Sr. Clinical Pharmacologist I (Modeling/ Simulation)
Sr. Clinical Pharmacologist I (Modeling/ Simulation)
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
As a Sr. Clinical Pharmacologist, I, you will have responsibility and accountability for clinical pharmacology programs at Gilead. You will have unparalleled opportunity to be involved with several aspects the product development process. From first-in human through approval and post-marketing activities, you will provide input into a breadth of products within your therapeutic area. We seek to provide a rewarding career and a continuous learning experience.
- Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for small/large molecule drug development
- Strong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (NCA, population modelling, PK/PD, literature meta-analyses, exposure-response analyses etc)
- Application of physiologically-based pharmacokinetic (PBPK) modeling analysis to support dose decisions in clinical trials and simulation of drug-drug interactions for quantitative risk assessment is a plus.
- In-depth knowledge and expertise with modeling and simulation software programs such as (NONMEM, R, S-Plus, Monolix, SimCYP, GastroPlus. Etc.)
- Independently runs pharmacology trials that are of higher complexity both in scope and volume.
- Manages timelines and assists in budgets to insure prompt and accurate execution of clinical studies.
- Analyzes complex problems in component parts and to identify causal relations.
- Demonstrates a strong understanding of applied medicine.
- Anticipates problems that may occur in clinical trials and develop solutions for them using precedents or original thinking.
- Conducts clinical pharmacology studies in line with clinical PK and product development strategies.
- Designs and works with CRA regarding implementation and conduct of clinical pharmacology studies
- Analyzes, interprets, and writes reports for clinical and regulatory submissions.
- Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.
- Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.
- Analyzes moderately complex problems in component
- Assists in the implementation of the Phase I/II clinical development plans for complex product development strategies.
- Designs and works with CRA and CTM management regarding implementation and conduct of clinical pharmacology studies.
- Directs the activities and resources, for both internal and external contractors/vendors.
- Analyzes, interprets, and writes, reports for clinical and regulatory submissions.
- Leads multiple complex clinical pharmacology studies.
- Develops and implements new clinical pharmacology
- Provides strategic leadership for the Phase I/II clinical development plans for project compounds and assists in implementation.
- Responsible for planning and conducting clinical pharmacology studies and leading multiple study teams.
- Oversees study related activities and resources, both internal and with external contractors/vendors.
- Analyzes, interprets, and writes highly complex reports for clinical and regulatory submissions.
- Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs
- parts and to identify causal relations.
- Contributes to and represents department on multifunctional project teams.
- Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.
- In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.
- Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.
- 5+ years of experience and an MD, PhD or PharmD degree in pharmacokinetics or a related scientific discipline.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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