Acadia Pharmaceuticals
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 Summary
The 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 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
Education/Experience/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
Must be able to travel on occasion
Physical Requirements
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.
#transmed
#LI-Hybrid #LI-SL1
In 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.
What we offer US-based Employees:
EEO 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 our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
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.
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Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
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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.