Toxicologist Principal Study Director

Summary

Under the guidance of the Director, In Vivo Pharmacology, the Principal Scientist will be responsible for the comprehensive design, planning, and execution of in vivo studies. The Principal Scientist will be responsible for the design, conduct, execution and reporting of pre-clinical studies and other research projects, with a strong emphasis on business acumen, including study design, protocol writing, resource allocation, and labor management. This role demands strong leadership and regulatory compliance skills to ensure the successful execution of studies in alignment with GLP and non-GLP guidelines.

Study Design and Execution - 40%

• Serve as the primary Study Director for pre-clinical studies and other designated research projects.

• Develop, review, and endorse study protocols, amendments, and schedules in accordance with regulatory guidelines and client specifications.

• Utilize business acumen to ensure accurate study quotations, efficient resource allocation, and effective protocol management.

• Maintain strict adherence to protocols, SOPs, and relevant regulatory standards throughout the study lifecycle.

• Act as the principal liaison for communication between clients and internal departments.

• Lead pre-initiation meetings and other study-related discussions.

• Oversee the preparation and finalization of comprehensive study reports, ensuring accuracy and completeness.

• Manage study files, documenting all correspondence, schedules, and protocol deviations.

• Provide timely and professional responses to audit reports and client inquiries.

• Oversee anesthesia administration, euthanasia procedures, and the handling of biological samples, ensuring proper storage and disposal.

• Provide technical expertise in drug formulation, dosing techniques, and necropsy.

Client interaction and Promotion -25%

• Work with customers to refine study design

• Be a subject matter expert on standard toxicology studies

• As required prepare new marketing on promotional materials or review said material for scientific content

Leadership and Mentorship - 20%

• Mentor and train technicians and staff in advanced laboratory techniques and procedures.

• Foster a culture of innovation, cross-cultural sensitivity, and a positive working environment.

• Lead and manage complex projects, ensuring efficient study design and execution.

• Provide guidance in monitoring animal health and welfare, adhering to the highest ethical standards.

• Collaborate with researchers in both the In Vivo & In Vitro departments and other team members to design and execute studies that align with research objectives and business goals.

• Offer input and expertise in the development of research proposals and grant applications.

Compliance & Regulatory Affairs - 15%

• Ensure compliance with all relevant GLP and non-GLP regulations, guidelines, and ethical standards.

• Work closely with Quality Assurance & Compliance professionals to prepare and submit documentation for regulatory approvals.

• Play an active role in USDA and FDA inspections, ensuring all study activities meet federal regulatory standards.

• Participate in AAALAC inspections, to support the maintenance of accreditation standards for laboratory animal care.

• Effectively collaborate with the Institutional Animal Care and Use Committee (IACUC) to review and gain approval of Animal Care and Use Protocols (ACUPs).

• Author, review, and edit SOPs to standardize laboratory practices, including EHS considerations.

• Maintain meticulous laboratory records, ensuring accurate and up-to-date documentation.

Additional Responsibilities:

• Participate in EHS assessments, risk assessments, and audits, promoting a safe and compliant laboratory environment.

• Contribute to EHS initiatives and improvements, fostering a culture of safety and environmental responsibility.

· Profound knowledge of advanced in vivo pharmacology techniques, including dosing, blood collection, animal preparation, and surgical procedures.

· Strong understanding of GLP and non-GLP data documentation, animal health evaluation, drug formulation, and anesthesia monitoring.

· Expertise in developing and interpreting complex research protocols.

· Proficiency in data review, analysis, and report preparation.

· Excellent leadership, mentorship, and training skills, with a focus on fostering a collaborative and innovative work environment.

· Ability to manage multiple complex projects simultaneously, ensuring efficient and effective execution.

· Strong organizational skills, with meticulous attention to detail in documentation and record-keeping.

· Proficiency in Microsoft Office Suite, specifically Word, Excel, Outlook, and general internet usage for business purposes.

· Knowledge of Animal Care and Use Protocol (ACUP).

· Knowledge of biohazardous materials and their handling.

· Knowledge of euthanasia of laboratory animals and disposal of carcasses, biohazardous, and chemical waste following established procedures.

· Knowledge of technical skills related to the job, such as spreadsheet building, coding, programming, and operating equipment.

• Ability to keep abreast of the latest technology in relationship to his/her position.

• Ability to adapt to changing procedures, policies, and work environment.

• Ability to compose clear, concise, and professional written communication.

• Ability to demonstrate strict attention to detail when performing clerical tasks to avoid making mistakes.

• Ability to meet deadlines and work under pressure.

• Ability to be flexible and adaptable with workload and to shift priorities as needed.

• Ability to understand and follow posted work rules and procedures.

• Ability to demonstrate a high level of cross-cultural sensitivity.

• Ability to demonstrate honesty and integrity by respecting the opinions and ideas of others and maintaining open, honest, and trustworthy communication.

• Ability to maintain safety and study quality.

• Ability to be signed off for unsupervised tasks.

• Ability to communicate in an effective and timely manner.

• Ability to maintain positive interaction with co-workers.

• Ability to provide guidance to other lower-level study personnel.

• Ability to train others in required techniques.

• Ability to dose and collect blood in various animals.

• Ability to prepare study books including forms and labels.

• Ability to update records in track medium as needed.

• Ability to exercise good document practices and good lab practices (GLP).

• Ability to write Animal Care and Use Protocol (ACUP).

• Ability to work occasional weekend, early morning, or late-night shifts as required.

Minimum Education and Experience:

• Diplomate of the American Board of Toxicology (DABT) required.

• 5 years of practical experience in an animal-related field.

Preferred Education and Experience:

· Demonstrated expertise in Investigational New Drug (IND) application preparation and filing process.

• DEA certification for handling-controlled substances.

• Certified Laboratory Animal Technologist (LATG) through the American Association for Laboratory Animal Science (AALAS) or equivalent advanced certifications

· Project management certifications, such as Project Management Professional (PMP) or Certified associate in project management (CAPM).