Executive Director, Data Management
San Diego, CA - USA
Job Summary
Please note that this position can be based in San Diego CA; Princeton NJ; San Francisco CA. Acadias hybrid model requires this role to work in our office an average of 3 days per week.
Position Summary
The Exec. Director Data Management is a key leadership role within Acadias R&D organization responsible for driving strategy operational excellence and continuous improvement across the Data Management function. This individual will lead the design implementation and oversight of clinical data collection and database review activities that support critical development programs and company objectives.
Working closely with cross-functional leaders the Exec. Director will advance efficient high-quality data management processes ensure systems are business-ready and lead data management outsourcing and vendor/FSP partnerships. This is an exciting opportunity to shape data strategy and make a meaningful impact on the development of therapies for patients with unmet medical needs.
Primary Responsibilities
- Provide strategic leadership and oversight of Data Management activities across Acadias clinical development portfolio
- Lead and develop the Data Management function including organizational design resource planning budgeting hiring and performance management
- Establish and evolve a scalable Data Management operating model that leverages both internal capabilities and outsourced vendor/FSP partnerships
- Oversee vendor selection governance contract management and performance to ensure high-quality data management deliverables
- Drive the development and implementation of Data Management standards processes SOPs and inspection-readiness practices
- Ensure the timely delivery of high-quality clinical databases and datasets supporting analysis regulatory submissions and health authority inspections
- Provide strategic oversight of clinical data management systems technologies and data standards to support business and development objectives
- Identify operational risks and lead process improvement initiatives to enhance efficiency quality and business continuity
- Serve as the Data Management subject matter expert during audits inspections and cross-functional governance activities
- Other responsibilities as assigned
Education/Experience/Skills
- Bachelors degree in the scientific biological statistical or computer science field or related discipline; advanced degree strongly preferred. An equivalent combination of relevant education and experience may be considered.
- Targeting 15 years of experience in the pharma/biotech industry including 10 years direct report or vendor management experience
- Experience managing multiple direct reports contingent workers and programs including resource planning for Data Management functions workforce infrastructure and clinical study deliverables
- Self-directed technically strong and a recognized leader maintaining a strategic prospective regarding data management processes management of DM activities and customer management
- Experience working within both in-house and outsourced Data Management operating models
- Vendor evaluation selection governance and management experience including oversight of Data Management activities outsourced to CROs FSPs and other vendors
- Experience leading organizational change and driving process improvements within a Data Management function
- Strong understanding of clinical trials pharmaceutical operations regulatory compliance FDA regulations and ICH guidelines related to data integrity
- Ability to manage timelines incomplete information and unexpected events while maintaining accuracy and operational excellence
- Demonstrated ability to influence and communicate effectively across all levels of the organization including executive leadership and build strong working relationships across teams
- Must be willing and able to travel both domestically and internationally as needed
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.
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Required Experience:
Director
About Company
For 30 years, Acadia has been working at the forefront of healthcare to protect what makes you, uniquely you. This is our purpose.