DEPARTMENT: Applied Sciences
REPORTS TO: Director
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).
- Understand local regulations and GLPs as they relate to primary area of focus.
- Understand the study process from proposal to report.
- Oversee and coordinate study conduct (protocol development, technical guidance, and reporting).
- Assist in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager/Director.
- Host client visits and telephone/video conferences as part of a team.
- 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 understand the Study Director role in animal welfare.
- Assist with mentoring of less experienced staff, and may assist with training of scientific/senior scientific associate, as needed.
- Provide advice to clients and to technical teams.
- Understand importance of overall project costs, communicate with the technical supervisor as well as the Scientific Manager on issues of staffing and equipment, and participate 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: 0-1 years experience with a Ph.D.; 1-3 yrs experience with a Master’s Degree; 3+ 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.
If you are interested in this opportunity please send your CV to firstname.lastname@example.org.