Director - Real-World Evidence (Observational Research Operations)

Description

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.

Together we deliver life-saving therapies to patients in need. 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.

This role reports to the head of CDS-RWE Generation. 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.

Core Responsibilities

As the lead individual responsible for operational tracking and audit readiness for observational studies within the RWE function:

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; ensures study-level audit readiness for CDS-RWE; assists with responses to process deviations and staff training

Implement metrics to track quality and audit readiness of CDS-RWE deliverables

Develops, implements and monitors processes for end-to-end tracking, e.g., from study initiation, study contracting, study conduct, study closeout. Supports budgeting, invoicing, and forecasting of study costs; Builds a team to support these efforts independently with almost no direct supervision.

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.

In conjunction with the CDS-RWE Therapeutic Area study leads, oversees the development of study timelines and tracks milestones to ensure deliverables are met; Track CDS-RWE initiatives and achievements over the year; Create metrices for tracking the status of NIS to support study update presentations leadership. 

Work closely with Head of CDS-RWE Generation and study leads to track evidence generation activities in the appropriate system(s); Oversees study operational support including tracking and reporting; 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

Lead some key RWE Generation initiatives with cross-functional partners

Capabilities and Requirements

Exhibits expert knowledge related to the conduct of operational aspects of observational research, including observational studies and analysis. Understands key business processes and business areas. Acts as resource and provides direction to others. 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

Strong leadership and communication skills across functions; comfort in business and technical discussions. Able to influence without direct authority

Proven leadership experience, with a track record of effectively managing teams and driving results in a matrixed organization.

Expertise in administration of systems for study tracking and reporting

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

Self-starter who thrives in a fast-paced, collaborative, and innovative high-growth environment

Limited travel

Education

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

The Gilead Difference

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. But it’s just what we do that gives us an edge, it’s how we do it. We expect everyone at Gilead to lead by example, guided by our core values:

Integrity (always doing the right thing)

Teamwork (collaborating in good faith)

Excellence (working at a high level of commitment and capability)

Accountability (taking personal responsibility)

Inclusion (encouraging diversity)

Equal Employment Opportunity (EEO)

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). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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