Sr Clinical Pharmacology Manager

Gilead Sciences•Foster City, CA

20d

About The Position

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. As a PBPK expert, your main role will be in adapting, developing, and applying mechanistic physiology-based pharmacokinetic (PBPK) models. These models may encompass both small and large molecule formats. The models will be used in a variety of applications, primarily drug-drug interactions and PK predictions for special populations (pregnancy, hepatic/renal impairment, pediatrics), but may also include translational PK, PBPK-PD and PBPK-QSP. The PBPK function will support key PK predictions for clinical pharmacology (DDIs, renal and hepatic impairment effects, pediatric extrapolations, etc.) in the support of trial design, regulatory submissions and trial waiver applications, as well as providing support for the determination of mechanism of action.

Requirements

8+ Years with BS OR 6+ Years with MS OR 2+ Years with PhD/PharmD OR 0+Years with MD

Nice To Haves

Proficiency in mathematical and computational skills needed for PBPK modeling work, including but not limited to ordinary differential equations, linear algebra, statistics, optimization, and parameter inference
Expertise in at least one PBPK software package such as GastroPlus, Simcyp, and PK-Sim (preferred)
Proficiency in relevant software and programming languages such as python, R, C++, Julia, or MATLAB and MATLAB SimBiology
Basic understanding of molecular and cellular biology including, for example, concepts from immunology, oncology, virology, cellular signaling, etc.
Basic understanding of concepts of drug development
3+ years of relevant experience and a PhD or PharmD degree
Experience with quantitative systems pharmacology (QSP) modeling
Experience with mechanistic PK/PD as well as compartmental PK/PD modeling
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.

Responsibilities

Develop PBPK models for small molecules, and potentially large molecule formats including mAbs, bispecific Abs, various Ab constructs, ADCs, etc.
Utilize existing PBPK frameworks such as GastroPlus, Simcyp, and PK-Sim (preferred) where appropriate
Develop minimal PBPK and custom PBPK models as needed using software such as R and MATLAB
Regularly communicate with cross-functional teams to develop and periodically update modeling strategy to ensure timely and impactful execution of modeling goals
Present model findings to clinical teams and incorporate feedback as needed
Provide expert guidance across teams as needed
Contribute to regulatory documents using the appropriate level of documentation and ensuring reproducibility
Maintain accurate records including data, assumptions, parameter values, model changes, etc. while developing models
Proactively identify opportunities for applying or adapting PBPK models to support portfolio and project needs
Author manuscripts describing model development and findings
Present modeling work externally at conferences and working groups
Serve as the PBPK subject matter expert to support Clinical Pharmacology with program-specific questions

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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.

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