Director Clinical Operations Rare Disease
About Acadia Pharmaceuticals
Position Summary
This role will be a highly qualified and motivated individual who will have a leadership role in the department. This person will have extensive leadership and management experience, including demonstrable expertise in the successful planning and execution of clinical development plans and studies. The role will provide leadership and expertise in the global operational strategy and directing project teams to support clinical study planning and execution.
Primary Responsibilities
- Responsible for the development and management of all operational timelines and budget for programs under the respective therapeutic area
- Responsible for providing operational input for development plans in support of the asset strategy
- Represent the respective therapeutic area for senior management as needed
- Leads the strategy and tactics to successfully work with vendors, investigators, other departments within ACADIA, and the program clinicians to develop, execute and deliver clinical programs supporting drug development while ensuring quality speed, budget, and regulatory compliance
- Evaluates, refines, and makes recommendations for various operational constructs for study execution
- Leads and shares best practices with internal and external stakeholders, as appropriate
- Establishes performance, quality, business efficiency and innovation metrics for clinical teams; addresses systematic deficiencies and seeks to improve quality across study programs
- Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs
- Provides direction in the development and oversight of study plans to ensure quality processes are followed
- Responsible for direct management of Clinical Operations team members in the respective therapeutic area to ensure consistent application of best practice and execution
- Supports mentoring and training of Clinical Operations staff in the respective therapeutic area
- Participates in and/or leads process improvements within/between cross functional areas to increase efficiencies and manage costs
- Develops and measures appropriate metrics to assess and improve vendor and site performance
- Ensures that cross-functional process efficiencies are identified and maximized in accordance with project goals
- Oversees and is accountable for appropriate resource planning to support specific therapeutic area
- Participates in the selection, management and oversight of CROs and other vendors, driving quality performance to milestones and deliverables
- Other responsibilities as required
Education/Experience/Skills
Bachelor’s degree in the life sciences or related field; Advanced degree preferred. Targeting 10 years’ clinical development and management experience, with significant clinical trials experience and 8 years’ proven experience in a leadership and people management role. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Experience leading and managing complex global clinical development programs is required
- Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization
- Demonstrated track record of translating senior level research/scientific business requirements into operational strategies globally
- Has broad experience selecting, managing, troubleshooting and negotiating with CROs and other vendors
- 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
- Demonstrated technical, administrative, and project management capabilities
- Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals
- Demonstrated analytical abilities and proficient planning and negotiation skills
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
- Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output
- Ability to travel 25% of the time
Physical Requirements
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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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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.
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 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 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.
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Join us at Acadia Pharmaceuticals as the Director of Clinical Operations for Rare Disease, where you will embark on a mission to revolutionize neuroscience. We pride ourselves on developing innovative treatments that elevate lives, like the first FDA-approved drug to tackle hallucinations associated with Parkinson's disease and the only approved drug for Rett syndrome in the U.S. and Canada. In this dynamic role, you'll be at the forefront of global operational strategy, leading your colleagues in planning and executing clinical study programs. As an expert with a rich background in clinical development, you'll manage timelines, budgets, and vendor relationships while ensuring that all studies adhere to the highest standards of quality and regulatory compliance. Your influence will extend throughout the organization, as you mentor clinical operations staff and collaborate with various departments to ensure seamless execution. With your leadership, the team will strive for excellence and innovation in drug development tailored to neuro-psychiatric and rare diseases. We value diverse perspectives and are excited to welcome the best talent, so if you're passionate about making a difference in healthcare, this opportunity is for you!
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