Associate Director Toxicology

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Hybrid; USD 155,000 - 193,200; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

Job summary

ACADIA Pharmaceuticals Inc. is seeking an Associate Director based in New Jersey, CA or San Diego to oversee Translational Science preclinical safety deliverables. This role requires collaboration in research and development, driving alignment across projects and ensuring timely communication to meet regulatory deliverables.

The ideal candidate will have at least 8 years of experience in toxicology within the pharma industry. Benefits include competitive pay and a hybrid work environment.

Qualifications

• 8 years of relevant experience in preclinical safety assessment/toxicology.
• DABT Certification strongly preferred.
• Experience in the composition and review of toxicology reports.

Responsibilities

• Manage experimental safety assessment/toxicology programs.
• Provide oversight on scientific management of studies.
• Monitor CROs for quality in studies conducted.

Skills

Understanding of the drug development process

Knowledge of GLP, ICH and FDA guidelines

Excellent communication skills

Cross-functional project team experience

Education

BS or MS in a relevant discipline

Tools

Statistical tools for data analysis

Job description

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's 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 cross‑functionally 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, and 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 of 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 the 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.
• 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.

$155,000—$193,200 USD

What we offer US‑based Employees

• Competitive base, bonus, new hire and ongoing equity packages
• 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

EEO Statement (US‑based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. Acadia is committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally‑protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

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