Current jobs related to Clinical Pharmacology Modeling and Simulation - Thousand Oaks - Oaks Gardens Place
-
Clinical Pharmacology Modeling and Simulation
2 months ago
Thousand Oaks, United States Amgen 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 achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Senior Scientist
2 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Clinical Pharmacology Modeling and Simulation
2 weeks ago
Thousand Oaks, United States Amgen Full timeJoin Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...
-
Thousand Oaks, California, United States Amgen SA Full timeTransforming Lives through Innovative MedicineAt Amgen, we are dedicated to serving patients living with serious illnesses. Our mission drives us to research, manufacture, and deliver innovative medicines that help people live longer, fuller, and happier lives.Job SummaryWe are seeking a highly skilled Senior Principal Scientist to lead clinical pharmacology...
-
Clinical Pharmacology Modeling and Simulation
3 weeks ago
Thousand Oaks, United States Amgen Full timeJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on...
-
Senior Scientist
4 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Clinical Pharmacology Scientist
7 days ago
Thousand Oaks, California, United States Amgen Full timeCareer Opportunity in Clinical PharmacologyAmgen is seeking a highly skilled Senior Clinical Pharmacology Scientist to join our team. As a key member of our clinical pharmacology group, you will be responsible for designing and implementing clinical pharmacology studies, analyzing data, and providing expert advice to cross-functional teams.Key...
-
Senior Engineer
1 week ago
Thousand Oaks, California, United States Amgen Full time**Transform the Lives of Patients with Amgen** At Amgen, we're committed to serving patients living with serious illnesses. Our mission drives all that we do, and we're seeking a talented Senior Engineer - Modeling and Simulation to join our team. As a member of our Combination Product Operations Digital and Data Strategies group, you'll develop and deploy...
-
Senior Engineer
2 weeks ago
Thousand Oaks, California, United States Amgen Full timeAbout AmgenAt Amgen, we're driven by a passion to serve patients living with serious illnesses. Our mission is to discover, develop, and deliver innovative therapies that improve lives. We're a collaborative, innovative, and science-based culture that values diversity, equity, and inclusion.Job SummaryWe're seeking a Senior Engineer - Modeling and Simulation...
-
Senior Engineer
2 weeks ago
Thousand Oaks, California, United States Amgen Full timeAbout AmgenAt Amgen, we're driven by a passion to serve patients living with serious illnesses. Our mission is to discover, develop, and deliver innovative therapies that improve lives. We're a collaborative, innovative, and science-based culture that values diversity, equity, and inclusion.Job SummaryWe're seeking a Senior Engineer - Modeling and Simulation...
-
Senior Engineer
2 weeks ago
Thousand Oaks, California, United States Amgen Full timeAbout AmgenAt Amgen, we're driven by a passion to serve patients living with serious illnesses. Our mission is to pioneer the world of biotech in our fight against the world's toughest diseases. With a focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the...
-
Senior Engineer
4 weeks ago
Thousand Oaks, California, United States BioSpace, Inc. Full timeJob DetailsAt BioSpace, Inc., we're committed to serving patients with serious illnesses. Our mission drives all that we do, and we're seeking a talented Senior Engineer to join our team.We've been pioneers in the biotech industry since 1980, helping to develop innovative medicines that improve patients' lives. As a member of our team, you'll contribute to...
-
Associate Scientist- Oncology
3 months ago
Thousand Oaks, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Software Engineer
4 weeks ago
Thousand Oaks, California, United States Amgen Full timeAbout the RoleWe are seeking a highly skilled Senior Engineer – Modeling and Simulation to join our Combination Product Operations Digital and Data Strategies group. As a key member of our team, you will develop and deploy state-of-the-art advanced computational technologies and empirical and first principles models to improve process understanding,...
-
Senior Principal Scientist
3 weeks ago
Thousand Oaks, California, United States Amgen SA Full timeSenior Principal Scientist - PKDMAmgen is seeking a highly skilled Senior Principal Scientist to join our PKDM team. As a subject matter expert in ADME/PK, you will play a critical role in the development of small molecule therapeutic drug candidates.Key Responsibilities:Serve as a functional PKDM representative and subject matter expert on the ADME/PK of...
