Director Clinical Operations
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
This person will be supporting the Sr. Director, Clinical Operations in the overall management of the department’s clinical studies including project planning, clinical budgets, resource management and contract research organization management! The Director acts as an integral resource for Clinical Study Managers, and ensures compliance with good clinical practices and regulatory guidelines. Coordinates clinical trials staff and participates in the management of all aspects of the clinical operational plan. Leads the full scope of study and assists with implementation of clinical policies. Acts as a cross functional liaison to ensure study plan aligns with business development strategies
- Participates in developing the strategy and tactics to successfully work with investigators and other roles at medical centers in order to develop, implement and deliver clinical studies/programs supporting drug development with focus on speed, cost and quality.
- Champions, promotes, and speeds development of high-quality, impactful study sites to support clinical trials.
- In collaboration with other leaders, develops and implements an integrated program that serves to connect clinical study execution strategy with high-quality investigational sites ideally suited to collaborate in the design and execution of patient trials.
- Evaluate, refine and make recommendations for various operational constructs for study execution.
- Collaborates with colleagues in other functional areas for the access to and ongoing placement and conduct of studies at clinical sites
- Cultivates a sustained and strong partnership with clinical investigators and institutions passionate about science and clinical excellence
- Leads strategies for direct patient recruitment into assigned clinical trials
- Chips in on the development of and sharing of standard methodologies to other clinical sites and functional lines, as appropriate
- Collaborates where appropriate with Development in identification of study sites with potential value for conduct of late phase trials
- Advises and assists Development colleagues in decision-making around study placement by providing the requisite information to drive informed business decisions
- Collaborates in the establishment of performance, quality, customer service, business efficiency and innovation metrics for the clinical sites; addresses systematic deficiencies and seeks to improve quality in selected investigational sites.
- Develops and implements communication plans for the sites.
- Develops and measures appropriate metrics to assess and improve development processes.
- Ensures that cross-functional process efficiencies are identified and improved in accordance with project goals and that compliance is maintained.
- Other responsibilities as assigned
- Bachelor’s degree in the life sciences or related field is required. Minimum 10 years’ clinical development and management experience, with significant experience in exploratory development.
- Desired 6 years’ shown experience in a leadership and people management role.
- Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions
- Practical experience in clinical trial strategies, methods, and processes; deep knowledge of clinical trial design
- Excellent verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization
- Validated technical, administrative, and project management capabilities.
- Adept at crafting and delivering a clear vision among direct reports, efficiently aligning resources and motivating teams to achieve goals.
- Validated analytical abilities and proficient planning and negotiation skills
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
- Shown success with cross-functional partnership and running multiple assignments with timely and accurate output.
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.