Principal Scientific Advisor

Job Summary

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

The Scientific Advisory Services team is hiring an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of the development process. This position provides opportunity for independent scientific guidance and leadership roles within project teams and functional areas across the organization, with an emphasis on providing innovative advice on nonclinical (pharmacology and toxicology) drug development programs across a broad spectrum of drug modalities and therapeutic indications.

This individual will work closely with current and potential clients and internal Charles River functional groups to design robust and scientifically sound nonclinical drug development programs. The person may act as the scientific leader for cross-functional teams for integrated 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, including advanced medicinal 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 Time Zone. 

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 Testing Facility SOPs and the 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.