DEPARTMENT: Applied Sciences
REPORTS TO: Director
Initiate, direct and execute projects of diverse scope both independently, with peer guidance as needed, or as part of a multi-disciplinary team in a GLP environment at CBSET. Develop non-clinical toxicology strategies to advance drug candidates from preclinical to clinical development for CBSET Sponsors. Plan, execute, monitor and interpret toxicology studies for advancing Sponsors drug candidates from lead optimization, to candidate selection including IND-enabling studies, IB, and NDA submissions and interactions with regulatory agencies on Sponsor research. Develop strategies for the application of broad scientific principles and concepts for the preclinical assessment of various treatment modalities, including pharmaceuticals and/or medical devices. Position requires individual be recognized for specific scientific expertise in drug development.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Primary: Responsible for the design, conduct, monitoring and interpretation of discovery and exploratory toxicology studies (in vitro and in vivo) required for lead optimization and safety assessment for CBSET sponsors.
- Secondary: Responsible for the design, conduct, monitoring and interpretation of discovery and safety studies required for device and combination products.
- Develop nonclinical study proposals and protocols to ensure that they fulfill all requirements of the toxicology and/or regulatory program and development plan.
- Maintain a current understanding of toxicology literature, methodology and regulatory requirements.
- Develop and maintain client/sponsor relationships.
- Ensure appropriate data interpretation of the results from nonclinical studies.
- Participate in the research of development and/or validation of new techniques, methods, and technologies.
- Prepare and submit abstracts and support development of manuscripts for publication.
- Present scientific research in public forum and/or scientific meetings, publish scientific data in appropriate peer reviewed journals.
- Promote new scientific business areas and service.
- Perform other related duties as required.
- Excellent verbal and written communication skills
- Excellent client relationship skills including planning, client interaction, and fulfilling administrative responsibilities
- Demonstrated analytical and problem solving abilities
- Proficiency with computers and standard application software
- Knowledge of GLP regulations
- Excellent organization skills and the ability to meet deadlines
- Ability to interact appropriately with all levels of employees.
- Proven leadership skills and the ability to work effectively with, and direct the efforts of, team members
- Education/Experience: Ph.D. in Toxicology or a closely related discipline and DABT board certification preferred but not required. M.S. with a minimum of 10 years of toxicology experience in the Biotech-Pharma or CRO industry working in drug development of small molecule and/or biologics, DABT eligible required.
- Experience in designing, monitoring, and interpreting discovery and exploratory toxicology studies and program to assist lead optimization and candidate selection efforts.
- Strong communication and interpersonal skills with an ability to effectively function within a matrixed environment.
- Familiarity of FDA, EMA, and ICH guidance documents.
- Experience in the writing of regulatory submissions (INDs, DSURs, IBs, and NDAs).
- Critical problem solving and organizational skills required.
- Must be able to perform laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
- Animal facility and laboratories with moderate noise possible and exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades, etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.) and/or radiation.
- Office working environment with quiet noise conditions.
- May require occasional duties on weekends and/or holidays.
- May require occasional travel.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
If you are interested in this opportunity please send your CV to firstname.lastname@example.org.