Sr Scientist, Drug Metabolism

Job Description

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.

Specific Responsibilities:

The primary responsibility of this Biologics DMPK Senior Scientist position is to serve as an expert in pharmacokinetic (PK) and PK/PD modeling of biologics, providing strategic and scientific leadership on large molecule discovery and development project teams. The role emphasizes the application of advanced quantitative approaches, including mechanistic and empirical modeling, to characterize and predict the absorption, distribution, metabolism, and excretion (ADME) properties of protein therapeutics.

Additionally, responsibilities include designing and interpreting in‑vitro and in‑vivo studies, integrating data into mathematical models, and generating simulations to support dose selection and clinical translation. This role offers opportunities to serve as a project representative and departmental modeling expert, while also contributing to business development initiatives and external collaborations.

• Provide advanced PK and PK/PD modeling expertise on project teams across discovery and development stages, guiding the design and interpretation of nonclinical PK, toxicology, and pharmacology studies.
• Lead quantitative DMPK strategy for biologics programs, collaborating with interdisciplinary teams to integrate modeling approaches into decision‑making; communicate modeling insights and align strategies with scientists, collaborators, and management.
• Design, implement, and validate complex PK/PD and mechanistic models to address translational questions, support dose selection, and predict first‑in‑human exposures.
• Develop and refine modeling workflows for nonclinical study design, including simulation‑based approaches to optimize study parameters and interpret outcomes.
• Prepare study protocols and coordinate execution of nonclinical studies which may involve multiple functional areas and CROs.
• Work closely with project teams, line management and CROs to assure high quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions.
• Participate in business development and licensing evaluations.

• Bachelor’s Degree and 8 Years’ Experience
• Masters’ Degree and 6 Years’ Experience
• PhD / Pharm
  
  D and 2 Years’ Experience
• MD

• Ph.D. with 3+ years of post‑graduate industry experience in pharmacokinetics, drug metabolism, pharmaceutics, or a related life science field, with a primary focus on quantitative modeling for large molecule/biologics PK characterization across discovery and development.
• Strong foundation in pharmacokinetics and pharmacodynamics principles, with demonstrated ability to translate these concepts into mathematical models.
• Extensive experience in mechanistic PK/PD and multi‑compartmental modeling, including proficiency with software platforms such as Phoenix/Win Nonlin, MATLAB/Sim Biology, R, or equivalent modeling tools.
• Proven ability to design, implement, and interpret complex modeling workflows,…