Sia · 23 hours ago
Principal Consultant - Nonclinical Product Development
Elkridge, MD
Full-time
Hybrid
Lead/Staff
$168K/yr - $219K/yr
10+ years expSia is a next-generation global management consulting group specializing in life sciences and healthcare consulting. The Principal Consultant will provide strategic and operational support for nonclinical product development, guiding clients through product development milestones and ensuring regulatory compliance across various therapeutic modalities.
Artificial Intelligence (AI)Cyber SecurityManagement Consulting
No H1B
U.S. Citizen Only
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
Qualification
Required
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
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
Benefits
3 Medical plans
Dental and Vision
Life, AD&D and other voluntary insurance
401K retirement plan
4% matching and 100% vested upon enrollment
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Health, Dependent Care, Commuter
100% paid parental leave for all new parents with eligible tenure
Building Healthy Families program if enrolled through Medical plan
Generous Paid Time Off (PTO) policy
9 company holidays plus 1 floating holiday
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)
Company
Sia
is a management consulting company. It is focused on delivering superior value and tangible results to clients.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Derek Counihan
Solutions Architect
Recent News
Fintech World Post
2023-09-21
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