Associate Director, Clinical Operations- Biomarker

Job Description Associate Director, Biomarker and Bioanalytical Operations
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Biomarker & Bioanalytical Operations (BBOPs) is a subgroup within the Clinical Operations function. BBOPs plays a key role in ensuring biomarker, bioanalytical and virology research strategy for Gilead clinical trials across all therapeutic areas is executed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports clinical study endpoints.
Associate Director, Biomarker and Bioanalytical Operations leads a team of direct and/or indirect reports. Acts as a leader of managers and individual contributors with a People First approach focusing on employee engagement, development and team health. Lead the operational strategy and oversee execution of biomarker and bioanalytical deliverables across complex studies and/or multiple studies within a program or multiple programs with quality, including financial responsibility. Responsible for the resource management of multiple studies within a program or multiple programs, including ongoing assessment of resource needs and optimal deployment of resources. Leads and/or effectively engage in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and strategy. Drive process innovation and act as Business Process owner for BBOPs processes and/or serves as a SME.
This role partners closely with Clinical Operations Study Teams, Clinical Data Management, Research Biomarker Teams, Bioanalytical Chemistry, Clinical Pharmacology, Clinical Development, and external lab vendors to ensure high-quality sample management, data integrity, and regulatory compliance. The ideal candidate will drive process innovation and clarity to enhance end to end sample management workflows from collection to final disposition.
manage multiple programs simultaneously and efficiently.
Participates in and/or leads departmental or interdepartmental strategic initiatives, including contribution to the development of new systems and processes that help improve department/company performance.
Drive initiatives to improve sample inventory tracking, ensuring accuracy, visibility, and operational efficiency.
Develop and implement efficient processes for consent codification, ensuring alignment with regulatory and ethical standards.
Identify and execute improvements in end-to-end sample management workflows, from collection to final disposition.
As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
Work with cross functional teams including internal and external partners to ensure inspection readiness and support regulatory audits as needed
Serve as a vendor issue escalation point of contact for studies, accountable to ensure issue resolution and mitigations and support vendor governance programs.
Responsible for forecasting biomarker and bioanalytical budget for clinical studies.
Manages a team of direct reports and/or indirect reports. Coaches direct reports on their performance, development and career interests.
providing expertise, guidance and oversight for the successful implementation of biomarker and bioanalytical strategy for clinical trials and programs.
Resolves issues as needed within national and international regulations and guidelines.
Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
We are all different, yet we all use our unique contributions to serve patients. Or, MA / MS / PharmD / PhD with 8 or more years’ relevant clinical or related experience in life sciences.
Typically has a minimum of 6 years cross-functional management or related leadership experience in life sciences, including multiple years experience managing teams.
Must have a demonstrated ability to successfully develop, implement, manage and complete execution of biomarker and bioanalytical strategy in clinical trials
Strong knowledge of clinical trial processes, thorough knowledge of sample management, and regulatory requirements.
Typically has multiple years managing direct reports.
Expert knowledge of clinical trial lifecycle from start-up to close-out.
Advanced knowledge of clinical trial sample management best practices and tools and has shown ability to apply these to improve sample management efficiencies and effectiveness.
Experience implementing or optimizing clinical trial sample tracking systems and inventory management tools.
Familiarity with LIMS, sample tracking systems, and data reconciliation tools.
Familiarity with long-term storage policies, and sample lifecycle planning.
Proven ability to effectively author clinical study documentation.
Functional expertise to initiate, author, or contribute to SOP development, implementation and training
Ability to lead and influence programs, projects and/or initiatives.
Demonstrated effectiveness coaching, guiding and directing the work of others, effectively managing performance of others, and developing team capabilities.
Demonstrated effectiveness in proactively managing change.
When needed, ability to travel.
Benefits include company-sponsored medical, dental, vision, and life insurance plans; eligible for discretionary annual bonus and stock-based long-term incentives; xrczosw See the full policy for details on eligibility, accommodations, and nondiscrimination.