Full-Time Senior Consultant - Nonclinical Product Development

Product Development: Sia/LBG provides technical support and scientific expertise to advance client programs through key product development milestones. This role supports product development programs, ensuring safety and efficacy. Expertise shapes research & development strategies, optimizes timelines, and drives success.

Responsibilities:

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

Qualifications:

• Advanced degree (MS or PhD) in pharmacology, toxicology, or related life science.
• Proven experience in designing and managing non-GLP and GLP studies.
• Knowledge of Good Laboratory Practices (GLP).
• Familiarity with nonclinical CRO operations.
• Ability to effectively summarize nonclinical studies.
• Strong organizational skills and ability to manage multiple projects.
• Proficient computer skills (Microsoft Office 365).
• Dedication to customer satisfaction and scientific integrity.
• Adaptability and ability to work in a fast-paced environment.

Preferred Qualifications:

• Experience drafting regulatory submissions (e.g., Pre-IND, IND).
• Direct experience with specialty toxicology studies.
• Experience supporting federally-funded programs.

Compensation & Benefits:

• Salary range: $105,000 - $150,000

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