- PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD).
- 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
- Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling to inform clinical study designs, optimal dosage selection in target patient populations, characterization of drug-drug interactions, dosing in special populations, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling required.
- Established track-record of Model Based Drug Development (MIDD).
- Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
- Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
-
Amgen South San Francisco, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collabor ...
-
BioSpace South San Francisco, United StatesJob Details · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global col ...
-
Amgen South San Francisco, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who ...
-
Pharmacometrician
1 week ago
Pfizer South San Francisco, United States Full timeJOB SUMMARY · With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners. · Conduc ...
-
Beacon Hill South San Francisco, United StatesPosition Summary: · Seeking a Senior Research Associate for our Pharmacology and Toxicology group. This individual will play a key role in the development and execution of preclinical models to understand the efficacy and PK/PD relationships of our small molecule agents under de ...
-
Director, Clinical Scientist
1 week ago
HI-Bio South San Francisco, United StatesJOB TITLE: Director, Clinical Science · DEPARTMENT: Clinical Development · LOCATION: South San Francisco, California · TYPE: Full-Time (Onsite / Hybrid) · Are you an experienced scientist with clinical research experience in kidney and/or immune-mediated diseases? Join HI-Bio, In ...
-
Research Associate III
3 weeks ago
MassGenics South San Francisco, United States ContractInnova Solutions is immediately hiring for a Research Associate - III · Position type: Full time time Contract · Duration: 12 months · Location: South San Francisco, CA · As a Research Associate - III, you will: · Job Description: · The mission of the Investigative Toxicology g ...
-
Scientist I/II, Investigative Toxicology
3 weeks ago
Innova Solutions South San Francisco, United States ContractInnova Solutions is immediately hiring for an Scientist I/II, Investigative Toxicology, · Position type: Full time Contract · Duration: 12+ months · Location: South San Francisco, CA · As an Scientist I/II, Investigative Toxicology, you will: · Summary: · This position is in th ...
-
Structure Therapeutics Inc South San Francisco, United StatesPOSITION SUMMARY · The Senior Director, Clinical Pharmacology and Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pipeline molecules. The position will contribut ...
-
Senior Director, Clinical Pharmacology
1 week ago
Maze Therapeutics South San Francisco, United StatesThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Senior Director, Clinical Pharmacology
3 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
-
Director, Quantitative Pharmacology
6 hours ago
Denali Therapeutics South San Francisco, United StatesDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. The Company is seeking to hire a Director, Quantitative Pharmacology within the Quant ...
-
Senior Director, Clinical Pharmacology
6 hours ago
BioSpace South San Francisco, United StatesJob Details · The Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmac ...
-
BioSpace South San Francisco, United StatesJob Details · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamen ...
-
Alumis Inc South San Francisco, United StatesAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
Alumis Inc South San Francisco, United StatesAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
Structure Therapeutics South San Francisco, United StatesJob Description · Job DescriptionSalary: · POSITION SUMMARY · The Senior Director, Clinical Pharmacology and Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pip ...
-
Alumis Inc. South San Francisco, United States Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change t ...
-
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Director, Quantitative Pharmacology
3 weeks ago
BioSpace South San Francisco, United StatesJob Details · HOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global col ...
Principal Scientist, Clinical Pharmacology, Modeling - South San Francisco, United States - Amgen Inc.
![Amgen Inc. background](https://contents.bebee.com/companies/us/amgen-inc/background-19HYh.png)
Description
JOB ID:
R LOCATION:
US - California - South San Francisco
WORK LOCATION TYPE:
Flex Commuter / Hybrid
DATE POSTED:
Feb
14, 2024 CATEGORY:
Scientific
SALARY RANGE:
142,936.00 USD - 171,592.00 USD
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Principal Scientist, Clinical Pharmacology, Modeling & Simulation
Live
What you will do
Let's do this. Let's change the world.
The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist at its South San Francisco, CA location.
In this vital role you will be responsible for the development and implementation of the Quantitative Clinical Pharmacology, Modeling and Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T cells-based therapies in addition to small molecule & mono-clonal antibodies.
The Principal Scientist will be Subject Matter Expert who will apply innovative Quantitative Clinical Pharmacology approaches to guide optimal drug development including Pharmacokinetic/Pharmacodynamic (PK/PD) modeling, Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK-Pharmacodynamic (M-PBPK-PD) modeling and Quantitative Systems Pharmacology (QSP) modeling to ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal drug development.
This position is based in Amgen, South San Francisco site and candidates that can be based at this site are preferred.
Amgen also offers Flexible work models including working from home options and consideration can also be given to qualified remote candidates.
WinWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Master's degree and 5 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Bachelor's degree and 7 years of Clinical Pharmacology and Modeling & Simulation experience
Preferred Qualifications:
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Apply Now