Scientist I/Study Director

Description: CBSET is a recognized leader in preclinical biomedical research. We make it our mission to help our sponsors accelerate the development of novel and innovative pharmaceuticals, biotechnologies, and medical devices. CBSET offers extensive regulatory and scientific expertise to the medtech and biopharma industry around the globe in order to rapidly transform early-stage concepts into novel therapies.

We at CBSET are committed to providing exceptional animal care and this can only be achieved through hiring exceptional technical talent. By working as a Scientist, you will be part of a collaborative effort with our clients to advance biomedical research through innovative, high-quality services. In addition, CBSET is proud to offer a generous benefits package, which includes health, dental and vision plans, life insurance, short-term and long-term disability, and an opportunity to participate in a 401(k) plan.

Please be aware that the requirements presented within in this job listing are the basic qualifications required for the Scientist I position; however, job title will be contingent upon the level of experience of the candidate in those requirements.

BASIC SUMMARY: Initiate, direct, and execute projects of diverse scope both independently, and as part of a multi-disciplinary team in a GLP environment. This person will act as a Study Director who is responsible for overseeing the study conduct of in-vivo preclinical safety and efficacy studies. Responsible for developing study protocols, IACUC protocols, study plans, and treatment matrices. Coordinates with technical teams to allow appropriate execution of the study, including establishing study schedules. Ensures adequate Standard Operating Procedures are adhered to, enabling study conduct, including oversight of adequate data recording. Ensures regulatory requirements/expectations are met for the assigned studies. The role requires direct communication with sponsor representatives, including familiarity with study costs, and assessing impact of scope changes on budgets and operations. This individual will be responsible for overall interpretation of preclinical study data, evaluation, and preparation of study reports.

Also, may be involved with development of new technologies/procedures. 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Function as an independent Study Director, in accordance with applicable Good Laboratory Practices (GLPs).

· Understands local regulations and GLPs as they relate to primary area of focus.

· Understands the study process from proposal to report.

· Oversees and coordinates study conduct (protocol development, technical guidance, and reporting).

· Assists in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager/Director.

· Hosts client visits and telephone/video conferences as part of a team.

· Effectively communicates with internal and external clients in a manner that generates confidence and builds trust.

· Works on studies/programs of basic to moderate complexity.

· Gains experience and begins to develop an area of expertise.

· Basic knowledge of Quality Assurance (QA)/Quality Control (QC) process.

· Interacts with veterinary staff, understands the IACUC process, and understands the Study Director role in animal welfare.

· Assists with mentoring of less experienced staff and may assist with training of scientific/senior scientific associate, as needed.

· Provides advice to clients and to technical teams.

· Understands importance of overall project costs and communicates with the technical supervisor as well as the Scientific Manager on issues of staffing and equipment, and participates 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.

OTHER:

· 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.

QUALIFICATIONS:

· Education: Advanced degree in related scientific discipline or equivalent experience.

· Experience: 0-1 yr experience with a DVM or PhD; 1-3 yrs experience with a Master’s Degree; 3+ yrs experience with a Bachelor’s Degree, preferably in a pharmaceutical or contract laboratory environment.

· Certification/Licensure: N/R

PHYSICAL DEMANDS:

· 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.

WORK ENVIRONMENT:

· Animal facility and laboratories with moderate noise possible and exposure to hazardous/noxious devices (e.g., needles, scalpel blades, etc), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc) and/or radiation.

· General office working conditions, with generally quiet noise conditions.

COMMENTS:

· May require occasional duties on weekends and/or holidays.
May require occasional travel.

Job Type: Full-time

Pay: From $110,000.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to Relocate:

• Lexington, MA 02421: Relocate before starting work (Required)

Work Location: In person