Associate Director Toxicology

About the role

The Associate Director will oversee preclinical safety assessment/toxicology deliverables, contributing to the research and development of products, projects, and programs in support of the pipeline. They will collaborate cross-functionally to conduct basic research and development, including designing and overseeing preclinical safety and toxicology studies.

Responsibilities

• Plans experimental safety assessment/toxicology programs, including design, logistics, resource allocation, and schedules.
• Oversees scientific management of preclinical safety assessment/toxicology studies, spanning lead optimization through IND and NDA submissions and nonclinical post-marketing approval requirements.
• Maintains oversight of test compound delivery, shipment, and supply requirements.
• Works cross-functionally on projects, including understanding when broader discussions are required and organizing ad hoc working groups as needed.
• Communicates project status and proactively identifies issues to ensure 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.

Requirements

• BS or MS in a relevant discipline or a related field
• Targeting 6-8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry
• DABT Certification strongly preferred
• 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 team’s ability to achieve goals and meet timelines/deliverables

Qualifications

• BS or MS in a relevant discipline or a related field
• Targeting 6-8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry
• DABT Certification strongly preferred
• 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 team’s ability to achieve goals and meet timelines/deliverables

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 team’s ability to achieve goals and meet timelines/deliverables

Benefits

Competitive base salary, discretionary bonus, and equity awards based on individual and organizational performance. Additional benefits include:

• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

Pay

Competitive base salary, discretionary bonus, and equity awards based on individual and organizational performance.

Schedule

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.