Executive Director, Toxicology

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and follow us on LinkedIn and X.

 

Position Summary

The Executive Director, Toxicology, will lead the strategic direction and execution of preclinical toxicology at Acadia, playing a critical role in advancing our drug candidates from discovery through late-stage development. This individual will drive the design and oversight of toxicology studies that inform regulatory filings, clinical trial design, and overall program risk assessment. With deep expertise in translational science and regulatory strategy, the Executive Director will partner cross-functionally to ensure timely, high-quality toxicology deliverables that support Acadia’s innovative pipeline.

A collaborative leader and trusted advisor, this individual will mentor a high-performing team, foster partnerships with CROs and external experts, and serve as a key contributor to regulatory submissions and interactions. The ideal candidate brings strong scientific judgment, excellent communication skills, and a proven ability to integrate toxicology insights into program decision-making.

Primary Responsibilities

• Lead the Toxicology function within Translational Sciences, ensuring scientific rigor, regulatory compliance and alignment with program deliverables.
• Mentor direct reports to maintain a high-performing and collaborative team.
• Establish and clearly communicate toxicology strategies to program teams, with associated reduction-to-practice well-defined.
• Oversee the management of toxicology deliverables, supporting both early-stage drug development and later-stage clinical programs.
• Establish productive and collaborative relationships with program collaborators, vendors and consultants to complete toxicology packages in support of early-stage assets.
• Collaborate with Translational Science operations and CROs to establish budgets, timelines, protocol designs and study monitoring as required. Review and finalize study reports.
• Contribute to and drive key document sections for protocols, IBs, regulatory filings (IND, NDA, EMEA) and where necessary participate in regulatory interactions.
• Partner with Clinical Pharmacology to maximize efficiency and success of early-stage clinical study design and decision-making.
• Partner with early-stage program leads to maximize efficiencies of early-stage toxicology analyses and identify mechanism-based toxicities / risks early.
• Proactively identify gaps and emerging risks in development programs, and engage external experts as needed to inform and guide risk management strategies.
• Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/regulatory strategy
• Remain up to date with innovations in the field and integrate as appropriate those that may inform strategic path or technologic implementation.
• Perform other duties as assigned.

Education/Experience/Skills

PhD in Toxicology or related field.  Targeting 15 years of progressively responsible experience conducting toxicology studies within the pharmaceutical or biotech industry, including 10 years in leadership role. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Track record of establishing and mentoring collaborative toxicology teams.
• Proven leadership in toxicology strategy for IND-enabling studies and clinical-stage molecules.
• Successful track record leading the outsourcing and monitoring of toxicology studies, effectively interacting with CRO study directors, collaborators and consultants as needed in data analyses and interpretation for timely delivery of high-quality toxicology study reports.
• Deep knowledge of FDA, EMA, and ICH guidance documents and GLP regulations for the conduct of nonclinical safety st