Req ID #: 52897
Horsham, PA, US, 19044-1241
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.
Assists departmental supervisor to oversee the quality, integrity and quantity of scientific studies performed and reported within the department; financial review and budgeting; management of scientific staff within the department and the identification and marketing of scientific disciplines. Recognized within the site as an expert in a given field of toxicology. Promotes, implements and ensures maintenance of efficient processes and procedures to provide high quality standards of study design and timely reporting within or across specialized areas of professional expertise.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Meets all expectations related to essential duties and responsibilities of Senior Research Scientist and demonstrates people management skills as described in Appendix 1.
- Provides support for management of departmental staff. May have direct reports.
- May have some Test Facility Management (TFM) responsibilities as accordingly designated/delegated which may include:
- Designating a qualified study director before the study is initiated.
- Replacing the study director promptly if it becomes necessary to do so during the conduct of a study according to established procedures that require the replacement be documented.
- Assuring documented approval of the Study Plan/Protocols by the Study Director.
- Assuring that the Study Director has made the approved Study Plan/Protocol available to the Quality Assurance Unit.
- Assuring that any deviations from Good Laboratory Practice (GLP) regulations involving Study Director responsibilities by the Quality Assurance Unit are communicated to the Study Director and corrective actions are taken and documented.
- Assuring that test and reference items/test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
- Assuring that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
- Assuring the maintenance of a record of the qualifications, training, and experience and job description for each individual.
- Assuring that appropriate and technically valid Standard Operating Procedures to support Study Director or Principal Scientist or Individual Scientist responsibilities are established and followed, and approve all original and revised Standard Operating Procedures.
- Assuring the maintenance of a historical file of all Study Director responsibilities.
- Assuring, in the event that the conduct of phases of a study are delegated (i.e., a multi-site study), that a Principal Investigator/Individual Scientist is designated, who is appropriately trained, qualified, and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator shall be done according to established procedures, and should be documented.
- Assuring, in the event that the conduct of phases of a study are delegated (i.e., a multi-site study), that clear lines of communication exist between the Study Director, Principal Investigator(s)/Individual Scientist(s), the Quality Assurance Unit(s) and study personnel.
- Reviews and approve the Study Plan/Protocol if required by national GLP regulations.
- Helps coordinate the training, performance evaluation and professional development of scientific staff/study directors within the department as well as development of cross-training scientific staff. Assists with various aspects of the day to day management of the study directors and administration within the department (including timesheet review, workload management, absences, vacations, disciplinary actions). May assist supervisor (Director or above) in the salary administration of scientific staff.
- Along with other departmental scientists, may provide guidance for technical quality for area of specialization by interacting with research support and technical groups (i.e., technical operations, data coordination, laboratories and Business development/marketing) that directly impact the quality, success, and growth in area of specialization.
- Contributes to review and/or quality of designated area Study Plans/Protocols and reports produced by the department and internal contributing scientists’ reports, as appropriate.
- Helps ensure departmental policies, practices and procedures adhere to regulatory and Animal Welfare guidelines and requirements applicable to the conduct of safety assessment studies.
- Helps ensure report timelines are maintained and work is conducted to ensure high quality study design and timely reporting.
- Serves as a key point of contact for data interpretation of study results through data review meetings and/or review of reports.
- Helps determine scientific staffing requirements within the department in conjunction with supervisor.
- Can function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs) (see detailed role and responsibilities of Study Director below).
- Where applicable, functions as Principal Investigator(PI)/Individual Scientist(IS) (see detailed role and responsibilities of PI/IS below).
- Assists in validations or provides support for validations needed for specialty area.
In support of departmental supervisor, scope of responsibilities may vary to include contributions towards:
- Providing guidance to Sponsors for development of studies and programs.
- Interacting with Client Services for study planning, bid and LOPA generation, and securing study awards.
- Interacting with BD/Marketing as needed to ensure proper and adequate representation of area capabilities to potential clients.
- Area specific training sessions for BD/marketing staff upon request.
- Directly participate in sales & marketing efforts (e.g. presentations within or across sites).
- May serve as liaison for area related consultants (helps identify, schedule/facilitate contracts with new and existing consultants, etc).
- Interacting with other Scientific staff and Directors overseeing similar areas of specialty across sites to contribute to developments and help ensure cohesive cross-site interactions.
