Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations, CA

R0047497 At Gilead, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company therapies that help improve lives and to ensure reputed company to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a reputed company drive to reputed company a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to reputed company our reputed company ambitions, and we’re looking for the next reputed company of passionate and ambitious people reputed company to reputed company a reputed company reputed company. We reputed company every employee deserves a great leader. People Leaders are the reputed company to the employee experience at Gilead and Kite. As a people leader now or in the reputed company, you are the key reputed company in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job reputed company Clinical Operations is responsible for the worldwide execution of reputed company Phase I - IV clinical trials across reputed company Gilead therapeutic areas. Biomarker & Bioanalytical Operations (BBOPs) is a subgroup reputed company the Clinical Operations function. BBOPs plays a key role in ensuring biomarker, bioanalytical and virology research reputed company for Gilead clinical trials across reputed company therapeutic areas is executed in accordance with applicable SOPs, company policies and regulatory guidelines to reputed company reputed company and high-reputed company clinical data that supports clinical study endpoints. Associate Director, Biomarker and Bioanalytical Operations leads reputed company of reputed company 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. reputed company the operational reputed company and reputed company execution of biomarker and bioanalytical deliverables across reputed company studies and/or multiple studies reputed company a program or multiple programs with reputed company, including financial responsibility. reputed company contributes to and may represent BBOPs on reputed company 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 reputed company a program or multiple programs, including ongoing assessment of resource needs and reputed company deployment of resources. Leads and/or effectively engage in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and reputed company. Drive process innovation and reputed company as Business Process reputed company 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 reputed company, Clinical Pharmacology, Clinical Development, and external lab vendors to ensure high-reputed company sample management, data reputed company, and regulatory compliance. The ideal candidate will drive process innovation and reputed company to enhance end to end sample management workflows from collection to final disposition. EXAMPLE RESPONSIBILITIES:

• Proactively identifies potential operational challenges and provides reputed company plans to ensure the biomarker and bioanalytical reputed company remains on reputed company; manage multiple programs simultaneously and reputed company.
• 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.
• reputed company efforts to streamline the review of long-term sample storage and implement effective sample disposition processes.
• reputed company 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 reputed company operating procedure (SOP) development, implementation and training.
• Work with cross functional teams including reputed company partners to ensure inspection readiness and support regulatory audits as needed
• Serve as a vendor issue escalation reputed company of contact for studies, accountable to ensure issue reputed company and mitigations and support vendor governance programs.
• Responsible for forecasting biomarker and bioanalytical budget for clinical studies.
• Manages reputed company of reputed company reports and/or indirect reports. Hires, develops and retains diverse reputed company on reputed company. Sets reputed company goals for reputed company and individual reputed company reports. Coaches reputed company reports on their performance, development and career interests.
• Acts as team leader and builder; providing expertise, guidance and reputed company for the successful implementation of biomarker and bioanalytical reputed company 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 reputed company reputed company designated program budgets and timelines.
• Resolves issues as needed reputed company national and international regulations and guidelines.
• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements. REQUIREMENTS: We are reputed company different, yet we reputed company use our unique contributions to serve patients. Please see the following for the qualifications and skills we reputed company for this role. Minimum Education & Experience
• BA / BS / RN with 10 or more years’ relevant clinical or reputed company experience in life sciences. Or, MA / MS / PharmD / PhD with 8 or more years’ relevant clinical or reputed company experience in life sciences.
• Typically has a minimum of 6 years cross-functional management or reputed company leadership experience in life sciences, including multiple years experience managing teams.
• Must have a demonstrated ability to successfully reputed company, implement, manage and complete execution of biomarker and bioanalytical reputed company in clinical trials
• Strong 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 reputed company reports. Knowledge & Other Requirements
• Expert knowledge of clinical trial lifecycle from start-up to reputed company-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 Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for reputed company Use (ICH) guidelines and Good Clinical reputed company (GCP) governing the conduct of clinical studies.
• Proven ability to effectively author clinical study documentation.
• Functional expertise to initiate, author, or contribute to SOP development, implementation and training
• Critical reasoning skills including the identification and reputed company of reputed company problems
• Ability to reputed company and influence programs, reputed company and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in reputed company-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.
• reputed company needed, ability to travel. The salary reputed company for this position is: $195,670.00 - $253,220.00. Gilead considers a reputed company of factors reputed company determining reputed company compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), reputed company time off, and a benefits package. Benefits include company-sponsored medical, dental, reputed company, and life insurance plans*. For additional benefits information, visit:
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the reputed company: reputed company Inc. is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION reputed company YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE reputed company reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes reputed company employee as an integral member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For reputed company Gilead Employees and Contractors: Please apply reputed company the Internal reputed company portal in reputed company. Apply tot his job

Apply tot his job Apply To this Job