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About the Role
Amgen is seeking a Director, Clinical Pharmacology, Modeling & Simulation to lead the development and implementation of strategies for their innovative pipeline. This role involves applying advanced modeling and simulation techniques to ensure the optimal development of new drugs across various therapeutic areas.
Responsibilities
- Develop and implement Clinical Pharmacology, Modeling & Simulations strategies for the company's pipeline.
- Design strategic clinical pharmacology, modeling & simulations plans integrated with clinical development plans.
- Design clinical pharmacology and biopharmaceutic studies.
- Apply Model-Informed Drug Development (MIDD) strategies and principles of quantitative clinical pharmacology.
- Represent the Clinical Pharmacology, Modeling & Simulation Department at global cross-functional drug development teams.
- Apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies.
- Utilize Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, and Quantitative Systems Pharmacology (QSP) modeling.
- Ensure development of safe & effective dosing regimens for various patient sub-populations.
- Lead the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies.
- Integrate study results into regulatory filings and product labels.
- Interact with global health authorities.
- Author regulatory documents.
- Apply knowledge of global regulatory requirements and guidance.
Requirements
- Doctorate degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience.
- Master’s degree and 8 years of Clinical Pharmacology and Modeling & Simulation experience.
- Bachelor’s degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience.
- At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
- PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).
- 8+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
- Established track-record of designing strategic clinical pharmacology, modeling & simulations plans in support of new drug development across modalities.
- Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
- Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs.
- Expert knowledge of commonly used software for PBPK modeling required.
- Established track-record of Model Based Drug Development.
Skills
- Clinical Pharmacology
- Modeling and Simulation
- Model-Informed Drug Development (MIDD)
- Quantitative clinical pharmacology
- Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches
- Population PK/PD modeling
- Physiologically Based Pharmacokinetic (PBPK) modeling
- Quantitative Systems Pharmacology (QSP) modeling
- Biopharmaceutic studies
- Bioequivalence
- Bio-comparability
- Drug-drug interaction studies
- Special population studies
- Ethnic sensitivity studies
- ADME studies
- Pediatric studies
- Regulatory filings
- Product labels
- Interaction with global health authorities
- Authoring regulatory documents
- Global regulatory requirements and guidance
- PBPK modeling software
Location
- South San Francisco, CA
Work Type
- Full-time
Experience Level
- Director
- 4 years of Clinical Pharmacology and Modeling & Simulation experience
- 8 years of Clinical Pharmacology and Modeling & Simulation experience
- 10 years of Clinical Pharmacology and Modeling & Simulation experience
- 4 years of people management or leadership experience
- 8+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Education Level
- Doctorate degree
- Master’s degree
- Bachelor’s degree
- PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD)
Salary/Compensations
- 216,414.25 USD - 292,795.75 USD
Benefits
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan (for field sales representatives)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
About the Company
- Amgen's mission is to serve patients living with serious illnesses.
- Amgen pioneered the biotech industry in its fight against the world's toughest diseases.
- Amgen focuses on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease.
- 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.
- Amgen's award-winning culture is collaborative, innovative, and science-based.
- 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.
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, veteran status, disability status, or any other basis protected by applicable law.
- Individuals with disabilities will be 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.
- Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.