Career CategoryScientific
Job DescriptionPrincipal Scientist - Clinical Pharmacology Modeling and SimulationWhat you will doLet's do this. Let's change the world. In 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.
What we expect of youWe 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
Master's degree and 5 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
OR
Bachelor's 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.
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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range147,696.00USD -199,824.00 USD
