Senior Director Data Management
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
The Sr. Director is a key leadership role in the R&D organization. This individual will provide strategic direction, leadership and management in shaping operational excellence within the Data Management (DM) team. Directs the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives. The Sr. Director will work with leadership across Acadia’s functional areas on the continuous development and improvement of business processes to support Data Management. Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives. Leads outsourcing of data management and management of vendor/FSP alliance.
Primary Responsibilities
- Provide strategic leadership of data management function
- Development of department standards and procedures (e.g., SOPs, job aids)
- Identification and leadership of critical DM process improvement initiatives
- Development and management of department budget, resourcing and contracts
- Identification, evaluation and selection of DM vendors
- Lead vendor qualification and oversight audits as DM SME
- Establishment and management of key vendor partnerships
- Ensure department compliance with regulatory and industry process and quality standards
- Ensure program compliance with regulatory and industry process and quality standards, including representation of function in regulatory inspections
- Proactively identifies potential study or process issues/risks and spearheads solutions
- Reviews/approves study-related documents (e.g., eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines), as applicable
- Direct report management and mentorship, as applicable
- Participates in the selection, training and evaluation of DM personnel (internal and contract) to ensure efficient and effective department function
- Ensures that Clinical Data Management interfaces effectively with other Departments.
- Anticipates new challenges, risks, and needs for Data Management, and proactively mitigates to ensure business continuity and quality
- Identifies and resolved quality issues and mitigates future risk
- Responsible for ensuring data management timelines are met
- Provides strategic input into protocol design focused on data management issues
- Develops standards and process documentation, including SOPs and Work Instructions
Education/Experience/Skills
Bachelor’s degree in the scientific, biological, statistical or computer science field or related discipline; advanced degree strongly preferred. Targeting 12-15 years of experience in the pharma/biotech industry, including 10 years direct report or vendor management experience. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Vendor evaluation, selection and management experience
- Experience in managing multiple direct reports, contingent workers and programs
- Experienced in resource planning
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding data management processes, management of DM activities and customer management
- Experience managing data management activities outsourced to Clinical Research Organizations, Functional Service Providers, and other vendors
- Knowledge of lab/image data and other external data sources
- Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
- Practical knowledge of FDA regulations/ICH guidelines, as related to data integrity
- Ability to manage time demands, incomplete information and unexpected events
- Ability to build and maintain positive relationships with management, peers, and direct reports
- Excellent communication and interpersonal skills
- Strong analytical and problem-solving skills. Attention to detail.
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
#LI-HYBRID #LI-KA1
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.
What we offer you (US-Based Employees):
- 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
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.