Executive Director, Clinical Business Operations & Outsourcing
Position Overview
Manages all aspects of financial contracting and invoicing process within Clinical Operations and Development functions.
Ensures vendor contracts are created for each clinical program in compliance with policies and procedures. Monitors and collaborates with Clinical Operations managers to control actual expenditures vs. budget for all major clinical contracts. Provides support to Clinical Program management ensuring programs / projects activities are completed within budget constraints. Enables and facilitates cross-functional information exchange to ensure outside suppliers provide value and expected deliverables in each proposal. Develops business systems, processes and procedures that ensure appropriate processes are in place for contract and management of invoicing and payments. Ensures all contracts with outside parties align with program deliverables as approved by senior management and are consistent with approved budgets and forecasts for each respective program. Communicate back to VP of Clinical Operations progress to enable key decisions to be made on outsourcing, finances and management of the budget. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Manage high-level risks by making complex judgments, developing innovative solutions and applying a comprehensive cross-functional and industry understanding.
Develop a Source-to-Pay process that provides consistency and visibility to the methods and strategies used to identify, select, manage, contract and analyze the financial and service provider resources utilized to achieve the development objectives. Establish and communicate strategic goals and objectives set for Clinical Business Operations and Outsourcing, including identification and monitoring of key performance indicators for Company and it's service providers to allow identification of opportunities for continuous improvement.
Provide leadership and guidance to Development Operations staff to ensure they are operating as effective business partners within Company and to external service providers.
Ensure a positive work environment focused on continuous improvement to meet the growing demands of the complex, global pipeline of clinical development activities.
Partner with counterparts in the organization to ensure the team is using consistent and efficient business processes and tools that are compliant with GCP, SOPs, and corporate financial controls.
Development Operations
Assist and support department head in cross-department and cross-enterprise initiatives and efforts. Collaborate across the department to identify opportunities for increased efficiency, optimization of processes and professional development of team members. Promote and support Company's reputation by acting as an ambassador for the organization with other companies, both sponsor and provider organization. Influence external environment through speaking at industry events and participation in advisory boards or other expert roundtables.
Clinical Business Operations
Provide leadership for responsibilities related to providing accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensuring efficient and compliant contracting of providers; validating of monthly expense accruals; and providing insightful analyses used to improve future planning. Collaborate with Legal on continuous improvement of processes and methodology for contracting with all clinical vendors. Works with Finance to manage program operating budgets vs. actual. Works with Development Operations to ensure departmental resources, budgets and are created and monitored appropriately to meet changing company needs. Ensures 3rd party outsourcing contracts & arrangements are aligned with internal requirements. Proactively manage and resolve issues that may impact program timelines with the development team. Provide direction to direct reports and study teams to manage, in collaboration with Finance, a cradle-to-grave process/system for budget and contract planning and management. Manage and develop Clinical Business Operations personnel to support the functions and objectives.
Clinical Outsourcing
Provide leadership for responsibilities related to providing a global marketplace of qualified providers for Company which complements R&D's strategic core competencies and allows the organization to focus on internal operational excellence while relying on external providers for efficient and flexible execution of clinical trials. Apply strategic sourcing methodology to assure attainment of best service and value, and assuring vendor performance against agreed upon expectations. Implement strategic and effective provider relationship management and governance practices with external providers. Maintain and optimize a rigorous and consistent strategy, methodology, and tools (e.g., forms, templates, checklists, etc.) for provider identification, qualification, selection, management and relationship governance, ensuring adherence to global compliance expectations. Establish the global Company Marketplace of providers with qualified vendors and established relationships that will allow Company to realize shortened start-up time and cost savings. Develop sourcing strategies and methodologies to effectively manage vendors, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions. Participate as a key strategic member of governance teams with CROs and other vendors, leading interactions to address issues and strengthen partnerships. Interact with other R&D leaders, relevant Project Team members, and Department Heads to ensure appropriate providers are identified and managed efficiently.
A minimum of a Bachelors degree is required. An advanced degree, such as an MBA is preferred. Equivalent experience may be accepted. A minimum of 15 years of experience in drug development business support including financial planning, contracts, and vendor management. A minimum of 12 + years of management experience. Previous experience with increasing responsibilities in clinical outsourcing and operations required. A solid understanding of clinical trial principles, design, and analysis. Must have broad and deep understanding of Contracts and Outsourcing for Global Clinical Trials, including a basic understanding of legal, regulatory, GCP, and SOX, components of the process. Must have experience in clinical operational planning in areas such as resource and budget forecasting, operational scenario planning and contract management Strategic agility and business acumen. Good understanding of clinical trial management principles and good organizational and interpersonal skills required. Excellent leadership, communication, negotiation and influencing skills, contracting and legal knowledge/experience pertinent to geography, and experience with clinical research / clinical research organizations essential. Strong influence and communication abilities across a diverse culture. Ability to provide direction with cross-functional teams in highly matrixed team environment, interact with a wide variety of internal customers and relate effectively to people at all levels of the organization. Requires in-depth knowledge of the functional area, business strategies, and the company's goals.Must have a proven track record of successfully interacting with both internal and external executive levels. Excellent organizational and project management skills. Express strong leadership cross-enterprise to help advance Company's objectives.
