Amgen Principal Scientist - Clinical Pharmacology, Modeling & Simulation in South San Francisco, California
Principal Scientist - Clinical Pharmacology
Biotechnology opened the door to new types of medicines based on nature’s own building blocks. Amgen has played a huge role in advancing this revolution and the company’s broad toolkit of drug modalities just got larger https://www.amgenpipeline.com/pipeline/ . The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a leader of Clinical Pharmacology: Principal Scientist-Clinical Pharmacology for its South San Francisco, CA location. This position reports to the Director of Clinical Pharmacology, Modeling & Simulation. The Principal Scientist of Clinical Pharmacology will be responsible for the development and implementation of the Clinical Pharmacology and Modeling Simulation strategies for cutting edge novel modalities including Bi-specific T-cell engagers, antibody-drug-conjugates, CAR-T cells, oncolytic viruses based immunotherapies in addition to small molecule & mono-clonal antibodies. The Principal Scientist will be a member of cross-functional global drug development teams as the Clinical Pharmacology, Modeling &Simulation department representative & will be Subject Matter Expert who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development. The Principal Scientist will also be responsible for designing integrated Clinical Pharmacology, Modeling & Simulation plans & designing, planning and execution of clinical pharmacology studies in support of these plans.
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+ 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.
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.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.