Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness 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

Biotechnology, PharmaceuticalsIndustries

Requirements

BA or BS and 10+ years’ experience in compliance in pharmaceutical / biotechnology industry OR Masters and 8+ years’ experience in compliance in pharmaceutical / biotechnology industry
Project management experience and demonstration of proactive timeline management and driving teams to achieve timelines
Excellent working knowledge of FDA, EMA, and ICH GCP and other applicable regulations governing the conduct of clinical studies
Ability to build strong relationships to foster a collaborative approach to proactive compliance activities
Strong verbal, written, communication, and interpersonal skills
Strong leadership presence with demonstrated ability to lead

Responsibilities

Lead efforts to increase a culture of quality within the Clinical Operations organization
Collaborate with Clinical Operations to confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to core study execution, clinical trial sponsor oversight, deviation management and internal audit support
Lead Clinical Operations on internal deviations activities, including project management support for deviation management activities
Provide guidance for investigations, root cause analysis, development of corrective and preventive action (CAPA) plans for deviations and/or observations of non-compliance
Lead the internal audit/deviation response process within Clinical Operations and follow response/CAPA commitments to completion
Gather, analyze and share best practices and lessons learned from audit, inspection, and deviation activities for Clinical Operations
Work with relevant stakeholders to identify areas for improvement from audits, inspections, deviations, and corresponding appropriate next steps
Compile and communicate quality related metrics, risks, and quality challenges to teams and management
Determine, develop, execute Effectiveness Checks for applicable CAPAs

Skills

GCP

Inspection Readiness

Clinical Operations

Process Improvement

Quality Management

Risk Management

Deviation Management

Procedural Documents

Compliance

Clinical Trials

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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