Clinical Pharmacology Modeling and Simulation - Principal Scientist at Amgen

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 collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Clinical Pharmacology, Modeling & Simulation- Principal Scientist

Live

What you will do

Lets do this. Lets 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

• Masters degree and 5 years of Clinical Pharmacology and Modeling & Simulation experience OR

• Bachelors 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.

Thrive

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.

careers.amgen.com

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.

Application deadline

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.