Amgen Principal Scientist - Clinical Pharmacology, Modeling & Simulation in Thousand Oaks, California
In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world.
As the Principal Scientist - Clinical Pharmacology, Modeling & Simulation you will be responsible for clinical pharmacology components of multiple clinical programs, including study design, protocol preparation, and reporting. You will be able to integrates results into regulatory filings and product labels and understand 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.
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 best practices consistently.
Responsible for planning and execution 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 interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies.
May mentor scientific staff.
Doctorate degree and 3 years of clinical pharmacology experience
Master’s degree and 6 years of clinical pharmacology experience
Bachelor’s degree and 8 years of clinical pharmacology experience
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.
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, execution, and reporting of phase I clinical pharmacology studies and packages to support regulatory submission. Understands interpretation and clinical application of other relevant scientific disciplines including drug metabolism, drug transport, formulation sciences, biopharmaceutics, and toxicology.
Scientific Excellence: Demonstrated track record of published literature in clinical pharmacology. Demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for drug development.
Communication Skills: Demonstrated ability to effectively present clinical pharmacology data, development plans, and strategies to various audiences in both verbal and written form. Demonstrated ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents / interactions.
Considerable organizational awareness (inter-relationship of departments, business priorities, etc.).
Ability to travel locally and globally.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.