About the role

Aplyr's Quick Take

This role is about managing clinical pharmacology strategies for drug development at Amgen. You'll work with both local and global teams, focusing on optimizing pharmacology components and ensuring regulatory compliance. It's a managerial position that requires a mix of technical expertise and collaboration skills.

Good fit

Ideal candidates have at least 5 years in drug development, particularly in clinical pharmacology, and are comfortable navigating regulatory processes with PMDA. Strong communication skills in English and Japanese are essential, along with the ability to work independently and in teams.

Worth noting

The role emphasizes collaboration with global teams and requires familiarity with local regulatory documents, which might be a challenge for those without experience in Japan. The focus on specific disease areas like oncology or rare diseases may also limit the scope for generalists.

Career Category

Clinical

Job Description

■Job Summary

The Clinical Pharmacology Modeling & Simulation Manager will be responsible for developing and implementing clinical pharmacology strategies to support drug development programs. The successful candidate will be local representative of CPMS for the assigned programs, and provide clinical pharmacology expertise to global and local teams.

Key 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.

■Basic Qualifications

Knowledge/Skill
- 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.
Experience
- At least 5 years of drug development experience with expertise in clinical pharmacology
- Experiences in regulatory interaction with PMDA, such as PMDA consultations and inspections
- Experiences of collaboration with global teams
Education
- Master’s degree in pharmacology/pharmacokinetics or related scientific field

■Preferred Qualification

Strong knowledge/experience in a disease area(s) of focus for Amgen, e.g., Inflammation, Cardiometabolic, rare disease, and Oncology
PhD in pharmacology, pharmaceutical sciences, or a related field
Knowledge/experience of electronic data submission for population pharmacokinetic/exposure-response analyses.
Knowledge/experience of managing external venders

Aplyr's read

Amgen is a biotechnology leader focused on innovative therapeutics in oncology, cardiovascular, and inflammation, attracting professionals in science, engineering, and data analytics.
Synthesized from recent postings & public sources

What's promising

•Strong focus on cutting-edge biotechnology and human therapeutics.
•Diverse career opportunities in scientific, engineering, and data roles.
•Commitment to addressing serious health conditions like cancer and cardiovascular disease.

What to watch

•Highly competitive industry with constant innovation demands.
•Regulatory challenges in developing and marketing new therapies.
•Potential for high-pressure work environment due to ambitious goals.

Why Amgen

•Pioneering in biologic therapies with a focus on serious diseases.
•Robust pipeline of innovative drugs in various therapeutic areas.
•Global presence with a strong emphasis on research and development.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Amgen

Amgen

amgen.com

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AMGN$345.60+2.18%

Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. The company focuses on areas such as oncology, cardiovascular disease, and inflammation.