Job description

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.

As a Principal Consultant within the Nonclinical Product Development Sector, you will serve as a senior subject matter expert, providing both strategic advisory and hands-on operational support for nonclinical product development, toxicology, and regulatory strategy across a diverse portfolio of therapeutic modalities, including small molecules, monoclonal antibodies, vaccines, biologics, and cell and gene therapies. This role requires a unique combination of deep technical expertise and strategic thinking to lead complex nonclinical programs from concept through regulatory approval.

In this senior leadership position, you will be instrumental in shaping nonclinical development strategies for client programs across pharmaceutical, biotechnology, and advanced therapy products. Your expertise will be critical in designing comprehensive nonclinical programs, assessing safety and efficacy profiles, identifying and mitigating potential risks, optimizing development timelines, and ensuring regulatory compliance throughout the product development lifecycle. You will serve as a trusted advisor to clients, providing strategic guidance on complex scientific and regulatory challenges while also delivering hands-on operational support, including study design, vendor selection and management, study monitoring, and preparation of regulatory submissions.

Beyond direct client engagement, you will play a key role in business development activities, including proposal development, technical due diligence assessments, market research, and support for securing non-dilutive funding opportunities from federal agencies. The ideal candidate is a highly accomplished nonclinical development professional with 10-15+ years of progressive industry experience, combining deep scientific expertise with proven leadership capabilities. You must be self-motivated, capable of managing multiple complex projects independently, and possess exceptional interpersonal and communication skills to effectively engage with clients, regulatory agencies, and cross-functional teams. Success in this role requires adaptability, strategic thinking, and the ability to thrive in a dynamic, fast-paced consulting environment with evolving priorities and diverse client needs.

Responsibilities:

Technical & Scientific:

• Lead the development and evaluation of comprehensive nonclinical program strategies to support product development across small molecules, monoclonal antibodies, vaccines, biologics, and cell and gene therapies.
• Provide strategic nonclinical guidance and subject matter expertise to clients throughout the product development lifecycle, from preclinical research through regulatory submission and commercialization.
• Design, review, and refine nonclinical and toxicology study protocols across multiple modalities, ensuring scientific rigor, regulatory compliance, and alignment with product-specific requirements.
• Serve as a strategic advisor for complex nonclinical development challenges, including novel therapeutic modalities and emerging technologies in the cell and gene therapy space.
• Review and assess standard operating procedures (SOPs), raw data, and both draft and final reports for nonclinical studies to ensure compliance, data integrity, and scientific quality.
• Lead the identification, evaluation, and selection of nonclinical vendors and CROs, ensuring alignment with study requirements and expertise in relevant therapeutic modalities.
• Provide nonclinical toxicology, pharmacokinetic, and/or pharmacology expertise to internal and external stakeholders on cross-functional, multi-disciplinary programs.
• Lead and contribute, as needed, to client regulatory submissions by providing subject matter expertise, generating, reviewing, and refining nonclinical content.
• Offer strategic nonclinical guidance for market research, due diligence assessments, competitive intelligence, and technical positioning of products in development.
• Assit in or lead business development efforts, including proposal development, technical writing, and client presentations related to nonclinical services across diverse therapeutic areas.
• Provide strategic and operational leadership for day-to-day project execution, mentoring junior staff, and ensuring successful program delivery while meeting utilization targets.
• Maintain current expertise in nonclinical product development regulations and guidance documents (e.g., FDA, EMA, ICH, WHO) across all relevant product types, including emerging regulatory frameworks for advanced therapies.
• Serve as a thought leader in nonclinical development, staying abreast of scientific advances, regulatory trends, and industry best practices across small molecules, biologics, and advanced therapy medicinal products (ATMPs).
• Adhere to Sia LBG quality standards and core values in all client deliverables and engagements, ensuring the highest level of scientific integrity and client satisfaction.
• Lead and support new business initiatives for both internal and external clients, identifying opportunities for service expansion and strategic partnerships.
• Contribute to the development of internal tools, training programs, standard operating procedures, and resources to enhance efficiency, quality, and technical capabilities at Sia LBG.
• Travel as needed to client sites for audits, strategic meetings, and related activities.