Clinical Pharmacology Modeling & Simulation Sr. Scientist

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 patients around the world.

As the Senior Scientist you will be responsible for clinical pharmacology components of multiple clinical programs, including study design, protocol preparation, and reporting. Integrates results into regulatory filings and product labels. Understands 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.

Job Responsibilities

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

Basic Qualifications

Doctorate degree and 2 years of Clinical Pharmacology experience

OR

Master's degree and 5 years of Clinical Pharmacology experience

OR

Bachelor's degree and 7 years of Clinical Pharmacology experience

Preferred Qualifications

• A PhD in Clinical Pharmacology / PKPD, PharmD with a clinical pharmacology fellowship, or equivalent degree in a related field with clinical pharmacology experience.
• 3+ years of drug development experience with at least 3 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, bio-pharmaceutics, and toxicology.
• Scientific Excellence: Proven 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.
• Interpersonal Skills: Proven ability to effectively present clinical pharmacology data, development plans, and strategies to audiences in both verbal and written form. Proven 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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.