Study Director - Lexington, United States - Medix

Description

PRIMARY RESPONSIBILITIES:

1. Provide insights to clients regarding regulatory requirements concerning pre-clinical testing across diverse product categories.
2. Serve as an autonomous Study Director, adhering to relevant Good Laboratory Practices (GLPs).
3. Interpret local regulations and GLPs within specialized domains, leveraging them to enhance service offerings.
4. Grasp the study lifecycle from proposal to report, aiding fellow scientists in its application.
5. Supervise and orchestrate study procedures including protocol development, technical guidance, and reporting.
6. Plan, schedule, and execute studies with minimal oversight from Directors.
7. Apply knowledge across various subcontracted services, scientific fields, and imaging methods, encompassing data reporting.
8. Independently manage client visits, as well as telephone/video conferences.
9. Foster effective communication with both internal and external stakeholders to instill confidence and trust.
10. Undertake studies/projects ranging from basic to moderate complexity.
11. Acquire expertise in a particular area through experience and learning.
12. Possess foundational understanding of Quality Assurance (QA)/Quality Control (QC) processes.
13. Collaborate with veterinary personnel, grasp the IACUC process, and comprehend the Study Director's role in animal welfare.
14. Aid in mentoring junior staff and participate in their training when necessary.
15. Offer guidance to clients and technical teams.
16. Acknowledge project costs' significance and liaise with supervisors and managers on staffing and equipment matters, contributing to proposal development.
17. Attend scientific gatherings, conferences, and training sessions to refine professional skills, presenting research where applicable and publishing in peer-reviewed journals.
18. Champion the exploration of new scientific business domains and services.
19. Fulfill additional duties as assigned.

ADDITIONAL REQUIREMENTS:

• Proficient in verbal and written communication.
• Strong client relationship management skills, encompassing planning, interaction, and administrative duties.
• Demonstrated analytical and problem-solving capabilities.
• Competence with computers and standard software applications.
• Familiarity with GLP regulations.
• Excellent organizational skills with a knack for meeting deadlines.
• Ability to interact effectively with personnel at all levels.
• Proven leadership abilities, capable of directing team efforts efficiently.

QUALIFICATIONS:

• Education: Advanced degree in a relevant scientific field or equivalent experience.
• Experience: 1-2 years with a DVM or PhD; 2-5 years with a Masters Degree; 5+ years with a Bachelors Degree, preferably in a pharmaceutical or contract laboratory setting.
• Certification/Licensure: Not required.

PHYSICAL DEMANDS:

• Able to conduct laboratory procedures involving talking, hearing, prolonged standing or sitting, data entry, instrument operation, reaching, and working in confined spaces.
• Must wear appropriate Personal Protective Equipment (PPE) per OSHA regulations and company standards.

WORK ENVIRONMENT:

• Combination of animal facilities and laboratories with moderate noise levels and potential exposure to zoonotic agents, hazardous devices, chemicals, and radiation.
• Office environment with minimal noise.

COMMENTS:

• Occasional weekend and/or holiday duties may be required.
• Occasional travel may be necessary.