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Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

Gilead SciencesSan Francisco, CA, United States
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Overview

Associate Director, Clinical Operations - Biomarker & Bioanalytical Operations at Gilead Sciences. Lead biomarker and bioanalytical strategy within clinical operations to support Phase I–IV trials across therapeutic areas, ensuring high-quality data, regulatory compliance, and efficient sample management.

Responsibilities

  • Lead a team of direct and / or indirect reports, setting clear goals, coaching performance and development, and ensuring diverse top talent retention.
  • Provide leadership for the biomarker and bioanalytical strategy across clinical trials and programs, including budget management and timeline adherence.
  • Partner with Clinical Operations Study Teams, Clinical Data Management, Research Biomarker Teams, Bioanalytical Chemistry, Clinical Pharmacology, Clinical Development, and external labs to ensure data integrity and regulatory compliance.
  • Represent BBOPs on strategy teams as applicable, contributing input and support to Directors as needed.
  • Manage resource needs and deployment across multiple studies or programs; lead or participate in cross-functional change initiatives and process improvements.
  • Act as Business Process Owner for BBOPs processes or serve as a subject matter expert (SME).
  • Drive process innovations to enhance end-to-end sample management workflows from collection to final disposition.
  • Develop and implement efficient consent codification and sample tracking processes aligned with regulatory and ethical standards.
  • Identify and address operational challenges, ensuring the biomarker and bioanalytical strategy stays on track while managing multiple programs.
  • Support vendor governance, serve as escalation point for study-related issues, and maintain relationships with internal / external stakeholders within budget and timeline constraints.
  • Ensure readiness for inspections and regulatory audits; contribute to SOP development, implementation, and training as assigned.
  • Forecast biomarker and bioanalytical budgets for clinical studies and participate in cross-departmental initiatives to improve department performance.

Qualifications

Minimum Education & Experience

  • BA / BS / RN with 10+ years of relevant clinical or life sciences experience, or MA / MS with 8+ years.
  • Typically 6+ years of cross-functional leadership experience in life sciences, including managing teams.
  • Proven ability to develop and execute biomarker and bioanalytical strategies in clinical trials.
  • Strong knowledge of clinical trial processes, sample management, and regulatory requirements.
  • Experience working with central labs, specialty labs, and CROs.
  • Experience managing direct reports.
  • Knowledge & Other Requirements

  • Expert knowledge of full-cycle study management from start-up to close-out.
  • Advanced knowledge of sample management best practices and tools; ability to improve efficiencies.
  • Experience implementing or optimizing sample tracking and inventory systems.
  • Familiarity with LIMS, sample tracking systems, and data reconciliation tools.
  • Knowledge of long-term storage policies and sample lifecycle planning.
  • Regulatory knowledge : FDA, EMA, ICH guidelines, and GCP.
  • Ability to author clinical study documentation and contribute to SOP development, implementation, and training.
  • Strong leadership, communication, and collaboration skills; ability to work in a matrixed environment.
  • Willingness and ability to travel as needed.
  • Compensation & Benefits

    The salary range for this position is : $195,670.00 - $253,220.00. This role may be eligible for discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance plans. Eligibility and details vary by role and location.

    Additional Information

    For more information about benefits, visit the Gilead compensation, benefits and wellbeing page. Gilead is an equal opportunity employer and is committed to fostering an inclusive work environment. Applicants requiring accommodation for the job application process may contact ApplicantAccommodations@gilead.com.

    Locations & Job Functions

    Notable locations include South San Francisco, Menlo Park, Redwood City and nearby areas.

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