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About the Role

The Clinical Pharmacology Modeling & Simulation Manager will develop and implement clinical pharmacology strategies to support drug development programs. This role serves as the local representative for CPMS on assigned programs, providing clinical pharmacology expertise to global and local teams.

Responsibilities

• Optimize clinical pharmacology components in local drug developments.
• Collaborate with global and local cross-functional teams.
• Apply clinical pharmacology principles and regulatory requirements to local drug development.
• Effectively communicate clinical pharmacology results to internal and external stakeholders.
• Contribute to regulatory submissions and interactions with PMDA.

Requirements

• At least 5 years of drug development experience with expertise in clinical pharmacology.
• Experience in regulatory interaction with PMDA, such as PMDA consultations and inspections.
• Experience of collaboration with global teams.

Skills

• Strong knowledge of ADME and pharmacodynamics.
• Familiarity with local regulatory documents in CTNs, J-NDAs, PMDA consultations.
• Excellent communication and collaboration skills in both English and Japanese.
• Ability to work independently and as part of a team.
• Strong knowledge/experience in a disease area(s) of focus for Amgen, e.g., Inflammation, Cardiometabolic, rare disease, and Oncology.
• Knowledge/experience of electronic data submission for population pharmacokinetic/exposure-response analyses.
• Knowledge/experience of managing external vendors.

Experience Level

• At least 5 years of drug development experience

Education Level

• Master’s degree in pharmacology/pharmacokinetics or related scientific field
• PhD in pharmacology, pharmaceutical sciences, or a related field

About the Company

• Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
• This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
• Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
• A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
• For more information, visit www.amgen.com and follow us on www.twitter.com/amgen