Director, Clinical Contracting & Budgets - On-site/Hybrid

Boehringer Ingelheim

  • Ridgefield, CT
  • Contract
  • Full-time
  • 17 days ago
DescriptionThis role is considered an on-site/hybrid role meaning it is expected to work from the Ridgefield, Connecticut office 2-3 times per week.The Director, Clinical Contracting & Budgets will support the Executive Director, US Site Management & Monitoring group within US Clinical Development & Operations (CD&O) to implement the strategic direction, oversight and management of the Clinical Contracting & Budgets groups and ensures the management goals and objectives of the department are met effectively and efficiently. This role is accountable for end-to-end Clinical Contracting, including resource forecasting, on-boarding, and performance tracking for staff across all US clinical programs. The incumbent collaborates with internal stakeholders to support the allocation of resources and coordination of all staffing decisions.The Director, Clinical Contracting & Budgets supports the Executive Director, Site Management and Monitoring to lead the Clinical Contracting group responsible for developing and maintaining a group which executes site contract negotiations and budgets, relevant for but not limited to payments, negotiating and executing budgets and contracts (inclusive of Master Service Agreements, Rate Cards and Disclosure Agreements). This position is responsible for providing the strategic direction, oversight and management of the Contracting and Budget and Site Payments group to ensure that management goals and objectives of the department are met. The incumbent is accountable for the US site CDA/CTA contract negotiations; for ensuring high quality Clinical Trial Investigator budgets are established within fair market value process; timely and accurate payments to sites based on agreed-upon budgets and terms all in support of US clinical programs across multiple therapeutic areas.The CD&O line manager is responsible for providing strong leadership that is aligned to the HPBU intent, Medicine and CD&O vision, strategies, goals, and operating model to ensure successful delivery (speed & value) of clinical trials in the team. The line manager is responsible for the execution, delivery and oversight of high-quality clinical trials that meet pipeline commitments, specific scientific medical, and regulatory requirements in the team. This role is responsible for team performance oversight and excellence. The incumbent embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk talking and one common CD&O identity.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities
  • 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.
Additional Duties & Responsibilities
  • 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.
Eligibility Requirements:
  • 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.
Requirements
  • 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.
CompensationThis position offers a base salary typically between $167,000 and $289,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please

Boehringer Ingelheim