Assoc Director, Operations Oversight Lead Medical Affairs Research Global Operations (MARGO)

Gilead Sciences•Foster City, CA

25d

About The Position

The MARGO function is part of the wider Medical Affairs Research (MAR) department within the Development organization and operationalises Non Interventional Studies scientifically led from MAR. MAR conducts observational research and generates analysis results to inform decisions throughout the product lifecycle across research, development, post-approval, and commercialization. Observational research is conducted on data collected from individuals assessed for biomedical, health and other outcomes, and includes observational studies and observational analyses. Source data for observational studies may be based on primary data collection, secondary data use, or both. The study results, generated using a rigorous process, provide insights and evidence for internal (e.g., program, safety) and external (e.g., regulators, healthcare providers) stakeholders. This role provides end-to-end operational oversight of observational studies within the MAR portfolio across all therapeutic areas (TA). This position supports the MAR team in high-quality, compliant and timely study execution of the study portfolio through effective vendor oversight, risk management and issue resolution. This role reports to the Director, MAARGO and is the primary point of contact for study operations for vendors and service providers. While not responsible for day-to-day execution, the role is responsible for collaborating with MAR scientific leads, Quality, Clinical Operations, Regulatory Affairs, Medical Affairs and other stakeholders to ensure vendors and service providers meet agreed-upon timelines and are compliant with process requirements and relevant regulatory guidelines.

Requirements

Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience

Nice To Haves

5+ years of experience in study operations or project management providing operational and financial oversight of observational studies
Degree in Biology, Business, Operations Research or equivalent
Hands-on training and experience in managing study lifecycles in 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 and 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

Responsibilities

Responsible for working with the MARGO Leadership Team to track, prioritize and manage the execution of observational studies across all TA portfolios
Collaborate with MARGO Leadership Team on strategic sourcing options to optimize the execution of the TA portfolio
Responsible for vendor performance management, issue management and escalation of risks impacting the portfolio
Responsible for the vendor oversight plans, and performance and quality checks of study deliverables per the vendor oversight process
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 across all stakeholders and vendors
Own end-to-end oversight of study deliverables, ensuring timely, high-quality completion aligned to TA priorities, with proactive risk identification and mitigation
Track study milestones, timelines, deliverables and financials; proactively identify and mitigate risks
Collaborate with MAR scientific leads to monitor utilization and assignment of resources to deliver on priorities established by the MARGO Leadership Team
Ensure onboarding of study vendors and service provider resources to support the study portfolio priorities established with the MARGO Leadership Team
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 with operational stakeholders, including vendors and service providers
Maintain regular communication with operational stakeholders, study vendors and service providers to ensure delivery against priorities and commitments
Identify opportunities for process improvement, increased standardization and operational efficiency
Collaborate with other oversight roles within MAR to drive consistency across study execution processes and implement best practices
Liaison with Quality on periodic quality reviews and other quality related activities
Escalate study specific issues to Quality for guidance and consultation