Study Director – Regulatory Toxicology

We are seeking a Ph.D. and/or M.D., or D.V.M. trained Study Director to support the regulatory toxicology in vivo preclinical services. This position requires in-depth experience serving as Study Director on preclinical studies conducted in accordance with Good Laboratory Practices (GLP). This role also requires familiarity and fluency with the objectives and methodologies of preclinical animal research related to evaluating the efficacy, pharmacology and safety of new therapeutics, medical devices, and drug delivery technologies, ideally including experience with nonhuman primate research.  Proficiency with translational research methods and familiarity with related scientific fields is critical for both effective communication and alignment of company capabilities with study objectives and coordination of data collection and interpretation, as well as management and oversight of project team members delegated specific technical responsibilities.

Responsibilities:

• Provide expertise in design, implementation, and oversight of GLP toxicology studies as Study Director.
• Provide expertise in design, implementation and analysis of in vivo efficacy, PK/PD and toxicology studies.
• Review preclinical data from other test systems to inform nonhuman primate study design.
• Contribute to study design and effective protocol development.
• Oversee study planning, initiation, and study completion activities.
• Provide hands-on technical execution of studies as required.
• Oversee data analysis, study report generation and distribution to clients.
• Develop, approve, and distribute study-related documents and other study tools.
• Serve as point of contact for internal communication regarding all aspects of study execution.
• Act as primary point of contact for sponsor study monitors, providing regular updates.
• Contribute to junior scientific staff development through scientific support and oversight.
• Advance scientific and commercial interactions with existing and new sponsoring organizations.
• Support development of new scientific methodologies and optimization of existing test systems.
• Establish an in-depth knowledge of facility SOPs and contribute to their maintenance.
• Contribution to maintenance of good laboratory practices (GLPs) and AAALAC credentials.
• Present company research capabilities and study outcomes at relevant scientific meetings.
• On-site and off-site client, inspector and vendor interactions.

Education/ Experience Requirements:

• Requires Ph.D. and/or M.D. or D.V.M. degree, with 2 or more years of Study Director experience.
• Minimum of 2 years of laboratory experience working with in vivo models, preferably including nonhuman primate translational models.

Additional Requirements:

• Must be willing to relocate to St. Kitts
• Responsive, proactive mentality.
• Demonstrated ability to adapt to the necessities of fast-paced multi-site research environments.
• Exceptional attention to detail and focus on quality of service and client communication.
• Experience working in a protocol driven environment on in vivo and/or molecular models.
• Experience working with and under IACUC oversight in AAALAC-accredited facilities preferred.
• Must have exceptional interpersonal, communication and presentation skills and comfort interacting with sponsors and leading members of the scientific community.
• Candidates with Study Director experience in two or more of the following areas in addition to toxicology preferred: ophthalmology, immunology, CNS disease, metabolic disease, cardiovascular disease, surgery, molecular biology, cell culture, formulation.
• Experience supervising junior scientists also favored.
• Publication record and demonstrated experience establishing new scientific methodologies.
• Track record of scientific achievement and presentation of findings at scientific meetings.