Amgen
Clinical Pharmacology Modeling and Simulation - Senior Principal Scientist
Amgen, Thousand Oaks, California, United States, 91362
Clinical Pharmacology Modeling and Simulation - Senior Principal Scientist
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.What you will doLet'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. You will possess an 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. You may mentor scientific staff.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 to 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.Contributes 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 the 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.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications.Basic Qualifications:Doctorate degree in Clinical Pharmacology / PKPD or related field and 3 years of clinical pharmacology experience ORMasters degree in Clinical Pharmacology / PKPD or related field and 6 years of clinical pharmacology experience ORBachelors degree in Clinical Pharmacology / PKPD or related field and 8 years of clinical pharmacology experienceAND Broad knowledge of leading and/or innovative principles and theories in the field and basic knowledge of related and adjacent disciplinary areas.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.Regulatory Knowledge: Experience in interactions with regulatory agencies. Understands, and is able to apply, appropriate FDA and ICH guidelines in the design of clinical development plans and studies.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.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.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:A 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.Flexible work models, including remote and hybrid work arrangements, where possible.Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.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.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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.
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At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.What you will doLet'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. You will possess an 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. You may mentor scientific staff.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 to 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.Contributes 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 the 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.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications.Basic Qualifications:Doctorate degree in Clinical Pharmacology / PKPD or related field and 3 years of clinical pharmacology experience ORMasters degree in Clinical Pharmacology / PKPD or related field and 6 years of clinical pharmacology experience ORBachelors degree in Clinical Pharmacology / PKPD or related field and 8 years of clinical pharmacology experienceAND Broad knowledge of leading and/or innovative principles and theories in the field and basic knowledge of related and adjacent disciplinary areas.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.Regulatory Knowledge: Experience in interactions with regulatory agencies. Understands, and is able to apply, appropriate FDA and ICH guidelines in the design of clinical development plans and studies.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.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.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:A 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.Flexible work models, including remote and hybrid work arrangements, where possible.Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.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.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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.
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