Principal Consultant - Nonclinical Product Development

Sia•Elkridge, MD

15d•$168,300 - $219,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.

Benefits

Competitive Compensation
Annual base salary starting at $168,300-$219,00 (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)