Senior Manager II AT Foster City, California II (PMP/BA/clinical) II (Gilead) II JL

Senior Manager, Development Finance, Development Business Operations
This key role is responsible for the development, refinement, forecast, and administration of external Development spend in support of Phase I through IV clinical trials. Total external clinical trial spend is $1B+ over 200+ active clinical trials annually. This position will lead financial activities for one or more development programs. The position involves strategy, planning, oversight, and delivery of Budget Administration across the clinical drug development cycle. The successful candidate will have deep expertise in global program design, people management and development, direct vendor interaction, an understanding of accrual methodology, and generation of accurate and detailed clinical trial budgets to include CRO, Central Lab, auxiliary lab, Investigator Fees, comparator drug and other peripheral vendors. Budget Development includes skills to understand cost drivers and ability to generate total estimated budgets as well as model scenarios and forecast spend over time. Project management skills in the biotech or pharmaceutical industries with a strong foundation in operations, finance, budgeting, modelling, executive presentation and superb stakeholder management skills are critical for success in this role. Ideal candidate will have demonstrated success in working in a matrix environment and collaboratively with stakeholders
This position will be located at Gilead’s Headquarters in Foster City, CA.
The core responsibilities and skills required for this position include but is not limited to:
Delivery Excellence
• Provide guidance and training to more junior members of the department. Position may include assignment of direct reports.
• Manages all financial aspects of external clinical spend for Gilead clinical trials for assigned programs.
• Responsibilities include management of accrual, purchase order/invoice, and latest estimate processes and development of site budget and study budget scenarios to support governance & planning, and compliant payments to external vendors and Investigative Sites participating in Gilead trials
• Collaborates with Development Operations, Corporate Accounting, FP&A and P2P teams, Clinical Operations, Clinical Systems, Clinical Data Management, and Investigative Sites and external vendors to ensure financial reporting accuracy, timely and accurate issuance of payments, extensive contract and payment administration support, and compliance adherence
• Responsible for development of accurate budget estimates and forecasting for external clinical trial expense, meeting Gilead Controller’s Manual, Open Payments Transparency Act and SOX for calculation of vendor earned amounts for financial accrual, and compliant payments to external vendors and Investigative Sites participating in Gilead trials
• Collaborates with study teams to understand study scope to effectively forecast clinical spend, validate vendor and site activities for payment and accrual purposes, as well as with Financial Shared Services, Clinical Systems and Gilead IT to manage effective and accurate calculation and issue of payments to investigators
• Demonstrates understanding of accounting and finance practices pertinent to clinical development.
• Provides input to strategy for and supports development of detailed estimates of external Clinical Trial Costs to include CRO, Site Sites, Central & Speciality Labs, Imaging, comparator drug, etc.
• Strong understanding of clinical cost drivers and ability to forecast clinical spend over study life cycle required. Ability to model different assumption scenarios and provide guidance to teams regarding material cost drivers and potential design inefficiencies.
• Leads the escalations related to potential budget variance terms of risk management, leading issue resolution at the operational and senior executive levels.
• Works collaboratively with operational teams, vendors, accounting, SOX and FP&A to develop and implement best practice solutions and methods for clinical trial cost accruals.
• Trains staff in trial budgeting, forecasting, accruals and study reconciliation.
• Develops appropriate job aides and tracking tools.
• Manages budget activities for multiple clinical development programs, ensuring that there is adequate staff with the skills to complete contracts accurately, consistently, and in a timely manner.
• Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research – Good Clinical Practices (GCPs)
• Delivers with optimal collaboration, accountability, and integrity to business partners
Strategic Thinking
• Shows the clear ability to apply critical thinking, strategy development, and vision towards the growth of stakeholder relationships, while also overseeing the day-to-day execution in a high volume, fast paced environment.
• Participates and supports development and implementation of departmental and cross-functional policies and procedures.
• Translates the usage of industry best practices to the overall program, utilizing external sources such as benchmarking, data, and processes to continually provide input and drive improvements linked to an overall strategy.
Innovation
• Leverages prior experience with external benchmarking, industry best practices, and technology to continuously improve budgeting, forecasting, and accrual practices.
• Supports the functional evaluation of new business processes or process improvement opportunities
Influence and Partnership
• Shows clear ability to work collaboratively with other cross functional groups and with vendors.
• Exhibits competency in regularly establishing relationships with cross functional teams, such as operations, finance, quality, systems and process, as well as externally with the corresponding vendor functions
• Demonstrates collaboration and drive for global standardization and best practices with internal and external business partners to deliver greater operational performance, efficiency, and quality.
• Is able to clearly and succinctly present to executive leadership with sound judgement and agile response.
People Development
• Exhibits strong mentoring skills and potential for line management
Decision Making
• Demonstrated ability to make critical decisions related to projects and tasks
Communication
• Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with senior executives
• Successfully translates the organizational focus and strategic objectives between organizations (internal and to the managed vendor base), and subsequent management or participation on teams for implementation activities and/or change management
Capabilities and Requirements
• Prior role or experience serving as a manager to support organizational decision making or strategic planning in a data driven manner
• Relevant experience typically includes clinical trial cost negotiation or estimation, familiarity with clinical trial contract and payment structures, exposure and/or expertise in accounting practices and financial reporting.
• Experience with supporting the implementation of an EBS systems a plus
• Experience with PMP or CPSM certification a plus
• Demonstrated leadership skills while working in fast paced and changing environment
Knowledge, Experience and Skills:
• 6 years of experience with a BA in a relevant discipline.
• 4 years of experience with a MS in a relevant discipline.
• Line management experience
• MBA or Master of Accounting preferred
• Superior computer skills (Microsoft Office including Excel, Word and PowerPoint)
• Skilled at development and delivering staff training
o Relevant experience typically includes budget development, CRO or site contract development and negotiation (FMV), clinical development, or corporate finance within pharma industry.
o Familiarity with operational tools such as six-sigma, lean, and process mapping a plus
o Advanced certification (PMP, etc.) a plus