Associate Director Toxicology

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Please note that this position can be based inSan Diego CA OR San Francisco CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will be responsible for the oversight of Translational Science preclinical safety assessment/toxicology deliverables with a clear understanding of functional interdependence and critical path activities. The role will contribute to the research and/or development of the products projects and programs in support of the pipeline. Collaborate crossfunctionally to conduct basic research and development including designing and overseeing preclinical safety and toxicology studies in support of diverse projects and long-term company objectives. Ensure timely and effective communication of project status and issues to drive alignment and successful completion of team goals and deliverables.

Primary Responsibilities

Plans experimental safety assessment/toxicology programs to include design logistics resource allocation schedules. Identifies critical support needs and other necessary details to implement the program(s).
Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.
Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.
Manages vendors and consultants encompassing study design detailed coordination of study execution overview of quality compliance and scientific rigor.
Reviews and contributes to preparation of toxicology reports.
Maintains oversight of test compound delivery shipment and supply requirements.
Works cross functionally on projects including an understanding of when broader discussion is required and the organization ad hoc working groups as needed to move project activities forward.
Communicates project status and proactively identifies issues to ensure that project team goals and regulatory deliverables are met.
Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.
Other duties as assigned.

Education/Experience/Skills

BS or MS in a relevant discipline or a related field. Targeting 8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry. DABT Certification strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

Understanding of the drug development process and the principles concepts practices and standards of executing preclinical safety assessment/toxicology strategies.
Knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation including the various experimental designs statistical tools of data analyses software applications available for data manipulation and presentation and instrumentation pertinent to the research and ability to evaluate the advantages and disadvantages of each in terms of applicability to the research at hand.
Knowledge of the preclinical study types necessary during drug development including acute and chronic toxicology safety pharmacology developmental and reproductive toxicology genotoxicity and carcinogenicity.
Experience working in cross-functional project teams and in a semi-virtual environment including CROs and academic collaborations.
Study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.
Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy quality and compliance.
Knowledge and understanding of GLP ICH and FDA guidance and other relevant regulations and guidelines.
Demonstrated skills and abilities in influencing facilitation development and problem solving. Ability to elicit cooperation from a wide variety of sources and to be influential encouraging and motivating.
Excellent communication presentation consultative partnership and interpersonal skills. Self-motivated and able to work with limited supervision.
Ability to learn understand and apply new technologies strategies and approaches that enhance the teams ability to achieve goals and meet timelines/deliverables.
Must be able and willing to travel as needed.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

Required Experience:

Director

Please note that this position can be based inSan Diego CA OR San Francisco CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Associate Director will be responsible for the oversight of Translational Science preclini...