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.
A Senior Director, Operations is responsible for providing oversight of and leadership for applicable operational groups. The individual in this role is also responsible, as part of the site leadership team, for guiding the development of the site’s strategic and tactical planning so that a full line of quality products and services is managed in response to customer and industry needs. May be delegated certain test facility management (TFM) responsibilities, as applicable.
- Define, lead, and execute a comprehensive In-Life and Post-Life Operations strategy, in context of the global Charles River DSA vision.
- Supervisory responsibilities in accordance with the organization’s policies and applicable laws to include workforce planning, interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance and completing annual performance review on or before due date; rewarding and disciplining employees; investigating and addressing complaints; and resolving problems.
- Contribute, as a member of the site leadership team, in the development of strategies and tactics to support the mission, vision, values, resourcing, and performance objectives of the site and company.
- Provide leadership for business development, developing and maintaining working relationships with key clients, agencies, and global stakeholders.
- Verify compliance with regulatory requirements, guidelines, and best practices; mentor staff, sharing scientific, organizational, and operational expertise.
- Provide leadership and support to cross-functional teams that work toward enabling successful investigational new drug (IND) applications or new drug application (NDA) submissions.
- Inform internal and external stakeholders of strategy, plans, and changes as needed to provide quality products and services.
- May be delegated certain TFM responsibilities applicable (see detailed role and responsibilities of TFM below).
- Other duties as assigned.
Test Facility Management responsibilities may include:
- Designate a qualified Study Director (SD) before the study is initiated.
- Verify documented approval of the study plan/protocols by the SD.
- Verify that approved study plan/protocol is available to the quality assurance unit (QAU).
- Verify that deviations from Good Laboratory Practices (GLPs) are communicated to the SD and corrective actions are taken and documented.
- Verify that test and reference items/test and control articles or mixtures have been appropriately tested.
- Verify that personnel are able to perform the functions assigned and, where necessary, provide training for these functions.
- Verify maintenance of record of the qualifications, training, experience, and job descriptions for personnel.
- Verify that appropriate and technically valid SOPs to support study personnel responsibilities are established and followed and approve all original and revised SOPs and verify the maintenance of a historical file of SD responsibilities.
- Verify, if the conduct of phases of a study are delegated (i.e., a multi-site study), that a Principal Investigator (PI)/Individual Scientist (IS) is designated, who is appropriately trained, qualified, and experienced to supervise the delegated phase(s) of the study and that replacement of a PI is done according to established procedures, and is documented.
- Verify, if the conduct of phases of a study are delegated (i.e., a multi-site study), that clear lines of communication exists between the SD, PI(s)/IS(s), the QAU(s) and study personnel.
- Reviews and approve the study plan/protocol if required by national GLP regulations.
The pay range for this position is $170,000/yr – $212,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Education and Experience: Bachelor’s degree (Master’s or Doctorate degree preferred) with 20 or more years of relevant experience in biomedical research and at least 15 years in leadership roles with at least 7 years of senior leadership experience; contract research organization experience preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other:
- Demonstrated ability to solve problems, make quick decisions, communicate decisions effectively, and lead/manage staff in a growing, changing environment.
- Demonstrated knowledge of GxPs and industry guidance documents.
- Ability to communicate verbally and in writing at all levels inside and outside the organization.
- Basic familiarity with Microsoft Office Suite.
- Computer skills, commensurate with Essential Duties and Responsibilities, including the ability to learn a validated system.
- Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
- Ability to work under specific time constraints.
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.
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 [email protected]. 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.
