Director Toxicology

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.

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.

• 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 leading 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…