Scientist Consultant

Advanced Clinical; Princeton (NJ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group seeks a Nonclinical Scientist Consultant to support preclinical drug discovery through study management, scientific oversight, and regulatory support. You will collaborate with internal teams and external CROs to ensure successful execution, monitoring, and reporting of nonclinical studies.

The ideal candidate has a strong scientific foundation with PK and metabolism study experience and can manage multiple projects in a fast-paced research environment.

Qualifications

• Bachelor's, Master's, or Doctoral degree in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, Toxicology, Pharmacokinetics, or related field.
• For Bachelor's or Master's, 3–5 years of relevant industry experience.
• For PhD candidates, 2 years of relevant industry experience.
• Experience supporting nonclinical drug discovery and development programs.
• Hands-on experience with in vitro/in vivo studies.
• Strong project management, organizational, and prioritization skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple studies and priorities simultaneously.

Responsibilities

• Plan, coordinate, and monitor nonclinical studies at external CROs and lab partners.
• Manage study schedules, timelines, shipments, and operational activities.
• Track study progress and identify risks to timelines and deliverables.
• Coordinate vendor agreements (confidentiality, quality, service, financial).
• Procure and track transfer of study materials and reference standards.
• Maintain study documentation per procedures and regulatory requirements.
• Support audits and assessments of external labs and vendors.
• Review study protocols, data packages, and final reports for quality and accuracy.
• Provide scientific input on study design and experimental approaches.
• Interpret and communicate study findings to project teams.

Skills

Project management

Scientific writing

Stakeholder management

Communication

Education

Bachelor's/Master's/Doctoral in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, Toxicology, Pharmacokinetics

Job description

We are seeking a Nonclinical Scientist Consultant to support preclinical drug discovery and development programs through study management, scientific oversight, vendor coordination, and regulatory support activities. This role will collaborate with internal stakeholders and external research organizations to ensure the successful execution, monitoring, and reporting of nonclinical studies.

The ideal candidate will bring a strong scientific foundation, experience supporting pharmacokinetic and drug metabolism studies, and the ability to effectively manage multiple projects in a fast-paced research environment.

Key Responsibilities

Study Management & Vendor Oversight

• Support the planning, coordination, and monitoring of nonclinical studies conducted at external contract research organizations (CROs) and laboratory partners.
• Manage study schedules, timelines, study material shipments, and associated operational activities.
• Track study progress and proactively identify risks to project timelines and deliverables.
• Coordinate implementation and maintenance of vendor agreements, including confidentiality, quality, service, and financial agreements.
• Procure, track, and manage the transfer of study materials and reference standards to external laboratories.
• Maintain study documentation and archival records in accordance with internal procedures and regulatory requirements.
• Support audits and assessments of external research organizations and laboratory vendors.

Scientific Support

• Review study protocols, data packages, and final reports for scientific quality, accuracy, and completeness.
• Evaluate study execution, data collection, analysis methods, and overall study conduct.
• Provide scientific input on study design and experimental approaches.
• Interpret and communicate study findings to project teams and stakeholders.
• Support the generation and review of scientific and technical documentation related to nonclinical development programs.
• Contribute to cross-functional discussions regarding study outcomes and development strategies.

Quality & Regulatory Support

• Prepare, review, and maintain quality control documentation, including protocols, reports, test methods, and supporting technical records.
• Perform quality control reviews of regulatory submission documents and supporting study reports.
• Ensure study documentation meets applicable quality standards and regulatory expectations.
• Assist with inspection readiness and documentation compliance activities.
• Support process improvement initiatives related to study management, data review, and documentation practices.

Required Qualifications

• Bachelor's, Master's, or Doctoral degree in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, Toxicology, Pharmacokinetics, or a related scientific discipline.
• For Bachelor's or Master's degree candidates, a minimum of 3-5 years of relevant industry experience is required.
• For PhD candidates, a minimum of 2 years of relevant industry experience is required.
• Experience supporting nonclinical drug discovery and development programs within the pharmaceutical, biotechnology, contract research, or related life sciences industries.
• Hands-on experience supporting in vitro and/or in vivo studies.
• Strong project management, organizational, and prioritization skills.
• Excellent written and verbal communication skills.
• Ability to effectively manage multiple studies and competing priorities simultaneously.

