (highly desirable).
• Knowledge of NMPA, FDA, EMA, and ICH regulations for toxicology and cell/gene therapy.
• Experience evaluating immune-mediated toxicities, biodistribution, pharmacokinetics, insertional mutagenesis, and other safety considerations.
• Scientific writing, communication, presentation, leadership, mentoring, and project management skills.
• Ability to work independently in a collaborative, matrixed environment.