Clinical Pharmacology, Modeling & Simulation- Senior Principal Scientist

Career Category

Scientific

Job Description

Job Description

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- Senior Principal Scientist

Live

What you will do

Let’s do this. Let’s change the world. The Senior Principal Scientist at Amgen is responsible for clinical pharmacology components of multiple clinical programs, 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. May mentor scientific staff.

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.
• Responsible for implementing clinical pharmacology standard methodologies consistently.
• Responsible for 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.
• Leads 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.
• Responsible for collaborating with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies

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 in Clinical Pharmacology / PKPD or related field and 3 years of clinical pharmacology experience

Master’s degree in Clinical Pharmacology / PKPD or related field and 6 years of clinical pharmacology experience

Or

Bachelor’s degree in Clinical Pharmacology / PKPD or related field and 8 years of clinical pharmacology experience

And

Broad knowledge of leading and / or innovative principles and theories in field and basic knowledge of related and adjacent disciplinary areas.

And

Understands broader organizational goals and business priorities in relation to therapeutic program / work group.

Preferred Qualifications:

• PhD in Clinical Pharmacology / PKPD, PharmD with a clinical pharmacology fellowship, or equivalent degree in a related field with clinical pharmacology experience.
• 5-10 years of drug development experience with at least 5 years in clinical pharmacology
• Demonstrated success in managing clinical pharmacology activities and quantitative drug development (population PK, mechanistic PK/PD modeling/systems pharmacology, and clinical trial simulations). Experience in design, interpretation, implementation and reporting of phase I clinical pharmacology studies and packages to support regulatory submission. Understands interpretation and clinical application of other relevant scientific fields including drug metabolism, drug transport, formulation sciences, biopharmaceutics, and toxicology.
• Regulato