Sr Clinical Pharmacology Manager at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

8+ Years with BS OR 6+ Years with MS OR 2+ Years with PhD/PharmD OR 0+ Years with MD
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 (Preferred)
Expertise in at least one PBPK software package such as GastroPlus, Simcyp, and PK-Sim (preferred) (Preferred)
Proficiency in relevant software and programming languages such as python, R, C++, Julia, or MATLAB and MATLAB SimBiology (Preferred)
Basic understanding of molecular and cellular biology including, for example, concepts from immunology, oncology, virology, cellular signaling, etc. (Preferred)
Basic understanding of concepts of drug development (Preferred)
3+ years of relevant experience and a PhD or PharmD degree (Preferred)

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

Skills

PBPK

Physiology-Based Pharmacokinetic Modeling

Drug-Drug Interactions

PK Predictions

Special Populations

Hepatic Impairment

Renal Impairment

Pediatrics

Translational PK

PBPK-PD

PBPK-QSP

Clinical Pharmacology

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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