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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.
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Job Description
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.
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.
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