Director, Clinical Contracting & Budgets - On-site/Hybrid
Boehringer Ingelheim
- Ridgefield, CT
- Contract
- Full-time
- Provides leadership and strategic direction to the Clinical Contracting & Budget and Site Payments group.
- Oversees completion of clinical site contract & budget negotiations.
- Accountable for the direction, oversight and delivery of contract lifecycle management, including site budgets, CDA/CTA contract development and negotiations; the coordination, processing, monitoring, and administration of payments in accordance with those Contracts and Budget Exhibits; setting guidelines in developing negotiation strategies and providing oversight for all negotiations.
- Develops and implements contracting-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables.
- Develops and implements budget-specific, payment-specific, and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables.
- Steers the team delivery of pipeline commitments, effective leadership and best practice, leveraging data & technology, and customer engagement approaches that maximizes value for patients.
- Establishes evaluation tools and monitor multiple CRO/third party vendor performance to address performance issues and ensure deliverables are of high-quality standards and within planned timelines against contracted scope of work (SoW).
- Ensures team members are aware of their accountabilities, responsibilities, and deliverables. Ensure optimal planning, oversight, resourcing, execution, and delivery of clinical trials.
- Accountable for the oversight and strategic direction of employee and in-sourced resources (supporting contracting and department tasks): onboarding, performance tracking of any external resources, developing and ensuring consistent adherence to agreed study team setup inclusive of the division of tasks between Contract and Budget Managers.
- Develops and implements Clinical Contracting specific, and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables in site contracting space inclusive of budgets & Site Payments. Oversight of centrally accessible dashboard of clinical contracting priorities.
- Develops and maintains a close working relationship with Study Management & Conduct, Site Monitoring, Training & Compliance, ClinOps Business Operations, Site Feasibility and Patient R&R, Legal, Ethics & Compliance, Clinical Development & Medical Affairs (CDMA), Translational Medicine, Finance, and Global Sourcing Departments to assure a closely coordinated program of activities based on common objectives and focusing on value, quality and operational efficiencies.
- Partners with Legal Operations to provide strategic recommendations relating risk management/mitigation based on data review and analysis, understanding the trade-off between risk and speed; support review process to address and propose changes to standard contract template language within guidelines.
- Acts as primary point of contact for Legal Operations in the Clinical Contracting Space.
- Partners with Global Sourcing for vendor needs, contract work force, including SOW creation, project management of timelines.
- Supports Executive Director in management of annual budget and quarterly forecasting for cost center. Monitor expenditure of budgeted funds, when possible, build in cost efficiencies and provide justification of variances.
- Monitors and approves service provider and independent contractor invoices.
- Leads and/or represents Contracting and Budget group for international and interdisciplinary projects and working groups.
- Standardizes best practices and create action plans to achieve integration and alignment.
- Provides visibility to trial teams and broader CD&O organization via presentation of risks/trends and project status/deliverables and/or mitigation strategies.
- Synthesizes information and feedback from stakeholders to ensure a high degree of responsiveness to both internal and external customers.
- Resolve issues by working collaboratively across CD&O and other groups within BI.
- Liaises with key partners, i.e., legal to support issue resolution.
- Identifies areas of opportunity for excellence and growth in the spirit of continuous improvement to promote successful study milestone deliverables.
- Aligns with CD&O stakeholders to ensure strategy and approach for clinical trials is appropriate to meet study timelines (particularly startup) while communicating with all internal and external stakeholders as applicable.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
- Bachelor's degree required plus a minimum of ten (10) years' experience in clinical research with a minimum of six (6) years in the regulated Pharmaceutical industry; Master's or Advanced degree such as JD preferred.
- Demonstrated experience leading/managing teams and organizations; direct management experience preferred.
- Demonstrated direct experience in the authoring, negotiation and management of Site/Trial Contracts.
- Demonstrated direct experience in the development of Trial Budgets.
- Extensive working knowledge and experience in contract environment, contract negotiation and or/clinical finance and /or clinical vendor management.
- Extensive knowledge and experience of outsourcing practices, managing clinical vendors and or Contract Research Organization performance required.
- Track record in setting priorities, organization and problem-solving skills which support and enable sound decision making.
- Excellent customer service skills and high attention to detail.
- Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.
- Experience leading and managing teams/organizations.
- Ability to lead with vision and to develop a high performing team.
- Experience initiating and lead department and cross-functional strategic initiatives.
- Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.
- Ability to use and learn system applications, e.g., MS Office, document management systems, etc.
- Demonstrated experience in the areas of clinical trial conduct (including protocol development, implementation, monitoring, safety surveillance, code of federal regulations, ICH/GCP, etc.
- Demonstrated experience in the regulated pharmaceutical or healthcare industry.
- Thorough understanding of all phases of drug development (I-IV).
- Demonstrated experience in the conduct of large scale multinational clinical trials.
- Understanding of federal regulations pertaining to IND and NDA regulations.
- Ability and willingness to travel domestically and internationally (10-20% of time).
- The North Star Provider: Leading matrixed internal teams (ability to influence without authority), proven managerial skills.
- Develops and empowers individuals & builds effective teams.
- Ability to actively engage with customers, building strong customer relationships and delivering customer-centric solutions.
- Ability to effectively build and manage relationships with different stakeholders internally and externally, engaging with them in a planned and meaningful way in pursuit of the company's strategic objectives and feeding intelligence back to the company to maximize the deliverables.
- Ability to have a positive impact on others, to persuade or convince them to gain their support.
- Ability to develop and maintain relations, alliances and coalitions within and outside the organization and to use them to obtain information, support and cooperation.
- Ability and a strong desire to know or learn something, inquisitiveness, interest, curiousness.
- Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
- Adherence to the standards, values and rules of conduct associated with one's position and the culture in which one operates.
- Pro-active and agility to take direct action courageously to attain or exceed objectives.