Role overview

Qualifications

Strong knowledge of ADME and pharmacodynamics.
At least 5 years of drug development experience with expertise in clinical pharmacology and regulatory interactions (PMDA).
Familiarity with local regulatory documents in CTNs, J-NDAs, and PMDA consultations.
Master's degree in pharmacology, pharmacokinetics, or a related scientific field.

Responsibilities

Optimize clinical pharmacology components in local drug development programs.
Collaborate with global and local cross-functional teams.
Apply clinical pharmacology principles and regulatory requirements to local drug development, including PMDA interactions.
Communicate clinical pharmacology results to internal and external stakeholders and contribute to regulatory submissions.

Key facts

Remote from: Japan
Full time
Senior (5-10 years)
English, Japanese

Hard skills

Pharmacodynamics Cross-Functional Collaboration Cardiology Medical Oncology Vendor Management Stakeholder Communications

Other skills

Communication
Collaboration
Teamwork

About the company

Horizon

Biotech: Biology + Technology

At Horizon Therapeutics, we believe science and compassion must work together to transform lives. We are driven to deliver innovative medicines to those living with rare, autoimmune and severe inflammatory diseases because we uniquely understand the patient journey. For us, success is measured by the numbers that matter most – the number of lives we touch, the number we change and those we work to help save.

Company details

Company typeLarge

IndustryBiotech: Biology + Technology

Company size1001 - 5000

Links

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Job description

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

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