-
Clinical Therapist
3 weeks ago
Thousand Oaks, California, United States Thriveworks Full timeJob Title: Clinical Social WorkerThriveworks is a clinician-founded national private practice group with a mission to help people live happy, successful lives. We are seeking a Licensed Clinician to provide a mix of telehealth and face-to-face sessions in Thousand Oaks, CA.Qualifications:Fully and independently licensed as a LCSW in CaliforniaLicensed and...
-
Scientist
7 days ago
thousand oaks, United States Beacon Hill Full timeJob Summary: We are seeking a highly motivated Scientist to join our research team. The successful candidate will contribute to the discovery and development of novel therapeutics, utilizing their expertise in molecular biology, biochemistry, and/or related fields. This role will involve designing and conducting experiments, analyzing data, and collaborating...
-
Scientist
7 days ago
Thousand Oaks, United States Beacon Hill Full timeJob Summary: We are seeking a highly motivated Scientist to join our research team. The successful candidate will contribute to the discovery and development of novel therapeutics, utilizing their expertise in molecular biology, biochemistry, and/or related fields. This role will involve designing and conducting experiments, analyzing data, and collaborating...
-
Director of Commercial Forecasting, Oncology
4 days ago
Thousand Oaks, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled and experienced Director of Commercial Forecasting, Oncology to join our team at BioSpace, Inc. This role will be instrumental in driving commercial success and shaping future strategies for our in-market assets.The successful candidate will oversee a team of dedicated individuals, providing strategic guidance and...
-
Clinical Nurse Coordinator ICU
1 week ago
Thousand Oaks, California, United States Los Robles Regional Medical Center Full timeJob SummaryThe Clinical Nurse Coordinator (CNC) plays a vital role in ensuring high-quality, patient-centered care in the ICU. This dynamic professional will collaborate with the management team to direct, monitor, and evaluate nursing care, serving as a resource for staff and modeling a commitment to the organization's values.Key Responsibilities:Assist...
Clinical Pharmacology Modeling and Simulation
2 months ago
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.
Clinical Pharmacology, Modeling & Simulation– Principal Scientist
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 Thousand Oaks, CA location. In this vital role you will be responsible for clinical pharmacology components of one or more general medicine clinical program (cardiovascular, metabolic, neuroscience, bone, nephrology, inflammation, or hematology disease areas), including study design, protocol preparation and reporting. In this vital role you will integrate results into regulatory filings and product labels. Possess understanding of PKPD modeling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with other R&D partners.
Key Responsibilities
Plans all necessary non–compartmental analyses to support project team decisions, publications, and reporting.
Designs clinical pharmacology components of drug development project clinical plans and provides clinical pharmacology expertise to project teams including plan, design and oversight of clinical pharmacology studies.
Implementing clinical pharmacology standard methodologies consistently.
Planning and implementation of PKPD analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
Contributes to the analysis of pre–clinical PKPD data for selection of FIH dose levels. Ensures adequate safety margins exist for selected dose levels.
Preparation of clinical pharmacology contributions to regulatory documents including Investigator Brochures, EOP2 meetings, IND, NDA/BLA. Leads resolution of clinical pharmacology queries from drug regulatory agencies, contributes in writing and reviewing responses to regulatory queries.
Plans timing for, designs, leads, and may act as clinician for healthy volunteer phase I and dedicated Clinical Pharmacology studies including (but not limited to) SAD/MAD, DDI, Food–Effect, ADME, Hepatic/Renal Impairment, BA/BE, and PK bridging.
Contribute recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and Development teams and in regulatory documentation.
Influences external environment through methods such as publication and presentations.
Collaborating with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
This position is based in Amgen, Thousand Oaks 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.
Win
What 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:
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 biopharmaceutics 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.
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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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
Apply now 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. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
