Sr Scientist, Drug Metabolism

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

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.

Essential Duties and Job Responsibilities:

• 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.

Basic Qualifications:

• Bachelor’s Degree and 8 Years’ Experience

OR

• Masters’ Degree and 6 Years’ Experience

OR

• PhD/ PharmD and 2 Years’ Experience

OR

• MD

Preferred Qualifications:

• 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/WinNonlin, MATLAB/SimBiology, R, or equivalent modeling tools.

• Proven ability to design, implement, and interpret complex modeling workflows, determine next steps based on quantitative insights, and effectively communicate results to project teams and senior management.

• Demonstrated intellectual curiosity and commitment to staying current with advances in biologics DMPK and modeling methodologies, supported by a track record of external visibility through publications, presentations, and/or professional organization involvement.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.