Vp, Clinical Vendor Management, Business Operations & Systems

Overview
The Vice President, Clinical Vendor Management, Business Operations & Systems 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 Vice President, Clinical Vendor Management, Business Operations & Systems develops and leads CRO, ARO and vendor strategies for Clinical Operations and is accountable for Business Operations, Systems & Metrics, Trial Master File (TMF), as well as people management.
Reporting to the SVP, Clinical Operations, the Vice President, Clinical Vendor Management, Business Operations & Systems will lead a team of $500M in contract value in support of all clinical trials in the Development portfolio.
Key Responsibilities
Vendor Management

• Sets the strategic direction for CRO, ARO, 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 Alnylam corporate goals and drives operational efficiencies
• Develops preferred CRO, ARO 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, ARO, 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
• Oversees day-to-day Sourcing & Vendor Management activities across all clinical trials, providing proactive, results-oriented and business-based recommendation in the evaluation, selection, engagement, and management of clinical services providers
• Identifies and implement best practices for clinical outsourcing including establishment of forums or processes to ensure efficient review and approval of outsourcing strategies
• Lead the functional evaluation of CRO or key vendor processes or process improvement opportunities
• Provides expertise regarding CROs, specialty vendors, including their leadership, organizational structure, business development strategies, financial health, operating strengths
• Stays up to date with industry trends regarding the new specialty outsourcing services/solutions

Business Operations

• Leads financial and resourcing demand forecast planning and management for Clinical Operations (>$250M; >90 resources yearly)
• Identifies appropriate clinical trial cost and resourcing benchmarks; challenges teams on appropriateness of trial costs and resourcing; ensure focus on appropriate trade-offs
• 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
• Lead and oversee the annual strategic/investment planning, long-range planning, and corporate goal setting for Clinical Operations
• 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
• Optimize leadership team meetings by ensuring agendas advance goals and priorities, with all actions tracked and commitment completed
• Oversees training to support effective financial management processes throughout the Clinical Operations organization

Systems & Metrics

• Accountable for systems & metrics strategy, implementation, and maintenance of Clinical Operations systems (Veeva, CluePoints etc.)
• Leads business implementation and management of Clinical Trial Management System (CTMS)
• Sets and monitors performance indicators and clinical trial cost metrics for the entire clinical trial portfolio; leads development and maintenance of clinical delivery & cost dashboards; responsible for production and reporting of optimal leading indicators/Key Performance Indicators to Clinical Operations Leadership Team and Senior Executive teams
• Tracks corporate and functional goals pertinent to Clinical Operations

TMF

• Accountable for the TMF operations function to support Development; leads records retention management strategy for clinical trial documents
• Accountable for TMF third party vendors and TMF facilities (on-site and off-site)
• Oversees TMF processes, procedures, and Key Performance Indicators for internal team and CROs

Qualifications

• MSc, MBA, PhD or equivalent in relevant discipline strongly preferred
• 20+ years industry experience focused on Clinical Operations, including global experience
• 10+ year team leadership, building strong technical & operations-based teams with business acumen, consultative skills, results orientation and influencing capabilities
• 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 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.
• Experience in TMF operations including with electronic Trial Master File systems (e.g., Veeva) and related technology platforms; proficient knowledge of DIA TMF Reference Model
• 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 30%
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion, and urgency
• Clear alignment with Alnylam Core Values
  • Commitment to People
  • Fiercely Innovative
  • Purposeful Sense of Urgency
  • Open Culture
  • Passion for Excellence

About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.