Principal Scientist Clinical Pharmacology Modeling and Simulation

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions.

As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the this vital role you will develop and execute integrated clinical pharmacology and model-informed drug development strategies that inform dose and regimen selection clinical study design regulatory filings and product labeling.

You will work closely with colleagues across clinical development pharmacometrics biostatistics nonclinical development bioanalytical sciences regulatory affairs and other functions to translate emerging data into clear and actionable drug-development decisions.

Key Responsibilities

• Serve as the clinical pharmacology lead for one or more development programs providing scientific and strategic leadership from early clinical development through registration and post-approval development.
• Develop integrated clinical pharmacology plans addressing key program questions related to PK PD exposure-response dose and regimen selection drug-drug interactions intrinsic and extrinsic factors special populations ethnic sensitivity formulation changes/biopharmaceutics.
• Design oversee and plan timing for clinical pharmacology components of development programs including first-in-human (FIH) drug-drug interaction ADME organ impairment BA/BE pediatrics and other dedicated clinical pharmacology studies.
• Lead clinical pharmacology strategy for FIH starting dose and escalation decisions by integrating nonclinical pharmacology toxicology PK/PD target engagement translational biomarkers and predicted human exposure.
• Contribute to analysis of preclinical PK/PD data for FIH dose selection.
• Plan interpret and present on noncompartmental population PK and exposure-response analyses (and other quantitative analyses as appropriate) to support program decisions study design Ph1-3 dose selection and regulatory submissions.
• Contribute clinical pharmacology expertise to clinical development plans protocols study reports IBs regulatory briefing documents health authority meetings INDs NDA/BLA/MAA and product labeling.
• Contribute to interactions with global health authorities including the preparation review and resolution of clinical pharmacology questions and regulatory information requests.
• Provide scientific oversight and review of modeling & simulation plans evaluation of assumptions/methods interpretation of results and communication of conclusions to teams and governance bodies.
• Collaborate closely with pharmacometricians statisticians clinicians bioanalytical scientists toxicology/safety scientists and regulatory colleagues to ensure timely and high-quality execution of clinical pharmacology deliverables.
• Can communicate complex quantitative and clinical pharmacology concepts clearly and influence program strategy through scientifically rigorous data-driven recommendations.
• Influences external scientific environment through publications presentations and participation in professional organizations as appropriate.

We are all different yet we all use our unique contributions to serve patients. The clinical pharmacology professional we seek is a collaborative Scientific leader with these qualifications.

Basic Qualifications:

Doctorate degree PhD

OR

PharmD

OR

MD and relevant post-doc where applicable and 2 years of clinical pharmacology pharmacometrics modeling and simulation or related drug-development experience

OR

Masters degree and 5 years of clinical pharmacology pharmacometrics modeling and simulation or related drug-development experience

OR

Bachelors degree and 7 years of clinical pharmacology pharmacometrics modeling and simulation or related drug-development experience

Preferred Qualifications:

• PhD PharmD MD or equivalent advanced degree in Pharmaceutical Sciences or Pharmacology Chemical Engineering or related quantitative discipline.
• 5 years of experience in Clinical Pharmacology Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Demonstrated experience developing and executing clinical pharmacology strategies across drug development including dose and regimen selection study design ER assessment and regulatory support.
• Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on population PK PK/PD modeling PBPK modeling and QSP modeling to inform development decisions.
• Experience designing overseeing and interpreting clinical pharmacology studies including first-in-human DDI food-effect ADME special population BA/BE or bridging studies.
• Established track record of contributing to regulatory submissions health-authority interactions responses to regulatory questions and product labeling.
• Strong scientific judgment leadership through influence cross-functional collaboration and written and verbal communication skills.
• A record of scientific accomplishment demonstrated through successful program contributions regulatory impact publications presentations or other evidence of external scientific influence.

As 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 well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship for this role is not guaranteed.

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.

Salary Range