Role summarythe 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.responsibilitiesinterpret nonclinical data and translate findings into clinical pharmacology development plans that position acadia programs for successful clinical transitionsdesign 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 volunteersdevelop and review study protocols, statistical analysis plans, and tables, listings, and figures (tlfs) for phase i studiesrepresent translational sciences / clinical pharmacology within asset teamssupport regulatory submissions including ind enabling packages, ndas, maas, and ndssacquire and maintain knowledge of national and international regulatory guidelinescollaborate effectively with multidisciplinary teams including clinical, regulatory, nonclinical, and cmc functions to ensure alignment and integration of clinical pharmacology strategiesensure compliance with gcp, ich guidelines, and internal standard operating procedures (sops) for all clinical pharmacokinetic-related studieswork with the quality assurance team on sop development, revision, and implementationevaluate licensing and partnership opportunities, with a focus on clinical pharmacology aspectsother duties as assignedqualificationstargeting 10 years of relevant industry experience, including all aspects of drug development. An equivalent combination of relevant education and experience may be considered.skillstrack record of successful design and execution of phase i studiesproven success in the design and selection of endpoints for poc studies in healthy volunteersdeep knowledge of requirements for clinical pharmacology-related regulatory submissions (ind, nda/maa/nds), with hands-on filing experienceexperience in rare disease is a strong plusstrong analytical and problem-solving skills, with the ability to integrate multifactorial inputs into clear and actionable strategiesstrong organizational skills and able to effectively multitask and prioritizeexcellent interpersonal skills, with the desire to work as part of a multi-functional teamexcellent written and verbal communication skillsexcellent trouble-shooting and decision-making skills; able to listen to and consider different functional perspectives and elevate response to situations when appropriateability to identify inconsistencies and ensure accuracy in all aspects of workeducationph.d. in pharmacology or related fieldadditional requirementstravel: must be able to travel on occasionphysical 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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