Asset Management and Planning Director

Director - Real-World Evidence (Observational Research Operations) page is loaded Director - Real-World Evidence (Observational Research Operations)
Apply locations United Kingdom - Uxbridge posted on Posted 22 Days Ago job requisition id R0040516 For Current Gilead Employees and Contractors:
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Director - Real-World Evidence (Observational Research Operations)
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
Leveraging strong organization skills and clinical research operations background, the RWE Observational Research Operations Director plays an integral part in audit readiness through operational management and oversight of observational research studies and observational analyses within the Gilead Clinical Data Science Real-World Evidence (CDS-RWE) function.
The Director will lead efforts to ensure implementation and timely tracking of observational study milestones and deliverables. This role will be responsible for definition and implementation of metrics that monitor end-to-end observational research related activities and ensure audit readiness. 
This role is responsible to monitor trends, identify areas of improvement and collaborate with observational study stakeholders to continually improve processes for observational study conduct, quality, and compliance within the CDS-RWE function.
This is a complex role and requires collaboration with observational research stakeholders within RWE and with other functions like Clinical Operations, Medical Affairs, GHEOR and Biomarker Sciences.. The successful candidate has experience in drug-development process, clinical study lifecycle, regulatory compliance, and the uses of real world evidence in clinical development and safety endeavours. They have demonstrated attention to detail, program and project management expertise, and the ability to thrive in a complex, fast paced, matrixed organization. Additionally, the ideal candidate will have the proven ability to effectively communicate to senior leaders of the organization.
Accountable for ensuring that all studies led by the RWE function are audit ready and in compliance with local and national regulations and with Gilead procedural document
Ensures study documentation are in compliance with all applicable regulatory requirements, industry standards, and Gilead internal policies throughout the conduct of RWE studies; assists with responses to process deviations and staff training
Implement metrics to track quality and audit readiness of CDS-RWE deliverables
Build and lead capability to oversee observational study documentation including regulatory system management, trial master file, clinical trial management system (as needed) with almost no direct supervision.
Oversee the management of external vendors and research partners involved in real-world evidence studies, including contract negotiation, performance monitoring, and budget management. Independently organizes the operations, planning and contracting with external partners.
as new tools are developed to support observational study conduct, leads implementation efforts
Contribute to the strategic planning and execution of evidence generation initiatives to support product development, regulatory submissions, and market access activities
Implements project to build capability within CDS-RWE and coordinates process improvement initiatives with stakeholders within RWE, CDS and across Development organizations
Understands operational requirements and translates these into actions for quality and process improvement by interacting with employees and other teams
Lead development of communications strategy and preparation/content including CDS-RWE process trainings and project/initiative presentations
Exhibits expert knowledge related to the conduct of operational aspects of observational research, including observational studies and analysis. Has in-depth knowledge of the multidisciplinary functions involved in drug discovery and development and can proactively integrate multiple perspectives into research and/or development assignments.
Strong organizational management skills, including attention to detail and cross-functional communication
Implementation of program and/or portfolio management, tracking and dashboards
Highly resourceful and strategic thinker with strong emotional intelligence and operational rigor
Proven track record cross-functional collaboration within a matrix organization and successfully managing complex, time-sensitive, transformational projects
Proven track record of simultaneously managing multiple projects
Previous administrative and organizational development experience in real world evidence or clinical research
Expertise with processes and systems across RWE research disciplines, study, data and analysis lifecycles
The ideal candidate will have demonstrated leadership in strategic planning and execution
Experience driving large initiatives from framing the problem, conducting research / analysis to building the business and operational plans through to driving execution to success is required
Limited travel
BS, MS/MBA, PhD/PharmD or equivalent with significant experience in RWE/RWD/Epidemiology
Advanced degree in a scientific field relevant to RWE (e.g., epidemiology, public health, data science, clinical research) preferred
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. Inclusion (encouraging diversity)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). For Current Gilead Employees and Contractors:
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.
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