- Interacting extensively with Sponsors during initial inquires for program-related studies, in support of site visits, and at professional meetings.
- Attending scientific meetings, symposia or workshops and publishes or presents results of the research whenever possible. Periodically presents internally to the scientists as part of training efforts.
- Assist in preparation of annual budgetary expectations and/or results for the designated area of responsibility/department for local site and/or cross-site specialty area financial planning.
- Review and monitoring of the accuracy and completeness of Project cost estimates and the timely communication of pricing information to the Sponsor through Marketing, where applicable.
- Support, identify and contribute to development of novel scientific disciplines along with scientific team, coordinates their marketing by providing information packages and targeting appropriate clients for sales representative or visiting personally, as necessary.
- Interact with other Scientists or Directors overseeing similar areas of specialty across sites to contribute to developments and help ensure cohesive cross-site interactions and development of complimentary services/capabilities. Promotes integration and harmonization of Program activities across Safety Assessment.
- Contribute to the financial growth opportunities for Charles River Laboratories (CRL) through identification of new trends, technologies, and/or capabilities. Conducts intelligence on status of similar programs at other Contract Research Organizations (CRO’s). Advises Senior/Executive Management of technological advances, and specific resource needs to establish new area and maintain competitive advantage.
- Contribute to Strategic Planning locally and may contribute to Global Strategic Planning discussions
Definition of Role/Responsibilities of Study Director:
- Designs, writes, reviews and edits, as necessary, Study Plans/Protocols, amendments and study schedules that define and schedule all study activities.
- Oversees and coordinates all aspects of study procedures, whether performed within the department or by service departments.
- Ensures that projects are performed according to Standard Operating Procedures and Good Laboratory Practice regulations and is aware of appropriate regulations, guidelines and guidances.
- Writes, reviews and edits, as necessary, draft or final reports that document all study related procedures and results.
- Prompt verbal or written communication with Sponsors on study related business.
Definition of Role/Responsibilities of PI/IS:
- Reviews and provides edits, as necessary to study plans/protocols and amendments to Study Director for aspects related to the area of contribution in the study.
- Responsible for conduct of designated work in compliance with the Study Plan/Protocol.
- Writes, reviews and edits, as necessary, draft or final contributing scientist reports that document related procedures, results and integrated discussion.
- Oversees and may coordinate aspects of procedures in the area of specialization, whether performed within the department or by service departments.
- Responsible for scientific aspects of the area of specialization in the department/division.
- Education: Bachelor’s (BSc), Master’s (MA/MSc), Doctorate (PhD), PharmD, DVM, or MD degree or equivalent in Toxicology, Pharmacology, or a related discipline.
- Experience: The candidate at this senior level position will have a proven track record of accomplishments establishing them as an individual with leadership skills, meeting hard and soft skill expectations. Depending on educational background, the candidate will require > 10 years of experience in conducting toxicological research and/or a strong background in the area of specialization. The experience may be gained at Charles River Laboratories Inc. or elsewhere provided that it is judged to be of an equivalent nature.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: TBA
- Other: Summary grid of skills indicated in Appendix 1
- Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
- Must occasionally move about inside the office to access file cabinets, office machinery, etc.
- Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information in these situations.
- The employee must frequently operate a passenger vehicle
- The employee must occasionally lift and/or move up to 10 pounds.
- General office working conditions.
- The noise level in the work environment is usually quiet.
- While performing the duties of this job, the employee may be exposed to animal-related allergens.
- Laboratory and vivarium environment, as required.
- This position may require domestic and international travels.
Designs and/or executes toxicology testing strategies and studies. Provides guidance to Sponsors regarding study design and study endpoints. Writes study protocols and plans. Leads and is responsible for all aspects of the study including in-life, data review and interpretation, communication of results to Sponsors, study updates to the Sponsor, and the draft and final reports. Ensures that all Principal Investigators, Individual Scientists, and all key study personnel are held accountable for the various study components. Ensures compliance with protocols/study plans, applicable SOPs and BOPs, and regulatory guidance documents. Troubleshoots and resolves study issues. Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.
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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 120 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 14,000 employees within 80 facilities in 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
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 is an Equal Opportunity Employer - M/F/Disabled/Vet
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