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Director, Business Operations Analyst Lead
Clinical Data Science Overview
Clinical Data Science (CDS) is a business unit within Development whose mission is to achieve regulatory approval and successful marketing of new therapies through a reproducible, transparent, efficient, and validated approach to study design, data acquisition, analysis and interpretation. Our pursuit is to deliver on unmet medical needs by introducing therapies for life-threatening diseases. Within CDS we strive to reach this goal through excellence in data management, analytical methods, and developing advanced programmatic approaches to gain insights from a wide range of data assets.
The Director of Business Operations will be member of the Business Operations and Strategic Function, accountable for developing new frameworks, optimized operating models & processes, and tools to deliver operational excellence within CDS. The position will be directly involved in supporting continuous improvement projects centered on goals to improve operational productivity, achieve high quality oversight, and develop foundational capabilities to meet diverse Therapeutic Area demands and scale staffing models effectively.
The Director, Business Operations Analyst Lead will work closely with the Head of CDS Business Operations and Strategic Initiatives & CDS Leadership on various business cases and project-based work, requiring the individual to leverage their advanced analytical skills and superior knowledge in value chain management within the field of data science to detect areas of opportunity or resolution. To that end, the position will require a strong technical understanding in how to solve business problems by using data driven approaches to examine options that will minimize bottlenecks, simplify processes, and mitigate quality errors.
The individual will need to apply critical-thought and conduct assessments to propose solutions and value-based options in areas such as: identifying areas for innovation and automation though a centralized CDS innovation panel, staff sourcing models, development of precise role-based resource algorithms for adoption and utilization in Planisware, and performance oversight including accountability for the creation and maintenance of functional metrics. In addition to performance, the role will be responsible for supporting CDS functional teams on quality management, specifically as it relates to vendor services. The individual will work closely with teams to refine quality measures and develop procedural plans that define operational oversight in error detection, service level agreements/Key Compliance & Performance indicator, and task management.
Key Responsibilities will include, but are not limited to the following:
- Champion change through strong leadership in taking projects from ideation stage to full production deployment.
- Leverage statistical models and/ or resources to produce evidence in how a particular practice, process, or data flow may be improved within a particular area of interest or directed by a business goal.
- Spearhead innovative solutions, which will automate tasks aimed to increase throughput and/or reduce cycle time. Be an active voice on the newly formed CDS innovation panel to help lead high risk-reward solutions based on a fixed CDS innovation budget.
- Be a leader in performance oversight through the defining precise metrics from valid sources that will allow leadership to detect quality or performance issues, perform trend analysis, as well as highlight areas which are below industry averages/medians.
- The position will be accountable for the creation and maintenance of a new CDS performance metric dashboard: SONAR.
- Work closely with CDS extended leadership members on resource model changes (internal vs offshore), to ensure the change is embedded and monitored correctly post implementation.
- Support the transition to Planisware through leading efforts that help define resource forecasts and predictions as well as compare actual supply and demand volumes.
- Examine mathematical work-unit based models to support future-state resource algorithms.
- Identify major tasks and activities which aggregate to highest time commitments across trial periods, phases, and TAs for each CDS role.
- Support the initiative to translate departmental resource algorithms to precise role-based models.
- Partner closely with CDS LT and their management teams to develop robust quality oversight and management of vendor services.
- Help to develop random sampling techniques which monitor quality and completeness of assigned deliverables.
- Review and author quality oversight plans with LT members that define practices related to quality assurance.
- Participate in annual goal reporting activities, such as defining measurement that allow CDS to track progress against goal targets.
- PharmD/PhD with 8+ years' relevant experience.
- MA/MS/MBA with 10+ years' relevant experience.
- BA/BS with 12+ years' relevant experience.
- Applicant needs to have at least 10 years working within Clinical Development, clinical trial operations, or similar experience in healthcare institution(s).
- Ability to problem-solve using data-driven approaches to help determine the best path forward.
- Passionate about continuous improvement and establishing new procedures which embrace technological solutions and/or automation via advanced programmatic solutions (i.e. Robotics Processing Automation).
- Ability to lead through ambiguity when path to end result may not be straight-forward and known, whereby research and critical stepwise thought is essential to delivery of anticipated outcomes.
- Strong project management expertise able to support teams through bottlenecks and areas of resource impact.
- Experience leading complex changes, which require in-depth change management and transition plans
- Experience in working through organization and resource model changes (e.g., transition to outsourcing, augmented workforce, function service providers, etc....)
- Ability to motivate large diverse teams to achieve a common set of goals.
- Strong experience in data analysis and demonstrated critical thinking skills
- Proven effective verbal, written, interpersonal skills to include delivering presentations to executives
- Excellent organizational and project management skills
- Able to lead and mentor effective cross functional teams
Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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