FOR IMMEDIATE CONSIDERATION
BTS Research a well-established, diverse, stable yet growing CRO in beautiful San Diego is seeking a highly motivated, detail orientated, well organized, and highly skilled Toxicologist who loves overcoming challenges, enjoys creating and maintaining positive team relationships and shares our passion for innovation, quality work and producing results. This position will assist in directing the design and management of pre-clinical toxicology studies and other safety studies as well as IND enabling activities.
DUTIES & RESPONSIBILITIES INCLUDE:
- Conduct product safety and health risk assessments on the range of products and components through all phases of IND development.
- Represent BTS on multi-functional teams and serve as primary toxicology liaison.
- 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)
- Demonstrate your expertise in initiating and managing contracts in conjunction with finance group and coordinate activities with academic collaborators for preclinical development in the areas of toxicology, pharmacology, and pharmacokinetics.
- 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 BTS 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.
SUPERVISORY SKILLS & RESPONSIBILITIES
- Provides supervision to and develops associates, establishing performance standards and reviewing performance for assigned personnel.
- Experience in leading a team.
- Travels between BTS facilities.
- May travel to clients or potential client’s locations.
Please note that no formal job description or summary is all inclusive. The direction and/or addition of duties and responsibilities are at the discretion of BTS.
KNOWLEDGE, EXPERIENCE & EDUCATION
EDUCATION & CERTIFICATIONS
- Degree in toxicology, biomedical or related field.
- PhD, MD, DVM with 3+ years of relevant experience.
- Certification by the American Board of Toxicology (DABT), and
- Other equivalent health science or medical professional certifications.
KNOWLEDGE & EXPERIENCE
- Accomplished preclinical development scientist with biologics experience.
- Pharmaceutical/biotechnology industry experience with hands-on experience in developing and managing preclinical studies.
- Mastery of preclinical drug development, strategies, practices and FDA regulations.
- Strong interpersonal communication and technical writing skills with demonstrated proficiency in working effectively with technical staff.
- Must be an effective communicator in oral and written communications and correspondence as well as presentation formats.
- Demonstrated ability to effectively communicate and independently manage multiple tasks in a cross functional corporate, academic, or similar setting.
- Comprehensive knowledge of industry standard and emerging safety and risk assessment practices, principles and procedures and related regulatory information.
- Able to demonstrate in-depth knowledge of biologics and related immunological studies.
- Successful track record of IND filings.
- Hands-on experience with all phases of pre-clinical development.
- Well versed with regulations in U.S. and other regulatory requirements.
- Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
- Full time position with a competitive base salary.
- Great benefit package after successful completion of 90-day probationary period.
- Health & Dental
- Paid Time-Off
- Above all a positive supportive company environment.
- Must be eligible for work in the United States of America.
To join our team as a contributing member of our research programs targeted for discovery through IND send your Resume WITH Cover Letter, Salary History & Requirements, AND three (3) professional references (in Word or PDF format) to HR@BTSresearch.com