Senior Consultant - Nonclinical Product Development - SiaLBG

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 earlystage 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 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 individuals 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 nondilutive funding for clients through proposal development activities. The ideal candidate should be highly selfmotivated capable of working independently and possess strong interpersonal skills. Adaptability and the ability to thrive in a fastpaced 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 clientsponsored nonGLP and GLP studies ensuring study integrity and regulatory compliance
• Provide nonclinical toxicology expertise to internal stakeholders on crossfunctional 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 daytoday project support to ensure successful program while meeting utilization targets
• Maintain an uptodate 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 34 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 nonGLP and GLP studies through crossfunctional 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 sitespecific 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 crossfunctional and multilevel 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. PreIND IND etc.
• Direct experience designing and conducting specialty toxicology studies (i.e. reproductive toxicology carcinogenicity immunotoxicology etc. in accordance with applicable guidelines
• Experience supporting federallyfunded (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 saveup plan & college loan repayment plan 
• Monthly cell phone stipend 
• Pretax 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 
  • Wellbeing 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 locationsNew York City Charlotte Seattle and San Franciscoare 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 inperson 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. H1B visa F1 visa (OPT) TN visa or any other nonimmigrant 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.