Preferred Qualifications

• Experience supporting Drug Metabolism and Pharmacokinetics (DMPK) programs.
• Knowledge of pharmacokinetics, metabolism, drug-drug interaction assessment, or related disciplines.
• Experience outsourcing and managing studies through CROs or external laboratory partners.
• Familiarity with regulatory submission documentation and quality review processes.
• Experience supporting multidisciplinary research and development teams.
• Previous involvement in regulatory submissions or study support activities across various stages of development.

Key Competencies

• Strong scientific and analytical thinking.
• Attention to detail and commitment to data quality.
• Effective stakeholder and vendor management skills.
• Ability to interpret complex scientific data and communicate findings clearly.
• Proactive problem-solving and risk-management abilities.
• Strong organizational skills with the ability to manage multiple timelines and deliverables.
• Collaborative approach to cross-functional teamwork.

Position Overview

We are seeking a Nonclinical Scientist Consultant to support preclinical drug discovery and development programs through study management, scientific oversight, vendor coordination, and regulatory support activities. This role will collaborate with internal stakeholders and external research organizations to ensure the successful execution, monitoring, and reporting of nonclinical studies.

The ideal candidate will bring a strong scientific foundation, experience supporting pharmacokinetic and drug metabolism studies, and the ability to effectively manage multiple projects in a fast-paced research environment.

Key Responsibilities

Study Management & Vendor Oversight

• Support the planning, coordination, and monitoring of nonclinical studies conducted at external contract research organizations (CROs) and laboratory partners.
• Manage study schedules, timelines, study material shipments, and associated operational activities.
• Track study progress and proactively identify risks to project timelines and deliverables.
• Coordinate implementation and maintenance of vendor agreements, including confidentiality, quality, service, and financial agreements.
• Procure, track, and manage the transfer of study materials and reference standards to external laboratories.
• Maintain study documentation and archival records in accordance with internal procedures and regulatory requirements.
• Support audits and assessments of external research organizations and laboratory vendors.

Scientific Support

• Review study protocols, data packages, and final reports for scientific quality, accuracy, and completeness.
• Evaluate study execution, data collection, analysis methods, and overall study conduct.
• Provide scientific input on study design and experimental approaches.
• Interpret and communicate study findings to project teams and stakeholders.
• Support the generation and review of scientific and technical documentation related to nonclinical development programs.
• Contribute to cross-functional discussions regarding study outcomes and development strategies.

Quality & Regulatory Support

• Prepare, review, and maintain quality control documentation, including protocols, reports, test methods, and supporting technical records.
• Perform quality control reviews of regulatory submission documents and supporting study reports.
• Ensure study documentation meets applicable quality standards and regulatory expectations.
• Assist with inspection readiness and documentation compliance activities.
• Support process improvement initiatives related to study management, data review, and documentation practices.

Required Qualifications

• Bachelor's, Master's, or Doctoral degree in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, Toxicology, Pharmacokinetics, or a related scientific discipline.
• For Bachelor's or Master's degree candidates, a minimum of 3-5 years of relevant industry experience is required.
• For PhD candidates, a minimum of 2 years of relevant industry experience is required.
• Experience supporting nonclinical drug discovery and development programs within the pharmaceutical, biotechnology, contract research, or related life sciences industries.
• Hands-on experience supporting in vitro and/or in vivo studies.
• Strong project management, organizational, and prioritization skills.
• Excellent written and verbal communication skills.
• Ability to effectively manage multiple studies and competing priorities simultaneously.

Preferred Qualifications

• Experience supporting Drug Metabolism and Pharmacokinetics (DMPK) programs.
• Knowledge of pharmacokinetics, metabolism, drug-drug interaction assessment, or related disciplines.
• Experience outsourcing and managing studies through CROs or external laboratory partners.
• Familiarity with regulatory submission documentation and quality review processes.
• Experience supporting multidisciplinary research and development teams.
• Previous involvement in regulatory submissions or study support activities across various stages of development.

Key Competencies

• Strong scientific and analytical thinking.
• Attention to detail and commitment to data quality.
• Effective stakeholder and vendor management skills.
• Ability to interpret complex scientific data and communicate findings clearly.
• Proactive problem-solving and risk-management abilities.
• Strong organizational skills with the ability to manage multiple timelines and deliverables.
• Collaborative approach to cross-functional teamwork.

#MSPTalent

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].