Associate Director, Risk Based Quality Management (RBQM) at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Expert knowledge in RBQM for clinical trials, including adherence to ICH GCPs, regulatory requirements, and internal processes
Ability to provide guidance, training, and support on RBQM
Experience advising study teams on risk management activities and fostering cross-functional collaboration
Capability to contribute to development of central monitoring tools, Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators
Skills in determining monitoring strategies, mitigation plans, and authoring Central Monitoring Plans
Proficiency in facilitating cross-functional risk review meetings, risk signal interpretation, triage, communication, and issue resolution
Experience overseeing resolution of risk signals, escalation, and documentation
Technical expertise in developing and implementing data analytical tools for central monitoring
Ability to set up and test study-level central monitoring analytics
Skills in mapping, managing, and designing RBQM data flows integrating with clinical and operational databases at study, program, and enterprise levels
Proficiency in reviewing central monitoring analytics, investigating signals and actions, proposing suggestions, and following up on resolutions
Ability to identify, interpret anomalies, and monitor trends for systematic errors and issues at study, site, country levels

Responsibilities

Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes
Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management
Contribute to the development of new central monitoring tools to address risks and support study oversight
Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators
Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan
Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues
Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation
Support the development and implementation of data analytical tools used for central monitoring
Provide technical expertise to set up and test study-level central monitoring analytics
Map, manage, and design RBQM data flows to integrate with other relevant clinical and operational databases at study, program, and enterprise level
Review central monitoring analytics and assist with the investigation of signals and actions, including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions
Identify and interpret anomalies and monitor trends indicative of systematic errors and potential study, site, country, and/or study issues
Oversee timely resolution of identified issues

Skills

RBQM

Risk Based Quality Management

Clinical Operations

Clinical Trials

SOPs

Regulatory Guidelines

Phase I-IV

Quality Management

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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