Job Overview

We are seeking an experienced nonclinical drug development professional to serve as a Senior Principal Scientific Advisor within our Safety Assessment business units.

The Scientific Advisory Services team is seeking an experienced professional to provide strategic scientific guidance for the advancement of innovative medicines from discovery through first-in-human (FIH) studies and clinical development. This position provides opportunities for independent scientific guidance and leadership within multidisciplinary project teams and across functional areas. The role focuses on developing and implementing nonclinical pharmacology and toxicology strategies that support key development milestones, regulatory interactions, and domestic and global registration objectives. Responsibilities span a broad range of advanced therapeutic modalities, including cell and gene therapies, oligonucleotides, RNA-based therapeutics, antibody-drug conjugates (ADCs), bispecific antibodies, and other advanced and emerging platforms. Expertise in designing and executing integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, and translational sciences is essential. Success in this role requires a strong understanding of global regulatory expectations, sound scientific judgment, and the ability to deliver innovative, risk-based strategies.

This individual will work closely with current and potential clients and internal Charles River functional groups. The person may act as the scientific leader within cross-functional teams to integrate discovery and safety programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports. This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products. There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will 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.

In addition to providing scientific and regulatory support in client interactions, the individual will have the ability to an expanded breadth of experience in covering multiple drug modalities and be able to contribute solutions to complex scientific and regulatory issues when situations occur during the conduct of a drug development program. They will be able to lend support to multiple divisions of CRL and assume leadership roles in multidisciplinary teams when required. Within Charles River, the individual will be able to provide pivotal leadership and guidance to internal working groups, projects, and/or marketing activities when requested.

This position will mainly support potential clients generally located in the Eastern through Pacific Time Zones.

Job Qualifications

The following are minimum requirements related to the Senior Principal Scientific Advisor position.

• Education: master's degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).
• Experience: 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. Prior direct experience in interacting with regulatory agencies is preferable. Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful.
• Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred.
• Other: 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.

Compensation Data

The hiring range for this position in the United States is $220,000/yr - $240,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, location and any collective agreements, if applicable. Remote candidates located outside the United States should be aware that the relevant pay range varies based on country and location.

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.