Senior Principal Scientific Advisor (REMOTE)

Charles River; Wilmington, Northern (MA, KY); Hybrid; USD 220,000 - 240,000; Full time

Benefits offered by this job

Bonus incentives

401K

Health coverage

Stock purchase program

Work-life balance

Job summary

Charles River is seeking a Senior Principal Scientific Advisor to lead nonclinical pharmacology and toxicology programs within Safety Assessment. The role focuses on strategic scientific guidance from discovery through FIH and clinical development, working with multidisciplinary teams and clients.

The ideal candidate has 20+ years in pharma/biotech nonclinical development, direct toxicology experience, and demonstrated leadership in regulatory interactions and program management.

Qualifications

• 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.

Responsibilities

• Provide strategic scientific guidance for the advancement of innovative medicines from discovery through first-in-human (FIH) studies and clinical development.
• Lead cross-functional teams and client interactions to integrate discovery and safety programs.
• Develop and implement nonclinical pharmacology and toxicology strategies that support regulatory milestones and global registration objectives.

Skills

Nonclinical drug development

Regulatory interactions

Project leadership

GLP familiarity

Education

Professional certification: DABT/DACVP/ERTO

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

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Senior Principal Scientific Advisor (REMOTE)

Location: Wilmington, MA, US, 01887 US

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 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.

• 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.

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.

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.

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

Nearest Major Market: Boston
Job Segment: Testing, Pharmaceutical, Laboratory, Scientific, Biotech, Technology, Science, Engineering