Scientist II/Study Director

DEPARTMENT: Applied Sciences

REPORTS TO: Director


This person will act as a Scientific Leader responsible for overseeing and expanding specific services in the CBSET portfolio. The individual will be recognized by Sponsors for specific historical knowledge in successful conduct of pre-clinical GLP studies required to complete a variety of IND and IDE submissions for specific therapeutic areas. The individual will advise clients on regulatory requirements and FDA expectations for conduct of pre-clinical studies on new products, and ensure most recent FDA requirements are proposed. These responsibilities involve communication with sponsor representatives, including strong knowledge of operational study costs, while assessing the impact of proposed scope changes on budgets and operations to ensure the best scientific and most cost effective approach is proposed. The individual will participate in FDA pre-submission calls and meetings in support of pre-clinical study designs, and articulate the basis of the study designs proposed by CBSET.

As a Study Director, the individual will be responsible for developing study protocols, IACUC protocols, study plans, and treatment matrices, while coordinating with technical teams to allow appropriate execution of the study, including establishing study schedules. The role also includes helping to develop new Standard Operating Procedures for the introduction of new techniques to enable expansion of services. This individual will be responsible for overall interpretation of preclinical study data, evaluation, and preparation of study reports.

Also, this person will apply a broad range of scientific disciplines and concepts for the preclinical assessment of various treatment modalities, including pharmaceuticals and medical devices. Position requires individual be adept at researching published techniques, and applying general and specific scientific approaches in diversity of therapeutic areas.

  • Provide client insight into regulatory requirements around pre-clinical testing across a broad range of products.
  • Function as an independent Study Director, in accordance with applicable Good Laboratory Practices (GLPs).
  • Understand local regulations and GLPs as they relate to primary area of focus, while applying these to expand service portfolios.
  • Understand the study process from proposal to report, and help other scientists in applying this knowledge.
  • Oversee and coordinate study conduct (protocol development, technical guidance, and reporting).
  • Conduct study planning, scheduling, and execution under minimal Director supervision.
  • Understand application of a broad range of subcontracted services, scientific disciplines, and imaging modalities, including reporting of data from these disciplines.
  • Host client visits and telephone/video conferences independently.
  • Effectively communicate with internal and external clients in a manner that generates confidence and builds trust.
  • Work on studies/programs of basic to moderate complexity.
  • Gain experience and begin to develop an area of expertise.
  • Basic knowledge of Quality Assurance (QA)/Quality Control (QC) process.
  • Interact with veterinary staff, understands the IACUC process, and understands the Study Director role in animal welfare.
  • Assist with mentoring of less experienced staff and may assist with training scientific/senior scientific associate, as needed.
  • Provide advice to clients and to technical teams.
  • Understand importance of overall project costs and communicate with the technical supervisor, as well as the Scientific Manager on issues of staffing and equipment, while also participating in proposal development.
  • May attend scientific meetings, conferences, and training courses to enhance job and professional skills, and present scientific research in public forum and/or scientific meetings, publish scientific data in appropriate peer reviewed journals.
  • Promote new scientific business areas and services.
  • Perform other related duties as required.
  • Excellent verbal and written communication skills
  • Excellent client relationship skills including planning, client interaction, and fulfilling administrative responsibilities
  • Demonstrated analytical and problem solving abilities
  • Proficiency with computers and standard application software
  • Knowledge of GLP regulations
  • Excellent organization skills and the ability to meet deadlines
  • Ability to interact appropriately with all levels of employees
  • Proven leadership skills and the ability to work effectively with, and direct the efforts of team members
  • Education: Advanced degree in related scientific discipline or equivalent experience
  • Experience: 1-2 years experience with a DVM or PhD; 2-5 years experience with a Master’s Degree; 5+ years experience with a Bachelor’s Degree, preferably in a pharmaceutical or contract laboratory environment.
  • Certification/Licensure: N/R
  • Must be able to perform laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
  • Animal facility and laboratories with moderate noise possible and exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades, etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.) and/or radiation.
  • Office working environment with quiet noise conditions.
  • May require occasional duties on weekends and/or holidays.
  • May require occasional travel.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

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