Full-Time Senior Consultant - Nonclinical Product Development

Nonclinical Product Development supports client programs from research to regulatory submissions. Nonclinical Product Development services include strategic advisory and operational support for toxicology, due diligence, and other products. This role will support client product development, ensuring safety and efficacy. Expertise will shape strategies, optimize timelines, and drive product success.

Responsibilities:

• Develop and evaluate comprehensive nonclinical program strategies.
• Design, review, and refine nonclinical and toxicology study protocols.
• Review SOPs, raw data, and study reports to ensure compliance.
• Identify, evaluate, and select nonclinical vendors.
• Act as Sponsor Study Monitor for non-GLP and GLP studies.
• Provide nonclinical toxicology expertise to stakeholders.
• Support client regulatory submissions.
• Offer strategic guidance for market research, due diligence, and product positioning.
• Assist in business development, including proposal development.
• Provide day-to-day project support.
• Maintain knowledge of nonclinical regulations (FDA, ICH, WHO).
• Adhere to LBG quality standards.
• Support new business initiatives.
• Contribute to internal tools, systems, methods, and resources.
• Travel to client and CRO sites (approx. 3-4 days/month).

Basic Qualifications:

• Advanced degree (MS or PhD) in Pharmacology, Toxicology, or related field.
• Proven experience designing and managing non-GLP and GLP studies.
• Knowledge of Good Laboratory Practices (GLP).
• Familiarity with nonclinical CRO operations.
• Ability to summarize studies and present results to clients.
• Strong organizational skills.
• Proficient computer skills (Microsoft Office 365).
• Dedication to customer satisfaction and scientific integrity.

Preferred Qualifications:

• Experience drafting and compiling nonclinical study information for regulatory submissions.
• Direct experience in specialty toxicology studies (reproductive, carcinogenicity, etc.).
• Experience supporting federally-funded product development programs.

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