Manager Clinical Pharmacology Modeling & Simulation
Amgen Inc. has closed or removed this posting -- see current similar openings below.
About this opportunity
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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Job details
How this role compares
Computed from every other active Clinical Development role in our database, not just this employer's listings.
We currently track 330 comparable Manager Clinical Development roles across 63 biopharma companies.
Salary context
94 of 330 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 330 comparable roles
+ 21 more countries
Seniority mix
330 of 330 peers have a known seniority level
Therapeutic area mix
38 of 330 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Currently open similar roles
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.