Associate Director Clinical Operations

ACADIA PHARMACEUTICALS INC

Princeton, NJ

Apply

JOB DETAILS

SALARY

$147,900–$184,900 Per Year

SKILLS

Administrative Management, Alzheimer's, Biology, Biotech and Pharmaceutical, Budget Management, Budgeting, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Trial, Clinical Trial Management, Communication Skills, Computer Skills, Conduct Studies, Contract Research Organization (CRO), Cross-Functional, Dementia, Dental Insurance, Disease, Documentation, Drug Development, Due Diligence, Equal Employment Opportunity (EEO), FDA (Food and Drug Administration), GCP (Good Clinical Practices), Genetics, Interpersonal Skills, Maintain Compliance, Medical Conditions, Medical Records, Microsoft Excel, Microsoft Word, Military, Multitasking, Negotiation Skills, Neurology, New Drug Application, Operations Management, Operations Processes, Organizational Development/Management, Organizational Skills, Policy Development, Policy Implementation, Presentation/Verbal Skills, Process Management, Project Planning, Project/Program Management, Quality Metrics, Regulations, Relationship Management, Resource Management, Risk Analysis, Risk Management, Software Administration, Standard Operating Procedures (SOP), State Laws and Regulations, Stock Purchase Plans, Support Documentation, Team Lead/Manager, Tuition Fees, Vision Plan, Willing to Travel, Writing Skills

LOCATION

Princeton, NJ

POSTED

30+ days ago

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 Princeton, NJ, OR San Diego, CA, OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThis role is responsible for supporting Clinical Operations' management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA's and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.Primary Responsibilities* Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.* Ensures quality delivery of study enrollment within agreed budgets and timelines.* Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.* Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.* Effectively communicates project status and issues to management and the team.* Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.* Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.* Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.* Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.* Oversees clinical study budgets.* Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.* Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.* Recommends and implements innovative process ideas to positively impact clinical trials management.* Other responsibilities as assigned.Education/Experience/SkillsBachelor's degree in life sciences or related field. Targeting 8 years' progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.Key Skills:* Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.* Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).* Demonstrated ability to successfully develop, implement, and manage clinical trials.* Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.* Demonstrated technical, administrative, and project management capabilities.* Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills.* Proficient computer skills, including Microsoft Word and Excel.* Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.* Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.* Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.* Must be willing and able to travel both domestically and internationally.#LI-HYBRID #LI-CA1In 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$147,900—$184,900 USDWhat 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 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.ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

About the Company

ACADIA PHARMACEUTICALS INC

Resume Resources

Free Resume Templates Free Resume Builder