Principal 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.

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.

Qualifications :

Basic Qualifications:

• Advanced degree (M.S. or Ph.D.) in Pharmacology Pharmacokinetics Toxicology or a related life sciences discipline (e.g. Biochemistry Biology Physiology) with commensurate professional experience:
  • Ph.D. with a minimum of 10 years of progressive industry experience including at least 4 years serving as a Study Director for general toxicology and/or pharmacokinetic studies within a nonclinical CRO environment or 4 years providing direct nonclinical programmatic oversight for pharmaceutical or biotechnology product development.
  • M.S. with a minimum of 15 years of progressive industry experience including at least 6 years serving as a Study Director for general toxicology and/or pharmacokinetic studies within a nonclinical CRO environment or 6 years providing direct nonclinical programmatic oversight for pharmaceutical or biotechnology product development.
• Minimum of 5 years of direct hands-on experience in pharmacokinetic modeling and analysis including demonstrated proficiency with applicable regulatory guidelines industry-standard software platforms and best practices.
• Demonstrated expertise in designing executing and managing nonclinical studies through cross-functional teams with specific experience in:
  • Development generation critical review and approval of study protocols and final reports.
  • Creation and management of compliant documentation (paper and electronic) in accordance with all applicable regulatory requirements.
  • Oversight of study operations and procedures ensuring adherence to FDA regulations ICH guidelines site-specific protocols and animal welfare standards.
• Direct experience supporting federally funded product development programs (e.g. DOD BARDA NIH) in the capacity of either a subcontractor or principal investigator/funded developer.
• Comprehensive knowledge and practical application of Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and related quality systems.
• Extensive familiarity with nonclinical CRO operations and business processes including:
  • CRO evaluation selection and contracting processes.
  • Study planning initiation execution and closeout procedures.
  • Quality assurance and auditing processes.
• Proven ability to synthesize complex nonclinical data and effectively communicate study designs results and strategic recommendations in written and oral formats to diverse audiences including clients regulatory agencies and internal stakeholders.
• Thorough knowledge of current nonclinical regulatory guidance documents from relevant regulatory authorities (e.g. FDA EMA ICH WHO) as they pertain to pharmaceutical biologic and advanced therapy product development.
• Demonstrated leadership capability in managing and collaborating with cross-functional multi-level teams in both independent and collaborative settings with proficiency in virtual work environments.
• Exceptional organizational skills with demonstrated ability to prioritize competing demands and manage the technical and administrative aspects of multiple concurrent projects effectively.
• Advanced proficiency with computer systems and software applications including Microsoft Office 365 suite with demonstrated ability to rapidly learn and adapt to new technologies and platforms.
• Unwavering commitment to customer satisfaction scientific integrity and ethical conduct in all professional activities.
• Flexibility and adaptability in adjusting priorities in dynamic environments with a demonstrated willingness to take calculated risks to achieve strategic objectives.
• Creative and effective problem-solving skills with a track record of developing innovative solutions to complex technical and operational challenges.

Preferred Qualifications:

• Demonstrated expertise in bioanalytical method development qualification and/or validation including comprehensive understanding of applicable regulatory guidelines and proven ability to critically evaluate and interpret bioanalytical reports
• Extensive experience in the design execution and interpretation of specialty toxicology studies including but not limited to reproductive and developmental toxicology carcinogenicity assessments immunotoxicology genetic toxicology and phototoxicity studies conducted in accordance with relevant ICH and regulatory guidelines
• Proven track record in authoring compiling and reviewing nonclinical sections of regulatory submissions including Pre-IND briefing documents Investigational New Drug (IND) applications Biologics License Applications (BLAs) New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs).
• Advanced knowledge of nonclinical development strategies specific to complex modalities including monoclonal antibodies antibody-drug conjugates (ADCs) bispecific antibodies vaccines cell therapies gene therapies and other advanced therapy medicinal products (ATMPs).
• Familiarity with comparative medicine translational science principles and the application of pharmacokinetic/pharmacodynamic (PK/PD) modeling to support dose selection and clinical trial design.

Additional Information :

Compensation & Benefits 

We believe in supporting our team professionally and personally. Heres a snapshot of the comprehensive benefits youll enjoy as part of Sia. 

Competitive Compensation 

• Annual base salary starting at $168300-$21900 (commensurate with experience and qualifications)
• Annual performance based discretionary bonus 

Robust Health Coverage 

• 3 Medical plans  

• Dental and Vision  

• Life AD&D and other voluntary insurance  

Tax-Advantaged Accounts 

• 401K retirement plan 

• 4% matching and 100% vested upon enrollment 

• Health Savings Account (HSA) 

• Flexible Spending Account (FSA)  

• Health Dependent Care Commuter 

Family Friendly Benefits  

• 100% paid parental leave for all new parents with eligible tenure 

• Building Healthy Families program if enrolled through Medical plan 

Time Off to Recharge 

• Generous Paid Time Off (PTO) policy 

• 9 company holidays plus 1 floating holiday  

Extras that Make Life Easier 

• College savings and student loan repayment assistance 

• Monthly cell phone stipend 

• Access to wellness programs at no cost if enrolled through Medical plan including: 
  • Gym membership reimbursement 
  • LiveHealth Online virtual care 
  • Personalized support from a Well-being Coach  

• Employee Assistance Program at no cost 
  • Free confidential counseling and emotional support services  
  • On-demand access to Emotional Well-being resources (ranging from relaxation techniques to stress management)  

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.  

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. 

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 in-person requirements in accordance with your location. 

Work Authorization & Sponsorship 

At this time Sia does not intend to employ any applicant who will require either now or in the future employment visa sponsorship or sponsorship for work authorization (i.e. H-1B visa F-1/OPT or STEM OPT TN etc.).

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. 

Remote Work :

Yes

Employment Type :

Full-time