Principal Scientific Advisor

Company: Charles River Laboratories, Research Models and Se
Location: Boston
Posted on: February 25, 2021

Job Description:

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary We are seeking an experienced Principal Scientific Advisor for our Discovery & Safety Assessment business.
This position provides scientific leadership within project teams and across functional areas across the organization, but with an emphasis on providing scientific and innovative advice on nonclinical (pharmacology and toxicology) drug development programs. Supports Client Services, Account Management, and Operations by ensuring that clients' business and scientific needs are understood and efficiently addressed. Works closely with Client Services and scientific staff to design complex nonclinical development programs. May act as the scientific leader for cross-functional teams for complex programs. May perform gap analyses, support due diligence procedures, and perform scientific review of Pharm/Tox data or reports. Is recognized throughout the company as a subject matter expert in a particular therapeutic area(s) or for particular class(es) of therapeutic products. Has thorough knowledge of domestic and international regulatory expectations and requirements. Provides intellectual input in determining the appropriate Safety Assessment strategy for complex and novel products including gene and cell therapies. Provides support to department leadership in regard to strategy, marketing and recruitment.
The following are minimum requirements related to the Principal Scientific Advisor position.
--- Education: Master's degree or PhD in relevant discipline (pharmacology, biology, immunology, toxicology, etc). DABT, DACVP or European Registered Toxicologist preferred.
--- Experience: Minimum 15 years' experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 10 years nonclinical drug--development experience. Must have experience in regulated toxicology. Prior experience in program management is considered useful.
--- Certification/Licensure: Certification as appropriate for specialty preferred.
--- Other: Applied understanding of regulatory requirements for the conduct of nonclinical studies including Testing Facility SOPs and the Good Laboratory Practices (GLPs). Understanding of the regulatory environment for GLP studies is required. Deep understanding of relevant regulatory guidance documents is essential. Demonstrated leadership skills in support of intra- and interdepartmental initiatives, Sponsor interactions, and business development. Proficiency in the use of standard software including Microsoft-- Excel, Word, PowerPoint, etc. and standard laboratory calculations.
The following experience related to the Principal Scientific Advisor position is highly desired:
--- Experience in developing nonclinical development programs for advanced medicines (gene and cell therapies) and may include viral products, vaccines and/or antisense oligonucleotide (ASO) therapies.
The candidate for the Principal Scientific Advisor position will ideally be located near a North East Safety Assessment Site (Montreal QC or Mattawan MI), in the Greater Boston area or North America Northeast Region. About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 320 patents and 74 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market. 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. About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 13,000 employees within 80 facilities in 23 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 85% of the drugs approved by the FDA in 2018. Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
Nearest Major Market: Boston
Job Segment: Chemistry, Scientific, Toxicology, Biotech, Consulting, Science, Engineering, Technology

Keywords: Charles River Laboratories, Research Models and Se, Boston , Principal Scientific Advisor, Other , Boston, Massachusetts