- Sets the strategic direction for CRO, central lab and preferred clinical trial vendor providers used in support of all clinical trials supported by Clinical Operations
- Leads the develop robust vendor performance and governance programs, including establishment of key performance indicators, key risk indicators and effective vendor oversight to provide global, high quality clinical trial services; ensures CRO/vendors alignment with relevant Acadia corporate goals and drives operational efficiencies
- Develops preferred CRO and vendor partnerships and maintains relationships with external providers
- Leads governance forum (Executive Steering Committees, Joint Operating Committees etc.) across clinical trial vendor relationships (CRO, central lab and other key clinical trial vendors)
- Accountable for CRO, central lab, key clinical trial vendor provider performance; ensures clear focus and understanding of all issues surrounding performance
- Responsible to ensures support received from CRO, central lab, key clinical trial vendor provider is industry leading in cost, speed, and quality. and provides value for the company through increased savings and efficiencies.
- Provide expert insight and knowledge regarding rates, unit costs, and costing structures to enable optimal negotiations with study vendors, with emphasis on vendor performance, financial risk management, and compliance requirements
- Leads ongoing review of external CRO and key clinical trial vendor environment and performance metrics benchmarking
- Oversee vendor contracting, in partnership with Clinical Operations study teams, Procurement, Legal and Finance, overseeing Master Service Agreements, Work Orders and Change Orders
- Serve as an escalation point for CRO and key vendor relationships; address and/or escalate vendor performance issues; identifies probable vendor risks and potential mitigation strategies
- Leads financial and resourcing demand forecast planning and management for Clinical Operations
- Partners with study teams to ensure appropriate tracking of all study budgets, accruals, projections, invoices, etc.
- Reviews operational budgets quarterly to ensure adherence to projections; monitors and optimizes operational costs and trial resourcing while maintaining high-quality standards
- Serves as strategic thought partner and drives efforts and strategic initiatives; works closely with the leadership team to lead, develop, and implement critical cross-functional initiatives and organizational change workstreams
- Provide overarching strategic direction for the implementation of Diversity, Equity, and Inclusion (DEI) initiatives within the Clinical Operations group
- Foster a culture of collaboration, inclusion, and diversity advocacy, working closely with cross-functional teams and stakeholders
- Oversee the development and implementation of DEI policies and procedures within Clinical Operations, ensuring alignment with organizational goals
- Establish and monitor key metrics to assess the effectiveness of DEI initiatives, providing regular reports to leadership and identifying areas for improvement
- Cultivate external partnerships and collaborations that align with DEI goals, promoting the organization's commitment to diversity in the clinical research landscape
- Engage in ongoing evaluation and refinement of DEI strategies, staying informed about industry best practices and evolving standards to continuously enhance the organization's commitment to diversity, equity, and inclusion
- Extensive financial experience, including direct oversight of clinical trial and department level budgets, tracking and reporting
- Clinical trial costing and resource benchmarking and forecasting experience
- Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
- Demonstrated ability to deliver results and achieve objectives within budget and timeline constraints. Proven experience in cost optimization and reduction
- Significant experience in pharmaceutical/biotechnology and extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical trials
- Comfortable working with Senior Executive Teams
- Well networked with industry peers
- Strong project management skills and effective matrix leader. Able to hold teams accountable to deliverables
- Ability to travel up to 20%
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Senior Director, Clinical Vendor Management and Operations - Princeton, United States - ACADIA Pharmaceuticals Inc.
Description
Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.The Sr.
Director, Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering clinical trial services to the Clinical Operations organization.
As a member of the Clinical Operations Leadership Team, the Sr.Director develops and leads Contract Research Organizations (CRO), Flexible Service Providers (FSP), vendor and DEI strategies for Clinical Operations and is accountable for Business Operations, Systems & Metrics, as well as oversight of the FSP.
The Sr.Director will lead a specialized team of individuals and be accountable for > $100M in contract value in support of all clinical trials in the Development portfolio.
Primary ResponsibilitiesVendor Management
MSc, MBA, PhD or equivalent or related field.
Targeting 12 years within the pharmaceutical industry with Clinical Operations experience, including global experience and 8 years of leadership experience building strong technical & operations-based teams with business acumen, consultative skills, results orientation and influencing capabilities.
An equivalent combination of relevant education and experience may be considered.Key Skills:
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.
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