[Remote] Associate Director, Clinical Data Science Compliance Oversight at Gilead Sciences

United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's Degree and Ten Years’ Experience OR Master's Degree and Eight Years’ Experience OR PhD and Two Years’ Experience
Preferred: 10 years of relevant experience with a BS degree in life sciences or related field
Preferred: Significant experience advising business functions in the biopharma industry on quality matters
In-depth knowledge of GCP and understanding of regulatory requirements applicable to the conduct of clinical trials

Responsibilities

Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives
Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations
Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions
Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods
Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions
Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities
Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response. Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities
Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change
Analyze new regulations and policies with emphasis on Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact
Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers

Skills

Key technologies and capabilities for this role

GCPQMSClinical Data ScienceQuality ManagementRisk ManagementRegulatory ComplianceClinical Trials

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What key skills and knowledge are required for this role?

The role requires in-depth knowledge of GCP, understanding of regulatory requirements for clinical trials, and expertise in quality management systems, risk assessment, and compliance oversight.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, a relentless drive to make a difference, continuous improvement, and a quality culture with shared accountability; people leaders are key to creating an inclusive environment where employees feel developed and empowered.

What makes a strong candidate for this Associate Director role?

Strong candidates will have deep expertise in GCP and clinical trial regulations, experience leading quality strategies, analyzing trends for improvements, and collaborating with stakeholders on audits, inspections, and risk mitigation.

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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