Principal Scientific Advisor

Job description

For 75 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 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.

**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development.

They partner with their colleagues across the company to develop and drive strategies and to set global standards.

The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.

**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 20,000 employees within 110 facilities in over 20 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We're committed to providing benefits that elevate your quality of life.

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, and work life balance flexibility.

**Equal Employment Opportunity**

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com.

This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

229053

Required Skill Profession

Other General