United States – Remote
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Director, CDS Quality Oversight and Resource Management
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 Quality Oversight and Resource Management will be member of the Business Operations and Strategic Function, leading important resource and quality management initiatives. The position will work closely with biostatisticians and statistical programmers to successfully execute within a global functional service provider (FSP) model. The position in partnership with other CDS functions is accountable to establish controlled procedures, guidance documents and analytical tools that will monitor and enforce quality standards and practices across offshore and outsourced engagements. The role will also be an invaluable resource to support vendor governance discussions and establish strong vendor alliance and partnership within statistical and data management clinical trial delivery tasks.
Job Overview
The Director of Quality Oversight and Resource Management will work closely with the Head of CDS Business Operations and Strategic Initiatives & CDS Extended Leadership in building strong quality oversight measures and procedures. The role will also work closely within the CDS function and Vendor Outsourcing team to monitor vendor performance, including responsible for completing the following tasks: conduct periodic reviews and finalization of vendor oversight plans, quality agreements, and assist CDS Functions on developing Key Risk and Quality Indicators (KxI), Service Level Agreements (SLAs) performance metrics through ownership of a self-service dashboard and metric reporting solutions. The position will be an avid participant on vendor governance meetings and support resolution of CAPAs and quality related issues.
The position requires high proficiency in quality management, an understanding of statistical deliverables across clinical development, and analytics, specifically being able to identify correlations, trend analysis, and detect cause-and-effect relations. The candidate will need to have a tenured experience and expertise in the management and oversight of a global workforce within the field of statistical and data management activities. The candidate will need to closely monitor the quality and timeliness of clinical trial deliverables, provide process guidance when needed, support creation and maintenance of onboarding materials, lead and direct prioritization and coordination of deliverables, and lead execution of quality oversight plans tactically within each function to ensure compliance.
Key Responsibilities will include, but are not limited to the following: - Support training curriculum and learning objectives with internal CDS team (BRIDGE) to mentor and onboard staff.
- Support CDS-Wide Outsourcing Vision & Strategy
- Review and author quality oversight plans with LT members that define practices related to quality assurance.
- Be an active steward and coordinator of tasks and workloads assigned to global CRO partner
- Actively participate in quality vendor discussions supporting the business on observations identified through metrics, CAPA and audit outcomes, and resourcing/staffing challenges (e.g. attrition/turnover).
- Support the transition to Planisware where needed and help provide input on resource algorithms.
- Provide strategic direction and input to CDS LT related to assessments in expansion of vendor services and capabilities and/or shifts in scope of work based on performance evaluations.
- Proactively monitor the health of the vendor relationship and foster a strong communication channel ensuring compliance and adherence to defined quality practices throughout study lifecycle.
- Help to develop random sampling techniques which monitor quality and completeness of assigned deliverables.
- Align with Quality and Medical Governance and CDS teams (Bridge) to holistically support quality throughout the function and remain in inspection-readiness state.
- Manage Quality Metrics within SONAR (metric dashboard) & Report Quarterly to CDS LT
- Accountable for completion of Quality Oversight Plans & Vendor Quality Agreements
- Work closely with CDS extended leadership members on resource model changes (internal vs offshore), to ensure the change is embedded within Resource Management Systems and monitored correctly through staffing reports post implementation.
- Be a leader in performance oversight through 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.
- Lead quality oversight of staffing engagements, through direct delivery of the following:
- Partner closely with CDS LT and their management teams to develop robust quality oversight and management of vendor services.
- Guide discussions on Vendor SLAs with Function Quality Oversight Lead
- Lead areas of process improvement that allow for seamless delivery within CRO and FSP operations.
Qualifications
- Clinical trial development operations experience, specifically related to resource management and quality assurance.
- Expertise working in global teams, across various time-zones to achieve clinical trial milestones.
- Able to lead and mentor effective cross functional teams
- Ability to motivate large diverse teams to achieve a common set of goals.
- Remains current and has deep-knowledge of GCP and ICH guidelines, specifically as it relates to quality oversight, quality assurance, and risk management.
- BA/BS with 12+ years' relevant experience
- Strong understanding of statistical programming and biostatistical deliverables within clinical trial execution including but not limited to TFLs, SDTMs, ADaMs, SAP, CSR, etc.. in order to be able to facilitate, direct, coordinate, and support refinement of process(es) for work being completed within a global FSP model.
- Knowledgeable in Resource Management Systems (preferably Planisware).
- Experience in working through organization and resource model changes (e.g., transition to outsourcing, augmented workforce, function service providers, etc.…)
- Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills.
- PharmD/PhD with 8+ years' relevant experience
- Mature experience developing analytical tools (metrics, graphs) within reporting platforms (e.g., Tableau, BI, SpotFire).
- Passionate about continuous improvement and establishing new procedures which embrace technological solutions and/or automation via advanced programmatic solutions, specifically in the areas of quality and staffing management.
- Expertise working in global teams, across various time-zones and those of a hybrid work matrix (FTE and Functional Service Provider (FSP) staff) to achieve clinical trial milestones.
- MA/MS/MBA with 10+ years' relevant experience
- Ability to problem-solve using data-driven approaches to help determine the best path forward.
- Experience leading complex changes, which require in-depth change management and transition plans
- Strong project management expertise able to support teams through bottlenecks and areas of resource impact.
- Superior communication and personal skills to help coach and mentor external CRO workforce.
- Strong experience in data analysis and demonstrated critical thinking skills
Gilead Core Values
- Excellence (Being Your Best)
- Inclusion (Encouraging Diversity)
- Accountability (Taking Personal Responsibility)
- Integrity (Doing What's Right)
- Teamwork (Working Together)
As an equal opportunity employer, Gilead Sciences has a strong commitment to diversity and inclusion. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
[email protected] for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.
We are an equal opportunity employer. Apply online today at www.gilead.com/careers.
The salary range for this position is: $195,245.00 - $252,670.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For Additional Benefits Information, Visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
[email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees And Contractors
Please log onto your Internal Career Site to apply for this job.
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