Director Clinical Pharmacology

Role Summary

Director of Clinical Pharmacology provides deep expertise across preclinical and clinical development and leads early-stage programs. Acts as a key representative of the Clinical Pharmacology function on cross-functional Asset Teams and drives strategic planning and execution of Phase 1 trials, including First-in-Human (FIH) and proof-of-concept (PoC) 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 three days in the office on average. Must be able to travel on occasion.

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
• Aquire 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.
• 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

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
• 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

Education

• Ph.D. in Pharmacology or related field

Physical Demands

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.