Director Toxicology at Acadia

**Who this is for** This senior leadership position is for a PhD or DVM with extensive experience in toxicology and preclinical safety assessment within the pha

Work type: hybrid

Location: Princeton, New Jersey, United States; San Diego, California, United States; San Francisco, California

Salary: $199,400 – $249,300/yr

Type: Full-time

Summary

**Who this is for** This senior leadership position is for a PhD or DVM with extensive experience in toxicology and preclinical safety assessment within the pharmaceutical industry. You will oversee the development and execution of safety assessment programs to support the company's drug pipeline. **Key highlights** You will be responsible for planning and managing preclinical safety/toxicology studies, monitoring Contract Research Organizations (CROs) for quality and compliance, and preparing reports for regulatory submissions (IND, NDA). The role also involves supporting business development and due diligence. **You might be a good fit if you...** - Hold a PhD or DVM in a relevant discipline with approximately 10 years of relevant experience. - Have a strong understanding of preclinical safety assessment and toxicology study design and execution. - Possess experience in managing CROs and vendors for toxicology studies. - Are skilled in preparing and reviewing regulatory documents and communicating project status to leadership.

Job Description

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

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

Responsible for the oversight of Translational Medicine preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependencies 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. Conducts and collaborates with others on basic research and development including preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Conducts and collaborates with others on basic research and development including designing and monitoring preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Responsible for the communication of project status and issues and develops strategies to ensure project team goals and deliverables are met.

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 to complete Translational Medicine safety assessment/toxicology studies for the various programs.

• Responsible for preparation and review of reports and regulatory documents for IND and NDA submissions. Explore innovative approaches to enhance efficiency of toxicology evaluations.

• Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, identifying gaps, defining additional nonclinical study plans and test compound requirements, and developing overall project timelines and associated budgets.

• Supports Impurity/Degradant safety assessment reviews requested by Chemistry, Manufacturing, and Controls (CMC) groups, involving public domain literature reviews, evaluating structure activity relationships using in silico databases, and competitive intelligence sources.

• Works across functional areas on projects including lleading and participation in team and sub-team meetings and organizing ad hoc working groups as needed to move project activities forward.

• Communicates project status and issues and ensures project team goals and regulatory deliverables are met. Clearly presents data, interpretation and recommendations to R&D leadership.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

PhD or DVM in a relevant discipline or related field. Targeting 10 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development experience within the pharmaceutical or biotech industry. DABT Certification strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Broad 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. Through a complete understanding of the tools and design methods, able to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• In depth 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 managing cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.

• Specific direct 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 leading teams and sub-teams, coaching, influencing, facilitation, development, and problem solving. Passion for science and teamwork with self-motivation and ability to work with limited supervision.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Willing and able to travel as needed.

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.

#transmed

#LI-Hybrid #LI-SL1

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range
$199,400—$249,300 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

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