Scientist Consultant

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.

Benefits

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