[Remote] Clinical Trials Manager at Gilead Sciences

United States

Gilead Sciences Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates must possess a BS/BA degree in a nursing, science, or health-related field with a minimum of 5 years of trial management experience, or an MS/MA degree in a nursing, science, or health-related field with a minimum of 3 years of trial management experience. Extensive clinical research knowledge, cross-functional understanding of clinical trial methodology, and proficiency in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management are required.

Responsibilities

The Clinical Trials Manager will provide guidance and daily oversight for the successful management of international clinical trials, ensuring adherence to program budgets and timelines. Responsibilities include communicating project status and issues, overseeing operational aspects of clinical trial conduct from start-up to close-out, and contributing to the development of study-related documents such as protocols, informed consent forms, and monitoring plans. The role involves coordinating data review for analysis, participating in study strategy development, maintaining study timelines, and contributing to budget development. Additionally, the manager will contribute to RFPs, participate in vendor selection, provide guidance and training to CROs and vendors, manage CRO interactions, proactively identify and resolve study issues, organize internal and external meetings, and may participate in recruiting and mentoring junior team members.

Skills

Clinical Trials Management
Project Management
Budget Management
Timeline Management
Regulatory Guidelines
Data Quality
Global Clinical Trials
Phase 1-4 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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