Director Clinical Pharmacology
ACADIA Pharmaceuticals
San Francisco, CA
About Acadia PharmaceuticalsAcadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we're here to be their difference.Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe 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.Primary 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 assignedEducation/Experience/SkillsPh.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.Key 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 escalate response to situations when appropriateAbility to identify inconsistencies and ensure accuracy in all aspects of workMust be able to travel on occasionPhysical RequirementsThis 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.#transmed#LI-Hybrid #LI-SL1In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.Salary Range $200,000”$249,600 USDWhat we offer US-based Employees:Competitive base, bonus, new hire and ongoing equity packagesMedical, dental, and vision insuranceEmployer-paid life, disability, business travel and EAP coverage401(k) Plan with a fully vested company match 1:1 up to 5%Employee Stock Purchase Plan with a 2-year purchase price lock-in15vacation days13 -15 paid holidays, including office closure between December 24th and January 1st10 days of paid sick timePaid parental leave benefitTuition assistanceEEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn't exactly what we describe here.It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete ourReasonable Accommodation Request Formor contact us attalentacquisition@acadia-pharm.comor858-261-2923.Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.California Applicants: Please see Additional Information for California Residents within our Privacy Policy.Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbiawithin our Privacy Policy.Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (Acadia). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
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