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
Acts as the Project Manager for assigned projects of moderate complexity. Responsible for developing and managing project plans, submission plans, timelines, cross-functional communications, meetings, actions, risks, and other key activities to ensure deliverables are met on time, within budget, and to the expected quality standards. Typically manages multiple projects and submissions concurrently and plays a key role in leading and leveraging cross-project synergies.
Specific responsibilities:
Serves as the Clinical Pharmacology Project Manager (CPPM), overseeing cross-functional Clinical Pharmacology Subteams (CPSTs) at the asset level to ensure effective management and execution of Clinical Pharmacology strategies that support program lifecycle management. Responsibilities include managing CPST meetings, tracking risks/decisions/actions, developing a portfolio-level view of timelines, setting team goals, and monitoring performance against those goals.
Leads the cross-functional Clinical Pharmacology Submission Working Group (CSWG) at the submission level to ensure alignment with global filing strategy and timelines. Responsibilities include developing, coordinating, and driving CSWG timelines for NDA/BLA submissions, overseeing risk and action management, managing meetings, and facilitating effective team communication and information flow.
Proactively manages and engages with cross-functional matrix teams comprising Clinical Pharmacology, Clinical Development, Biostatistics, Clinical Operations, Global Project Management, Medical Writing, Data Management, Statistical Programming, Regulatory Affairs, and other relevant stakeholders to ensure streamlined communication and information flow between CPST and the Global Development Team (GDT), and between CSWG and the Global Filing Team (GFT) and Study Management Team (SMT).
Manages specific Clinical Pharmacology deliverables and milestones, including but not limited to: Protocol Concept Sheets for early-phase programs, CSRs, QC/QA-ed PK/ADA/NAb data, PopPK datasets, exposure–response (E-R) datasets, PopPK reports, E-R reports, eSubmission packages, and regulatory components such as Modules 2.7.1, 2.7.2, and ISI, ensuring timely execution and delivery.
Supports operational excellence by developing and maintaining CPPM SharePoint sites, templates, best practices, job aids, and workflow diagrams. Also responsible for managing Clinical Pharmacology portfolio trackers/dashboards, document review and approval processes, and supporting process improvement initiatives as needed.
Essential duties and job functions
Drives progress of both product and non-product development programs
Applies project management standards to enable effective portfolio management
Leads moderately complex assignments, enabling multiple functions and teams to achieve project objectives within targeted timelines and allocated resources
Advises cross-functional teams on best practices to achieve project goals and objectives
Collaborates with key stakeholders across Development and Research, including Clinical Pharmacology Leads, PMx Leads, BioA Leads, Clinical Development, Global Project Management, Biostatistics, Clinical Operations, DMPK, and Regulatory Affairs
May manage external vendors or collaborators involved in assigned projects
Partners with colleagues across Global Development to ensure projects are completed on time, within budget, and to the expected quality standards
Key Accountabilities/Core Job Responsibilities
Manages task assignments and output quality of others supporting their projects
Provides matrix management to project teams; typically manages multiple teams simultaneously
Independently creates and manages project plans, timelines, risks, decisions, budgets, and resources for assigned projects, seeking advice as needed
Identifies cross-project synergies to leverage efficiencies and ensure consistency where appropriate
Leads moderately complex projects that enable Development initiatives to proceed; errors at this level may cause delays in achieving targeted outcomes
Identifies cross-project synergies that accelerate progress and maximize efficiencies.
Education and Experience
8+ years relevant experience with BA/BS
6+ years relevant experience with MA/MS/MBA
1+ Years relevant experience with PhD, PharmD, or equivalent
Multiple years of project management experience in the life sciences, including co-managing cross-functional project teams
Proven effectiveness in leading project teams within the life sciences domain
Comprehensive knowledge of full-cycle project management and end-to-end processes
Advanced proficiency in project management tools such as SmartSheet, Timeline Pro, Planisware, Visio, and OnePager, with demonstrated ability to apply these tools to enhance project efficiency and effectiveness
Strong understanding of the drug development process, with the ability to apply expertise across both large and small molecule projects
Independently resolves project-related challenges and seeks guidance when appropriate, ensuring solutions align with organizational objectives
Coaches and mentors less experienced team members in problem-solving and project execution
Experience with regulatory filings and Clinical Pharmacology is a plus
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.
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
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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.
Please apply via the Internal Career Opportunities portal in Workday.
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