Note: The job is a remote job and is open to candidates in USA. Charles River Laboratories is a contract research organization providing discovery, safety assessment, and drug development services. The Senior Principal Scientific Advisor provides strategic scientific and regulatory guidance for nonclinical drug development programs, leads multidisciplinary teams, supports client and internal interactions, and develops risk-based strategies for novel therapeutic modalities.

Responsibilities

• Provide strategic scientific guidance for the advancement of innovative medicines from discovery through first-in-human (FIH) studies and clinical development
• Develop and implement nonclinical pharmacology and toxicology strategies that support key development milestones, regulatory interactions, and domestic and global registration objectives
• Design and execute integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, and translational sciences
• Work closely with current and potential clients and internal Charles River functional groups
• Act as the scientific leader within cross-functional teams to integrate discovery and safety programs
• Perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports
• Provide recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products
• Provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products
• Support department leadership regarding strategy and recruitment
• Work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients’ business and scientific needs are understood and efficiently addressed
• Provide scientific and regulatory support in client interactions
• Contribute solutions to complex scientific and regulatory issues when situations occur during the conduct of a drug development program
• Lend support to multiple divisions of CRL and assume leadership roles in multidisciplinary teams when required
• Provide pivotal leadership and guidance to internal working groups, projects, and/or marketing activities when requested

Skills

• Master's degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.)
• Minimum 20 years' experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 12 years nonclinical drug development experience
• Must have direct experience in regulated toxicology and drug development
• Applied understanding of regulatory requirements for the conduct of nonclinical safety assessment studies including Good Laboratory Practices (GLPs)
• Deep understanding of relevant regulatory guidance documents is essential
• Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development
• Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations
• Prior direct experience in interacting with regulatory agencies is preferable
• DABT, DACVP or European Registered Toxicologist preferred
• Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful

Benefits

• Based on your position these may include: bonus/incentives based on performance
• 401K
• Paid time off
• Stock purchase program
• Health and wellness coverage
• Employee and family wellbeing support programs
• Work life balance flexibility
• Remote work arrangement

Company Overview

Company H1B Sponsorship