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Director Clinical Operational Excellence

Director Clinical Operational Excellence

New Jersey StaffingPrinceton, NJ, US
15 days ago
Job type
  • Full-time
Job description

Director Of Clinical Operational Excellence

Acadia Pharmaceuticals 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.

This position is based in either San Diego, 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 Operational Excellence will lead strategic initiatives that optimize and standardize clinical operations across global programs. This role is responsible for driving continuous improvement, ensuring regulatory compliance, and fostering a culture of quality and efficiency. Partnering cross-functionally and with Clinical Service Providers, the Director will design and implement process improvements, oversee training and SOP management, and apply data-driven insights to enhance clinical trial execution. This is a key leadership position that will directly influence how Acadia delivers high-quality, compliant, and patient-focused clinical trials.

Primary Responsibilities

Operational Excellence & Process Improvement

  • Develop, lead, and implement process optimization strategies for clinical operations to enhance efficiency, reduce costs, and ensure regulatory compliance through strategic leadership, process management, and change enablement.
  • Lead Clinical Operations strategic planning sessions to align process improvement goals with long-term business objectives.
  • Establish mechanisms to identify, prioritize, and resolve process issues / gaps within Clinical Operations; work to prioritize and implement process improvements, where required, through collaborative problem solving and effective communication.
  • Identify opportunities for improvement within existing operational processes and lead the implementation of continuous improvement programs, applying methodologies such as Lean Six Sigma, to drive measurable outcomes.
  • Track and report performance metrics to demonstrate impact of improvements.

Process Management and Training Oversight

  • Lead the production and reporting of operational excellence metrics to the Clinical Operations Leadership Team and key internal stakeholders, driving decisions based on data and analysis.
  • Ensure GCP compliance and data integrity through data-driven insights.
  • Oversee creation, maintenance, and obsolescence of Clinical SOP / WI / Forms / Templates; direct work related to new process creation, training, and rollout.
  • Manage QMS CAPAs, Deviations, and Document Change Controls (DCCs); support and manage audit findings and resolutions.
  • Monitor Clinical Operations training compliance; manage processes for ensuring that clinical operations and related CSPs using ACADIA processes are current with training and training documentation; may conduct training for small groups and participate in training sessions for CSPs.
  • Manage the Clinical Operations Training Curricula; work with Quality to align curricula assignments with applicable SOPs and ensure standardization across functions.
  • Serve as SME on regulatory requirements and industry best practices related to Clinical Operations processes and training compliance.
  • Collaborate with cross-functional teams to address training gaps and develop training materials as needed. Lead and conduct training sessions.
  • Drive change management initiatives to support adoption of new processes and systems. Promote a culture of continuous improvement and quality mindset across Clinical Operations.
  • Cross-Functional Collaboration

  • Partner collaboratively with colleagues and leadership team to implement cross-functional initiatives that promote operational efficiency and drive clinical trial success.
  • Collaborate with internal and external stakeholders, including Clinical Operations teams and external vendors, to streamline workflows and ensure alignment with best practices.
  • Develop communication strategies to ensure transparency and alignment across functions. Facilitate workshops and forums to gather feedback and foster collaboration.
  • Other duties as required.
  • Education / Experience / Skills

    Bachelor's degree in Life Sciences, Business, Engineering, or a related field; Master's degree preferred. Targeting 10 years of relevant progressive experience in clinical operations, with a focus on operational excellence and process improvement. An equivalent combination of relevant education and experience may be considered.

    Key Skills :

  • Demonstrated experience in leading process optimization initiatives and driving operational efficiencies in a global clinical trial setting.
  • Strong clinical operations and project management skills with expertise in process improvement methodologies (e.g., Lean, Six Sigma).
  • Previous management experience with demonstrated leadership capabilities.
  • Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external vendors.
  • Proficiency in clinical operations systems and tools such as Clinical Trial Management Systems (CTMS), eTMF, Veeva Vault platforms (Quality Docs, Clinical, Safety, RIM, Change Control, CAPA, Audits, Complaints, Quality Risk Management (QRM), Supplier Management) and related platforms.
  • 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.

    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 $191,000$238,800 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.

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