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About the Role

The MARGO function operationalizes Non Interventional Studies scientifically led from MAR, conducting observational research and generating analysis results to inform decisions throughout the product lifecycle. This role provides end-to-end operational oversight of observational studies within the MAR portfolio across all therapeutic areas, supporting high-quality, compliant, and timely study execution through effective vendor oversight, risk management, and issue resolution.

Responsibilities

Track, prioritize, and manage the execution of observational studies across all TA portfolios.
Collaborate on strategic sourcing options to optimize the execution of the TA portfolio.
Manage vendor performance, issues, and escalate risks impacting the portfolio.
Oversee vendor oversight plans and conduct performance and quality checks of study deliverables.
Partner with vendor outsourcing to support initiation and execution of study vendor and service provider agreements.
Collaborate with MAR scientific leads to ensure alignment of study objectives and timelines.
Own end-to-end oversight of study deliverables, ensuring timely, high-quality completion.
Track study milestones, timelines, deliverables, and financials; proactively identify and mitigate risks.
Collaborate with MAR scientific leads to monitor resource utilization and assignment.
Ensure onboarding of study vendors and service provider resources.
Monitor end-to-end processes to ensure compliance with process requirements, regulatory guidelines, and study objectives.
Serve as an escalation point to resolve quality, scope, and timeliness issues.
Maintain regular communication with operational stakeholders, study vendors, and service providers.
Identify opportunities for process improvement, increased standardization, and operational efficiency.
Collaborate with other oversight roles within MAR to drive consistency and implement best practices.
Liaise with Quality on periodic quality reviews and other quality-related activities.
Escalate study-specific issues to Quality for guidance and consultation.

Requirements

Previous experience in study operations or project management providing operational and financial oversight of observational studies.
BS degree in Biology, Business, Operations Research, or equivalent.
Hands-on training and experience in managing study lifecycles in a GxP compliant environment.
Demonstrated experience in managing cross-functional study teams and vendor resources to balance priorities and timelines in a matrixed environment.
Proven ability to communicate the scope, requirements, expectations, and standards for executing observational studies.
Proven track record of assessing vendor proposals (e.g., timelines, deliverables, budget) to meet study objectives.
Demonstrated vendor management experience to conduct primary data collection and secondary data use studies.
Demonstrated ability to collaborate cross-functionally with program, study, and functional teams, and vendor resources.
Knowledge of global NIS regulatory landscape.
Experience in working with international entities to conduct observational studies.
Ability to work collaboratively with global cross-functional stakeholders.
Ability to communicate study requirements and results.
Strong problem-solving skills using data-driven approaches.
Excellent written and verbal communication skills.

Skills

Study operations
Project management
Operational oversight
Financial oversight
Observational studies
Vendor management
Risk management
Issue resolution
Cross-functional team management
Communication
Problem-solving
Data-driven approaches

Education Level

BS degree in Biology, Business, Operations Research or equivalent

About the Company

For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer, working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
The company fights against the world's biggest health challenges, and its 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.
Gilead believes every employee deserves a great leader.
People Leaders are the cornerstone to the employee experience at Gilead and Kite.
As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfil their aspirations.
Join Gilead and help create possible, together.

Equal Opportunity

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.