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 elevate 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
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