Associate Director Toxicology

Role Summary

The Associate Director will oversee Translational Science preclinical safety assessment/toxicology deliverables, ensuring functional interdependence and critical path activities are understood. The role contributes to the research and development of products, projects, and programs in support of the pipeline, collaborating cross-functionally to design and oversee preclinical safety and toxicology studies. It will ensure timely communication of project status and issues to drive alignment and successful completion of team goals and regulatory deliverables. This position can be based in San Diego, CA; San Francisco, CA; or Princeton, NJ with a hybrid schedule requiring in-office presence three days per week on average.

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.

Qualifications

• Required: BS or MS in a relevant discipline or related field; targeting 8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry.
• Preferred: DABT Certification strongly preferred.
• Equivalent combination of relevant education and experience may be considered.

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 various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research, and the ability to evaluate advantages and disadvantages of each for applicability to the research.
• 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 team’s ability to achieve goals and meet timelines/deliverables.

Education

• BS or MS in a relevant discipline or related field.

Additional Requirements

• Must be able and willing to travel as needed.
• Physical demands: 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.