Full-Time Senior Consultant - Nonclinical Product Development

The Product Development Group of Sia/LBG provides comprehensive technical support and scientific expertise to advance client programs, guiding them through key product development milestones from early-stage research to regulatory submission and beyond.Sia/LBG Nonclinical Product Development services include strategic advisory and operational support for nonclinical product development, toxicology, and due diligence across a broad range of products, including drugs, biologics, medical devices, and diagnostics. This role will be instrumental in supporting client product development programs, ensuring the safety and efficacy of the products being developed.

This individual’s expertise will play a critical role in shaping research and development strategies, optimizing development timelines, and driving overall product development success. With a deep understanding of nonclinical safety and toxicological assessments, they will assess potential risks and ensure compliance with regulatory standards throughout the development lifecycle.

Additionally, this individual will contribute to various Sia/LBG initiatives, including market research, due diligence, and securing non-dilutive funding for clients through proposal development activities. The ideal candidate should be highly self-motivated, capable of working independently, and possess strong interpersonal skills. Adaptability and the ability to thrive in a fast-paced environment with shifting priorities are essential for success in this role.

Responsibilities:

1. Assist in or oversee the development and evaluation of comprehensive nonclinical program strategies to support product development
2. Design, review, and refine nonclinical and toxicology study protocols to ensure scientific and regulatory rigor
3. Review and assess SOPs, raw data, and both draft and final reports for nonclinical studies to ensure compliance and data integrity
4. Lead the identification, evaluation, and selection of nonclinical vendors, ensuring alignment with study and program requirements
5. Act as a Sponsor Study Monitor for client-sponsored non-GLP and GLP studies, ensuring study integrity and regulatory compliance
6. Provide nonclinical toxicology expertise to internal stakeholders on cross-functional programs
7. Support client regulatory submissions by contributing subject matter expertise, generating, reviewing, and refining nonclinical content as required
8. Offer strategic nonclinical guidance for market research, due diligence, and technical positioning of products in development
9. Assist in business development efforts, including proposal development and capture related to nonclinical services
10. Provide and/or lead day-to-day project support to ensure successful program execution while meeting utilization targets
11. Maintain an up-to-date working knowledge of nonclinical product development regulations (e.g., FDA, ICH, WHO) to ensure compliance and best practices, including a strong understanding of GLP
12. Adhere to LBG quality standards and core values in all client deliverables and engagements
13. Support and, where applicable, lead new business initiatives for both internal and external clients
14. Contribute to the development of internal tools, systems, methods, and resources to enhance efficiency and quality of service delivery at Sia/LBG
15. Travel as needed (approximately 3-4 days per month) to client and CRO sites for study monitoring, audits, and other related activities

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