Amgen
Principal Scientist - Clinical Pharmacology Modeling and Simulation
US - California - Thousand Oaks · Principal
Sponsorship not specifiedDetected 6 hours ago
PharmacologyFDA RegulatoryResearchExperimental DesignAnimal StudiesLeadershipCommunicationCollaborationPublic SpeakingBiostatisticsRegulatory Affairs
About the role
- 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.
- 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.
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.
- 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.
- 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.
- 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.
Requirements
- Doctorate degree PhD
- MD [and relevant post-doc where applicable] and 2 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
- Master's degree and 5 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
- Bachelor's degree and 7 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
Nice to have
- 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.
- 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.
- 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.
- Award-winning time-off plans
- What you can expect of us
Compensation
- 147,696.00USD -199,824.00 USD
Benefits
- 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.
Company info
- 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.
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.