Sr Clinical Pharmacology Manager

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.
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.

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.

 

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

 

Basic Qualifications:

• 8+ Years with BS
  OR

• 6+ Years with MS
  OR

• 2+ Years with PhD/PharmD
  OR

• 0+Years with MD
   

Preferred Qualifications:

• 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

• undefined

• Experience with quantitative systems pharmacology (QSP) modeling

  Experience with mechanistic PK/PD as well as compartmental PK/PD modeling

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.

 

The salary range for this position is: $169,320.00 - $219,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

For jobs in the United States:

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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