Sr Clinical Trials Manager at Gilead Sciences

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

10+ years’ relevant clinical or related experience in life sciences
Multiple years’ clinical or related experience in life sciences, including multiple years’ experience leading studies and project teams
Demonstrated abilities to effectively lead and manage a team and/or others

Responsibilities

Leads and oversees all components of assigned studies in partnership/collaboration with Clinical Program Managers
Manages actively clinical study budgets and exercises proactive financial oversight
May lead contract research organization (CRO) and vendor selection and, where applicable, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, and vendors
Collaborates with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met
Provides guidance and training to team members, CROs, vendors, and investigators on study requirements
Defines, develops, and oversees adherence to study timelines, including documentation and communications
Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs/vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans
Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials
May initiate, author, or otherwise contribute to SOP development and implementation
Participates in special projects
Presents at internal and external meetings
Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations
Assists in training new or less experienced colleagues
Ensures own and team’s work complies with established practices, policies and processes, and any regulatory or other requirements

Skills

Key technologies and capabilities for this role

Clinical Trials ManagementPhase I-IV StudiesSOP ComplianceRegulatory GuidelinesStudy LogisticsBudget ManagementTimeline ManagementTeam OversightClinical OperationsProgram Management

Questions & Answers

Common questions about this position

What is the employment type for this Sr Clinical Trials Manager position?

The position is full-time.

Is this Sr Clinical Trials Manager role remote or office-based?

This information is not specified in the job description.

What are the key responsibilities for this role?

The role involves leading and overseeing all components of assigned studies, managing clinical study budgets, leading CRO and vendor selection, collaborating cross-functionally, providing guidance and training, and overseeing study timelines and site compliance.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive, developmental, and empowering environment where every employee feels included and empowered to fulfill their aspirations.

What makes a strong candidate for the Sr Clinical Trials Manager role?

Strong candidates should have experience leading clinical studies, providing guidance to teams, managing budgets and timelines, overseeing CROs and vendors, and collaborating cross-functionally while ensuring compliance with protocols and regulations.

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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