Principal Consultant - Nonclinical Product Development

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. Here’s a snapshot of the comprehensive benefits you’ll enjoy as part of Sia. 

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)  

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 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 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.