Budget and Contract Outsourcing Manager
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR- mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
- Responsible for outsourcing and contracting services provided throughout Clinical Development
- Provides expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials
- Support the identification, selection and management of global external service providers.
- Oversees and maintains the relationship with contract research organizations and other third party service providers.
- Evaluates and analyzes tools and processes to support outsourcing efforts.
- Manages 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 reconciliates the invoicing with contracts and budget, to control actual expenditures vs. budget for all major clinical contracts.
- Ensures 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 and are consistent with approved budgets and forecasts for each respective program.
- Evaluates and actively manages vendor performance against agreed upon expectations.
- Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Assist in development and implementation of 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 R&D objectives.
- Partner with colleagues in clinical development, finance and legal department and perform the analysis of actual clinical study spend, calculation of appropriate clinical study accruals, to ensure the team is using consistent and efficient business processes and tools for outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls.
- Provide 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; assisting Finance team in setting up and processing POs and providing insightful analyses used to improve future planning.
- Collaborate with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors.
- Assists clinical development team in the selection of qualified providers that complement Drug Development’s strategic core competencies and allow the team to focus on internal operational excellence while relying on external providers for efficient and flexible execution of clinical trials.
- Effectively manage vendor agreements, support the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions.
- Monitor, control, and report performance metrics established for vendors.
- A bachelor’s degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master’s degree is preferred. Equivalent experience may be accepted.
- A minimum of 8 years Pharmaceutical development experience with at least 4 years managing CROs is required.
- Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required.
- Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.
- Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred.
- Previous people management experience is preferred.
- Must have effective problem solving skills