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Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

Foster City, United States

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access 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 relentless drive to make 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 achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver 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 Description

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

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 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 engages in Clinical Operations, cross-functional and/or country or regional organizational change initiatives and strategy. 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 also drive process innovation to enhance end to end sample management workflows from collection to final disposition.

EXAMPLE RESPONSIBILITIES:

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.
Serves as the key point of contact with internal and external stakeholders, for successful implementation of biological sample analysis strategy in Gilead programs, within designated program budgets and timelines.
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.

Serve as a vendor issue escalation point of contact for studies and support vendor governance programs.

Proactively identifies potential operational challenges and provides resolution plans to ensure the biomarker and bioanalytical strategy remains on track; manage multiple programs simultaneously and efficiently.

Manage cross-functional teams by clearly defining objectives and goals; cultivate stakeholder relationships to ensure efficient teams.
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 needed
Resolves issues as needed within national and international regulations and guidelines.
Ability to understand, interpret and explain protocol requirements to others
Assists in determining the activities to support a study, program, or project’s priorities within functional area and across TAs
Responsible for forecasting biomarker and bioanalytical budget for clinical studies.
May represent the department at cross-departmental events
Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

We 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.

Minimum Education & Experience

BA / BS / RN with 10 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS 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.
Experience working with central labs, specialty lab vendors and CROs.
Typically has multiple years managing direct reports.

Knowledge & Other Requirements

Expert knowledge of full cycle study management, 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 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 Human Use (ICH) guidelines and Good Clinical Practice (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 resolution of complex problems
Ability 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.

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base 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), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act 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 ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access 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 access 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 action, 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 each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make 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 Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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