Principal Scientist, Diagnostics

Gilead Sciences•Foster City, CA

About The Position

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.

Requirements

Demonstrated ability to develop diagnostic strategies for oncology programs that align biomarker hypotheses, clinical development objectives, assay requirements, and patient-selection needs.
Understanding of diagnostic platforms including but not limited to immunohistochemistry (IHC), next-generation sequencing (NGS), flow cytometry and digital pathology.
Knowledge of clinical study design, diagnostic regulatory requirements, and integration of diagnostic, clinical, regulatory, and commercial timelines across global development and lifecycle management.
Strong scientific leadership, communication, and collaboration skills, with the ability to work effectively in cross-functional teams, manage complex projects, and deliver results in a fast-paced matrix environment.
Detail-oriented, with excellent record keeping and organizational skills, and able to work independently as a flexible, results-oriented self-starter in a multidisciplinary environment on multiple teams simultaneously.
10+ years with BA/BS, 8+ years with MA/MS, or 2+ years with MD or PhD in a scientific discipline or related field.
Experience in diagnostic strategy or assay development supporting oncology drug development is preferred.

Nice To Haves

Proven publication record; understanding of IP, contracting terms, and provisions is desirable.

Responsibilities

Define diagnostic strategies for individual oncology programs, aligning biomarker objectives, clinical development plans, and broader portfolio diagnostic strategies in partnership with key cross-functional stakeholders.
Develop and oversee integrated diagnostic project plans, coordinating internal teams and external partners to ensure appropriate resourcing, budgets, regulatory activities, CRO support, and operational execution are in place to meet program objectives and timelines.
Lead Diagnostic Sub Teams to execute diagnostic strategy from inception through regulatory approval, leveraging cross-functional expertise, third-party diagnostic partners, and central laboratories across global regions.
Provide diagnostic subject matter expertise to multidisciplinary drug development teams.
Reporting to the Head of Oncology Diagnostics within the Diagnostics Group and participate as a member of relevant cross-functional drug development teams.
Represent the diagnostic function on multiple global program teams, ensuring diagnostic considerations are integrated into program strategy and timelines.
Lead Diagnostic Sub Teams and co-lead diagnostic partner teams to execute diagnostic strategy across multiple oncology programs.
Develop, articulate, and manage integrated diagnostic project plans in close collaboration with biomarker, regulatory, clinical development, clinical operations, quality, and external partner stakeholders.
Work independently in a fast-paced matrix environment, using strong collaboration, communication, and leadership skills to align stakeholders, marshal resources, and integrate diagnostic development into the broader drug development process.