Associate Director, Clinical Operations- Biomarker

Job DescriptionAssociate Director, Biomarker and Bioanalytical OperationsClinical 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. Actively contributes to and may represent BBOPs on strategy teams (e.g. Biomarker Sub teams) as applicable, including providing input and support to Directors as needed. 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.ResponsibilitiesProactively identifies potential operational challenges and provides resolution plans to ensure the biomarker and bioanalytical strategy remains on track; 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.Lead efforts to streamline the review of long-term sample storage and implement effective sample disposition processes.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 neededServe 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. Hires, develops and retains diverse top talent on the team. Sets clear goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.Acts as team leader and builder; providing expertise, guidance and oversight for the successful implementation of biomarker and bioanalytical strategy for clinical trials and programs.Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams to ensure efficient execution of the study biomarker & bioanalytical strategy within designated program budgets and timelines.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.REQUIREMENTSWe are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.BA / BS / RN with 10 or more years’ relevant clinical or related experience in life sciences. 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 trialsStrong knowledge of clinical trial processes, thorough knowledge of sample management, and regulatory requirements.Experience working with central labs, specialty lab vendors and CROs.Typically has multiple years managing direct reports.Knowledge & Other RequirementsExpert 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.Thorough knowledge of FDA, EMA, and other applicable national regulations, ICH guidelines and Good Clinical Practice (GCP).Proven ability to effectively author clinical study documentation.Functional expertise to initiate, author, or contribute to SOP development, implementation and trainingCritical reasoning skills including the identification and resolution of complex problemsAbility to lead and influence programs, projects and/or initiatives.Strong interpersonal skills and understanding of team dynamics.Proven ability to work successfully in a team-oriented, highly-matrixed environment.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.Strong communication and organizational skills.When needed, ability to travel.Compensation & BenefitsThe salary range for this position is: $195,670.00 - $253,220.00.Benefits include company-sponsored medical, dental, vision, and life insurance plans; eligible for discretionary annual bonus and stock-based long-term incentives; paid time off and a benefits package.For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeingEqual OpportunityGilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and to fostering an inclusive work environment. See the full policy for details on eligibility, accommodations, and nondiscrimination. #J-18808-Ljbffr