Associate Director Clinical Operations
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
This person will be supporting Clinical Operations’ management objectives to perform high-quality clinical trials, 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 also serves as key contact and resource for Clinical Study Managers, CRA and CTAs. Responsible for ensuring that clinical studies are effectively carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-departmentally ensuring the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.
- Runs 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, implement, and deliver clinical studies/programs that are of high quality.
- Ensures quality delivery of study enrollment within agreed budgets and timelines.
- This person participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.
- Develops and maintains the relationship 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 in audit reviews.
- Efficiently communicates project status and issues to management and the team.
- Prepares/coordinates 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.
- If a CRO is engaged, handles and reviews the work on an ongoing basis 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 the course of a trial.
- 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 trial management.
- Other projects as assigned.
- Bachelor’s degree in the life sciences or related field. An equivalent combination of relevant education and applicable job experience may be considered.
- Desired 8 years’ dynamically responsible pharmaceutical experience with a focus on clinical trials and late phase development. A minimum of 4 years’ experience in a leadership role. CNS therapeutic experience preferred.
- Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.
- Experience developing clinical protocols, SOPs, 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.
- Managerial courage (ability to be open, honest, and transparent when communicating with all levels of management.
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
- Experience running staff as well as mentoring and developing junior staff.
- Adaptable to changing priorities and ambiguous environment.
- Proficient computer skills, including Microsoft Word and Excel.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.
- Adept at crafting and communicating a clear vision among team members efficiently aligning resources to achieve functional area goals.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 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
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.