Principal Consultant - Nonclinical Product Development

Company Description

Sia is a next-generation, global management consulting group. Founded in 1999, we were born digital. Today our strategy and management capabilities are augmented by data science, enhanced by creativity and driven by responsibility. We’re optimists for change and we help clients initiate, navigate and benefit from transformation. We believe optimism is a force multiplier, helping clients to mitigate downside and maximize opportunity. With expertise across a broad range of sectors and services, our 3,000 consultants serve clients worldwide from 48 locations in 19 countries. Our expertise delivers results. Our optimism transforms outcomes. 

Sia’s Life Science and Healthcare Business Unit, Sia/LBG, focuses on supporting the life sciences and healthcare industries with strategic consulting, product development and non-dilutive funding expertise. This consulting division works with healthcare organizations, pharmaceutical & biotech companies, CROs, academia, medical device/diagnostic companies, and non-governmental organizations (NGOs) alike to solve complex business, scientific, regulatory, technological and product development challenges.  Our subject matter experts help advance our clients products and programs; supporting these companies—both large and small—to achieve organizational objectives and create tangible value for their stakeholders.

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 non