Gilead Sciences · 2 weeks ago
Clinical Trials Manager, Biomarker/Bioanalytical Operations
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$147K/yr - $190K/yr
3+ years expGilead Sciences is committed to creating a healthier world by developing therapies for various diseases. They are seeking a Clinical Trials Manager to oversee the execution of clinical studies and manage biomarker and bioanalytical vendors, ensuring compliance with regulatory guidelines and high-quality data collection.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs
Participate in multiple Phase 1-4 clinical study teams
Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)
Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent
Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work
Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy
Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track
Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors
Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
Review of relevant documents including protocols, informed consents, and relevant study documents
Must be able to understand, interpret and explain protocol requirements to others
Assists in determining the activities to support a project’s priorities within functional area
Contributes to development of RFPs and participates in selection of CROs/vendors
Able to examine functional issues from an organizational perspective
May contribute or participate in special projects
Develops tools and processes that optimize project efficiencies and effectiveness
Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
May contribute to development of abstracts, presentations and manuscripts
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support Process development and implementation
Provides knowledge and expertise on country specific regulations
Participates in and manages project meetings and conference calls with vendors and cross-functional teams
Develops tools and processes that optimize project efficiencies and effectiveness
Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations
May be required to present at internal or external meetings (i.e., investigator meetings)
Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support
Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements
Travel may be required
Qualification
Required
Bachelor's degree and 5+ years of relevant experience; OR
Masters' degree and 3+ years of relevant experience
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-20
2026-01-16
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