Director of Toxicology

• Location: San Diego
• Type: Direct Hire
• Job #38561

We are seeking a Director of Toxicology for our client in San Diego, CA. This individual will work in the In Vivo/In Vitro Department. Our client is a Contract Research Laboratory that delivers cGMP/GLP biological services to clients in the pharma/biopharma, biotechnology, academic research, medical devices and related industries.

Responsibilities:

• Gather information and provide guidance and answering questions for project teams regarding all testing standards.
• Demonstrates expertise by providing strategic and hands-on management ensuring toxicology studies are conducted in line with appropriate regulatory guidelines and standards (FDA, WHO, GLP, & ISO).
• Lead and/or manage the design, monitoring, and interpretation of In Vitro, In Vivo or pre-clinical safety studies conducted under Good Laboratory Practices (GLP).
• Represent company professionally and is required to effectively author and communicate toxicology information.
• Interact and/or correspond with Regulatory agency reviewers and Key Opinion.
• Provide input into safety-related statements and other documentation for use with the public and the press.
• Provide technical leadership and expertise.
• Gather needed information and identify areas of improvement and be responsible for identifying and/or providing needed training.
• Conduct themselves in accordance with expected BTS leadership behaviors and corporate policies with an expectation to maintain and enhance their technical, professional, leadership and communication skills through continuing education and professional development courses, attendance and participation in scientific conferences and meetings, publication of appropriate work in peer-reviewed journals and other aspects of technical and leadership development.
• Participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures.

Day to day:

• Oversight, directing and managing of all aspects of In-vitro and In-vivo projects including surgeries, necropsies or various end points of study design or validation or execution of Custom Assay or ELISA per sponsor and regulating agencies requirements for various studies concurrently.
• Participate with client meetings and retention.
• Write Study Designs, Quotes (Work Orders), protocols and reports and analyze data as needed.
• Participate with IACUC coordination, generate and submit IACUC protocols.
• Conduct analytical sample evaluations (Hematology, Blood Chemistries and other tests as needed).
• Communicate with current or potential Sponsors.
• Comply with company policies and procedures, objectives, Quality Assurance program, safety and environmental standards.
• Participate with study duties execution including requisition of drug materials/supplies, study book preparation, facilitation and arrangement of study needs and execution following Good Laboratory Practice (as needed).
• Assist in assuring vivarium compliance with IACUC, USDA and OLAW requirements.

Qualifications:

• Educational requirements may vary depending on years of experience, 8-12+ years of experience required at minimum.
• Commitment to follow through on tasks and deadlines with minimal supervision in a safe manner.
• Must have the ability to be an influencer in implementing sound decisions and solving problems. Offer solutions, think logically, and have a quick and retentive memory.
• Must have strong organizational and analytical skills.
• Must be a flexible, self-starting, and self-managing person.
• Quick turn-around requirements on requests and accuracy and thoroughness are critical.
• Ability to maintain confidential information in a professional manner.

Pay Rate: Approx. $250k annually, DOE

Location: San Diego, CA