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