Director Clinical Pharmacology

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 Director of Clinical Pharmacology will play a pivotal role in driving Acadia’s early development strategy across multiple therapeutic areas, with a strong emphasis on neuroscience. This strategic and hands-on leader will shape and execute early-phase clinical pharmacology programs, translating nonclinical findings into meaningful clinical outcomes. As a key member of cross-functional Asset Teams, the Director will be responsible for the design and execution of Phase 1 studies, including First-in-Human (FIH), food effect, drug-drug interaction (DDI), and proof-of-concept (PoC) trials in healthy volunteers.

This role demands deep scientific expertise, regulatory fluency, and cross-disciplinary collaboration to inform data-driven decisions and enable seamless progression from discovery to clinical validation. The ideal candidate will bring a proven track record in designing and delivering early development strategies, including biomarker and pharmacodynamic endpoint integration, with the ability to influence program direction and regulatory submissions.

Primary responsibilities

• Interpret nonclinical data and translate findings into clinical pharmacology development plans that position Acadia programs for successful clinical transitions.
• Design and oversee early-phase clinical trials (e.g., FIH, food effect, DDI studies).
• Collaborate with colleagues on the selection and implementation of appropriate biomarker, imaging, and pharmacodynamic endpoints for proof-of-concept (PoC) studies in healthy volunteers.
• Develop and review study protocols, statistical analysis plans, and tables, listings, and figures (TLFs) for Phase I studies.
• Represent Translational Sciences / Clinical Pharmacology within Asset Teams.
• Support regulatory submissions including IND enabling packages, NDAs, MAAs, and NDSs
• Acquire and maintain knowledge of national and international regulatory guidelines.
• Collaborate effectively with multidisciplinary teams including clinical, regulatory, nonclinical, and CMC functions to ensure alignment and integration of Clinical Pharmacology strategies.
• Ensure compliance with GCP, ICH guidelines, and internal Standard Operating Procedures (SOPs) for all Clinical Pharmacokinetic-related studies
• Work with the Quality Assurance team on SOP development, revision, and implementation.
• Evaluate licensing and partnership opportunities, with a focus on Clinical Pharmacology aspects.
• Perform other duties as assigned.

 

Education/Experience/Skills

Ph.D. in Pharmacology or related field.  Targeting 10 years of relevant industry experience, including all aspects of drug development.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Track record of successful design and execution of Phase I studies.
• Proven success in the design and selection of endpoints for PoC studies in healthy volunteers.
• Deep knowledge of requirements for Clinical Pharmacology-related regulatory submissions (IND, NDA/MAA/NDS), with hands-on filing experience.
• Experience in rare disease is a strong plus.
• Strong analytical and problem-solving skills, with the ability to integrate multifactorial inputs into clear and actionable strategies.
• Strong organizational skills and able to effectively multitask and prioritize.
• Excellent interpersonal skills, with the desire to work as part of a multi-functional team.
• Excellent written and verbal communication skills.
• Excellent trouble-shooting and decision-making skills; able to listen to and consider different functional perspectives and escalate response to situations when appropriate.
• Ability to identify inconsistencies and ensure accuracy in all aspects