Director Clinical Pharmacology

Role Summary

The Director of Clinical Pharmacology will bring deep expertise across both preclinical and clinical development, with a strong track record of advancing drug candidates through early development. This role serves as a key representative of the Clinical Pharmacology function on cross-functional Asset Teams and leads early-stage programs. Core responsibilities include strategic planning and execution of Phase 1 clinical trials, including First-in-Human and proof-of-concept studies in healthy volunteers, with a focus on neuroscience. This position can be based in San Diego, CA; San Francisco, CA; or Princeton, NJ, with a hybrid model requiring in-office work three days per week on average.

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

Qualifications

• Targeting 10 years of relevant industry experience, including all aspects of drug development. An equivalent combination of relevant education and experience may be considered.

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 of work

Education

• Ph.D. in Pharmacology or related field

Additional Requirements

• Travel: Must be able to travel on occasion
• Physical demands: Regular standing, walking, sitting, and the use of hands for handling or operating equipment; may reach, climb, balance, stoop, kneel, crouch; occasional lifting up to 20 pounds; ability to travel independently overnight as required by travel schedules or business needs