Director Clinical Pharmacology

Acadia Pharmaceuticals•San Diego, CA

11h•Hybrid

About The Position

The Director of Clinical Pharmacology will bring deep expertise across both preclinical and clinical development, with a strong track record of success in advancing drug candidates through early development. This individual will serve as a key representative of the Clinical Pharmacology function on cross-functional Asset Teams and will be responsible for leading early-stage programs. Core responsibilities include the strategic planning and execution of Phase 1 clinical trials, including First-in-Human (FIH) and proof-of-concept (PoC) studies in healthy volunteers. This role supports drug development across multiple therapeutic areas, with a focus on neuroscience.

Requirements

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.
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
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 of work
Must be able to travel on occasion

Nice To Haves

Experience in rare disease is a strong plus

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
Other duties as assigned