Senior Clinical Study Manager at Acadia Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Apr, 26

Salary

163600.0

Posted On

24 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Regulatory Knowledge, Project Management, Problem Solving, Interpersonal Skills, Organizational Skills, Communication Skills, Clinical Trial Management

Industry

Pharmaceutical Manufacturing

Description

About Acadia Pharmaceuticals Acadia 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 Princeton, NJ, or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Senior Clinical Study Manager provides end-to-end leadership for the planning, execution, and oversight of clinical trials across Phases 1-4, as applicable. This role is accountable for ensuring studies are conducted in full compliance with clinical protocols, company SOPs, applicable global regulations, and the principles of Good Clinical Practice (GCP). Serving as a key operational leader, the Senior Clinical Study Manager drives study delivery through close partnership with cross-functional stakeholders and external vendors, balancing quality, timelines, and budget to achieve study objectives. This individual plays a critical role in study strategy, execution, and inspection readiness, bringing a proactive, solutions-oriented approach to complex clinical development programs. The ideal candidate is a highly organized, collaborative leader with deep clinical operations expertise, strong regulatory knowledge, and the ability to manage multiple priorities in a fast-paced, global environment while maintaining a relentless focus on quality and patient safety. Primary Responsibilities Manages overall execution of study conduct by leading clinical study teams and represents clinical operations on multi-functional project teams, both internally/externally. Assists in the design/review of clinical protocols, informed consent documents, and trial case report forms. Oversees external vendors to ensure execution against timelines and budget, and appropriate address of quality issues. Prepares or reviews (if CRO engaged) all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Protocol Deviation Management Plan, Monitoring Plan, TMF Plan) etc. and ensures cross-functional alignment. Drives study start-up, enrollment and closeout for the protocol(s). Liaises with other functional groups to ensure timelines, budgets and study objectives are met. Provides clinical trial status updates to project teams and management. Manages the clinical study budgeting and site contracting process with the legal team. Ensures and actively monitors and manages the internal/external study team to be in a state of inspection readiness. Leads or provides oversight with the planning and execution of study meetings, including relevant investigator meetings. Responsible for identifying vendor issues and ensuring any relevant actions. Responsible for maintaining tracking tools are in an up-to-date status (e.g., CTMS, CT.gov). As needed, trains and mentors junior staff in study management skills and tasks. Other duties as assigned. Education/Experience/Skills Bachelor’s degree in life science or related field. Targeting 5 years of progressively responsible experience in clinical trial management. An equivalent combination of relevant education and experience may be considered. Key Skills: Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills. Ability to work with a diverse team of individuals, often in a global capacity, where sensitivity, respect and an appreciation for different working norms may be present. Practical experience in clinical trial methods and processes; strong knowledge of clinical trial design. Knowledge of local and global regulatory pharmaceutical requirements by providing timely and quality support of regulatory submissions. Clinical study management or project management experience desired. Demonstrated technical, administrative, problem solving and project management experience. A solutions-oriented approach to working cross-functionally with a team of individuals to deliver stated goals and objectives. Must be able and willing to travel on occasion, up to 25%. 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. #LI-SW1 #LI-HYBRID 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. Salary Range $131,000—$163,600 USD What we offer US-based Employees: Competitive base, bonus, new hire and ongoing equity packages Medical, dental, and vision insurance Employer-paid life, disability, business travel and EAP coverage 401(k) Plan with a fully vested company match 1:1 up to 5% Employee Stock Purchase Plan with a 2-year purchase price lock-in 15+ vacation days 13 -15 paid holidays, including office closure between December 24th and January 1st 10 days of paid sick time Paid parental leave benefit Tuition assistance 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. 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 Serbia within 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.

Responsibilities

The Senior Clinical Study Manager leads the planning, execution, and oversight of clinical trials across Phases 1-4, ensuring compliance with protocols and regulations. This role involves managing study teams, liaising with stakeholders, and overseeing vendor performance to meet study objectives.