Please note that this position is based in either San Diego, CA. 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.

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
• Helps support preparation of reports and regulatory documents for IND and NDA submissions
• Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, 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 initiating/attending 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
• 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

• PhD or DVM in a relevant discipline in a 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
• 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 coaching, influencing, facilitation, development, and problem solving
• 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
• Self-motivation and ability to work with limited supervision

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.