Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor's degree in a life science, engineering, or a related field
Minimum 5 years of experience in clinical operations, biomarker, or bioanalytical operations
Proven leadership experience in a clinical operations or biomarker/bioanalytical operations role
Strong understanding of clinical trials, regulatory compliance, and quality management systems
Excellent communication, coaching, and leadership skills
Ability to work in a fast-paced environment and prioritize multiple projects simultaneously
Strong analytical and problem-solving skills
Experience with biomarker and bioanalytical data management systems
Familiarity with clinical trial management systems (e.g. eCR, eRA, etc.)
Strong relationship-building and stakeholder management skills

Responsibilities

Lead a team of direct and/or indirect reports, including hiring, developing, and retaining top talent
Develop and implement biomarker and bioanalytical strategy for clinical trials and programs
Establish strong cross-functional relationships with internal and external stakeholders
Serve as a vendor issue escalation point for biological sample analysis
Collaborate with study teams, clinical data management, research biomarker teams, bioanalytical chemistry, clinical pharmacology, clinical development, and external lab vendors
Manage multiple studies within a program or multiple programs, including resource management and quality control
Develop and implement operational strategies to ensure timely and high-quality clinical data
Actively contribute to strategy teams, including providing input and support to Directors as needed
Represent BBOPs on strategy teams, including providing input and support to Directors as needed
Drive process innovation to enhance end-to-end sample management workflows

Skills

Clinical Operations

Biomarker

Bioanalytical Operations

Leadership

Team Leadership

Operational Strategy

SOPs

Regulatory Guidelines

Clinical Trials

Employee Engagement

Employee Development

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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