Senior Consultant - Nonclinical Product Development - Sia/LBG

Company Description

About Sia 

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. 

Why Join Sia? 

Excellence | Entrepreneurship | Innovation | Teamwork | Care & Support | Employee Wellbeing  

These are the six core values that guide all our actions.   

Your experience at Sia will be enriched by a(n):    

• Entrepreneurial journey  
• Support with achieving professional development goals through guidance and real-time feedback  
• Continuous learning & development opportunities  

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.

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:

Technical & Scientific:

• Assist in or oversee the development and evaluation of comprehensive nonclinical program strategies to support product development
• Design, review, and refine nonclinical and toxicology study protocols to ensure scientific and regulatory rigor
• Review and assess standard operating procedures (SOPs), raw data, and both draft and final reports for nonclinical studies to ensure compliance and data integrity
• Lead the identification, evaluation, and selection of nonclinical vendors, ensuring alignment with study and program requirements
• Act as a Sponsor Study Monitor for client-sponsored non-GLP and GLP studies, ensuring study integrity and regulatory compliance
• Provide nonclinical toxicology expertise to internal stakeholders on cross-functional programs
• Support client regulatory submissions by contributing subject matter expertise, generating, reviewing, and refining nonclinical content as required
• Offer strategic nonclinical guidance for market research, due diligence, and technical positioning of products in development
• Assist in business development efforts, including proposal development and capture related to nonclinical services
• Provide and/or lead day-to-day project support to ensure successful program execution while meeting utilization targets
• 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 Good Laboratory Practices (GLP)
• Adhere to LBG quality standards and core values in all client deliverables and engagements
• Support and, where applicable, lead new business initiatives for both internal and external clients
• Contribute to the development of internal tools, systems, methods, and resources to enhance efficiency and quality of service delivery at Sia/LBG
• Travel as needed (approximately 3-4 days per month) to client and CRO sites for study monitoring, audits, and other related activities

Qualifications

Basic Qualifications:

• Advanced degree (M.S. or PhD) in a Pharmacology, Toxicology, or other related life science discipline with appropriate years of experience:
  • Ph.D. with 3 years of experience, including a minimum of 2 years as a Study Director (general toxicology/PK) in the nonclinical CRO industry
  • M.S. with 5 years of experience, including a minimum of 4 years as a Study Director (general toxicology/PK) in the nonclinical CRO industry
• Proven experience in designing and managing non-GLP and GLP studies through cross-functional teams, including but not limited to:
  • Development, generation, and review of study protocols and reports
  • Creation of documentation (paper/electronic) in compliance with all applicable regulations
  • Oversight of general study procedures, ensuring adherence to FDA regulations, site-specific protocols, and animal welfare policies
• Comprehensive knowledge of Good Laboratory Practices (GLP) (21 CFR Part 58).
• Familiarity with nonclinical CRO operations, including:
  • The CRO identification, selection and contracting process
  • Study setup, initiation, and closeout procedures
  • The auditing process
• Demonstrated ability to effectively summarize nonclinical studies in written format and ability to evaluate and communicate or present results of nonclinical studies to clients
• General knowledge of current nonclinical guidance from applicable regulatory bodies (i.e., FDA, ICH, WHO, etc.) as they pertain to nonclinical product development
• Ability to lead and support teams of a cross-functional and multi-level nature independently and/or in a group setting in a virtual format
• Strong organizational skills and ability to prioritize and manage technical and administrative aspects of multiple projects simultaneously
• Proficient computer skills and ability to learn new software and systems with direct experience with Microsoft Office 365
• Demonstrated dedication to customer satisfaction and maintenance of scientific integrity
• Flexible in adjusting priorities and able to take risks to accomplish goals
• Effectiveness and creativity in approaching and solving technical problems

Preferred Qualifications:

• Experience drafting and compiling nonclinical study information for regulatory submissions (e.g. Pre-IND, IND, etc.)
• Direct experience designing and conducting specialty toxicology studies (i.e., reproductive toxicology, carcinogenicity, immunotoxicology, etc.) in accordance with applicable guidelines
• Experience supporting federally-funded (DOD and/or HHS) product development programs
• Working knowledge of animal health / veterinary product development

Additional Information

Compensation & Benefits 

• Salary Annual Discretionary Bonus 
• Healthcare coverage that includes 3 medical plan options: Anthem – EPO HSA, EPO HSA MERP, and PPO; dental and vision through MetLife; and life insurance policies through Mutual of Omaha 
• Flexible Spending Account (FSA) 
• Paid Time Off  
• Parental leave paid at 100% of base pay for all new parents   
• 9 Company Holidays 1 Floating Holiday  
• 401(k) Plan - 4% matching and vested on day 1  
• College save-up plan & college loan repayment plan 
• Monthly cell phone stipend  
• Pre-tax account for Parking and Mass Transit  
• Sia provides several wellness and incentive programs free of charge through the firm medical plan – Anthem - such as:  
  • Gym Reimbursement 
  • LiveHealth Online 
  • Well-being Coach 
  • Building Healthy Families Program  
  • And much more 

Diversity, Equity, Inclusion & Belonging 

At Sia, we believe in fostering a diverse, equitable and inclusive culture where our employees and partners are valued and thrive in a sense of belonging. We are committed to recruiting and developing a diverse network of employees and investing in their growth by providing unique opportunities for professional and cultural immersion. Our commitment toward inclusion motivates dynamic collaboration with our clients, building trust by creating an inclusive environment of curiosity and learning which affects lasting impact. Please visit our website for more information.  

Office Workplace Guidelines 

Sia is committed to providing a flexible workplace environment that supports client, business, and market needs. Consultants located in our primary market office locations—New York City, Charlotte, Seattle, and San Francisco—are expected to live within a reasonable commuting distance and attend the office at least three days per week. For Consultants outside of our primary markets, we can offer more flexible in-person requirements in accordance with your location. 

Work Authorization & Sponsorship  

At this time, Sia does not intend to pursue employment with applicants who will require now or in the future visa by our company for work authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa, or any other non-immigrant status).

Sia is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.