Manager Clinical Pharmacology Modeling & Simulation Job at Amgen (Tokyo)

Director, Oncology Clinical Pharmacology Modeling and Simulation

At GSK, we have bold ambitions for patients, aiming to positively impact the hea...

Location

United States , Collegeville; Waltham; Durham

Salary:

188100.00 - 313500.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. PharmD or Master's degree in the same disciplines with an additional 4 years of relevant experience may be considered
5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling
and verifiable proficiency in pharmacometric tools NONMEM or R
3+ years of experience in planning, performing, and reporting model-based analysis of clinical data per industry and regulatory standards

Job Responsibility

Defining and executing model-based development strategies for oncology projects
Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Senior Manager - Clinical Pharmacology Modeling & Simulation

The successful candidate will contribute to Amgen’s multimodality development po...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 12 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
OR Bachelor’s degree and 15 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
Following skills are required: experience in people management and career development
good understanding of clinical pharmacology and pharmacokinetic/pharmacodynamic concepts
experience in conducting non-compartmental analysis
experience working with clinical pharmacology datasets and report writing
experience in working with Phoenix analysis software and with standardized SAS (ADaM) datasets
Familiar with the drug development process, regulatory guidelines (including Good Clinical Practices), analysis methodology, and clinical pharmacology studies
Skilled in using Microsoft Office software (ie, Word, Excel, PowerPoint)
Able to work under tight deadlines

Job Responsibility

Manage and train direct reports performing formal PK/PD data analysis, report writing, and quality control of clinical studies
Review analyses and outputs (ie, tables, figures, listings, and reports) of direct reports performing PK/PD data analyses on clinical studies to ensure accuracy and consistency in accordance with standard processes
Execution of formal PK/PD data analysis and report writing for clinical studies with a strong emphasis on quality and meeting timelines
Work closely with CPMS and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally
Contribute to Amgen’s multimodality development portfolio by conducting formal clinical pharmacology data analyses, summarizing pharmacokinetic/pharmacodynamic (PK/PD) data and results in clinical study report documents, performing quality control, reviewing PK/PD datasets, adhering to applicable regulatory guidance (ie, good clinical practices [GCP]), and providing oversight of clinical pharmacology data analysts performing similar tasks
Possess good written and oral communication skills, the ability to work well in teams, will demonstrate technical aptitude and a strong work ethic
Responsible for review and compliance with all applicable SOPs, business practices and company policies

Senior Manager, Pharmacometrics and Data Sciences

Cencora is seeking a Senior Manager, Pharmacometrics and Data Sciences to apply ...

Location

United States of America

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Pharm D or Ph.D. in Pharmaceutical Sciences or Biomedical Engineering, with specialization in pharmacometrics
A Master’s degree with substantial relevant experience will also be considered
3-5 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry
Demonstrated expertise in population PK/PD modeling, exposure-response analysis, and clinical trial simulations
Proficiency in pharmacometric software (essentially NONMEM and R, PKanalyx or Phoenix Winonlin)
Strong analytical and problem-solving skills
Good written and verbal communication skills
Organizational and project management skills
Knowledge of the pharmaceutical industry, including preclinical and early clinical development and the underlying pharmacometrics issues
Minimum knowledge of basic of IT

Job Responsibility

Development, execution and interpretation of pharmacometric analyses, including population PK and PK/PD models, Non-Compartmental Analysis (NCA), exposure-response modeling, clinical trial simulations
Develop and validate pharmacometric models to support dose selection, trial design, and decision-making
Analyze and interpret complex pharmacokinetic (PK) and pharmacodynamic (PD) data, integrating results with clinical and preclinical data
Author and review technical protocols, analysis plan, reports and scientific publications. Review regulatory documents in area of expertise
Propose innovative quantitative pharmacology approaches and optimize modeling processes
Collaborate with clinical pharmacology, biostatistics, regulatory, and clinical development teams to align pharmacometric strategies with program objectives
Communicate modeling results and their implications to cross-functional teams and senior management
Represent the company in meetings with academic institutions and industry forums as a pharmacometric subject matter expert
Oversee multiple pharmacometric projects, ensuring timely delivery of high-quality outputs
Ensure contact with the client

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs, employee resource groups, volunteer activities

Fulltime

New

Principal Scientist – Mathematical Modeling Lead/ Pharmacometric Modeling and Simulation

The department of clinical pharmacology, modeling and simulation seeks a motivat...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 8 years of clinical pharmacology experience OR Master’s degree and 12 years of clinical pharmacology experience
Degree in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD), and experience in the life sciences, Biotechnology and/or Pharmaceutical Industry, consulting or post-doctoral training
Demonstrated experience with scripting and implementing computational algorithms, optimization and model qualification methods, data analytics algorithms and models.
Hands on experience using a modeling software (e.g. Python, MATLAB, R, Julia, NONMEM, SAS, S-Plus, SQL, etc).
Excellent interpersonal, technical, and communication skills to lead cross-functional teams
Previous record of scientific contributions through peer-reviewed articles and external presentations
Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage

Job Responsibility

Independently developing and implementing analytics workflows to manage and analyse large, complex datasets from diverse sources, including real‑world data.
Driving innovation through the application of modern data architecture, data science engineering, data modeling, and advanced computing methodologies.
Planning and executing PK/PD analyses that integrate pharmacokinetics, pharmacodynamics, patient characteristics, and disease biology to optimize dose selection, dosing regimens, and study designs.
Mentoring and managing junior scientific staff to support modeling and simulation activities and collaborating closely with other modelers to implement data and modeling workflows for innovative pharmacometric projects.
Collaborating with cross‑functional partners, including observational research, health economics and outcomes research, statistics, and clinical biostatistics teams, to enable platform‑level analytics and modeling workflows.
Providing scientific thought leadership, guidance, and strategic input, and contributing to the external scientific community through publications and conference presentations.

AirCare ALS Paramedic, Ground Transport

The ALS Paramedic provides professional care through high-quality assessment, tr...

Location

United States , Winston-Salem

Salary:

24.10 - 36.15 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High school graduate or GED required
Successful completion of an accredited EMT-Paramedic training program required
North Carolina Paramedic certification required
BLS required
ACLS and PALS required to completing orientation
Two (2) years of clinical paramedic experience required - to include one (1) year of active field pre-hospital experience required
Advocate Health approved driving course to be completed within 90 days of hire
Must have a valid driver's license and qualify as insurable by Advocate Health insurance carrier requirements for driving AirCare vehicles

Job Responsibility

Provides professional care through high-quality assessment, triage / treatment to assess the nature and extent of a patient’s illness / injury and prioritize the needed care
Provides comprehensive care through skillful assessment, diagnosis, outcomes identification, planning, implementation, and evaluation
Must be proficient in advanced practice procedures to provide improved patient outcomes
Collects data pertinent to the healthcare consumer’s health or the situation
Analyzes the assessment data to determine the diagnosis or issues
Identifies expected outcomes for a plan individualized to the healthcare consumer or the situation
Develops a plan that prescribes strategies and alternatives to attain expected outcomes
Implements the identified plan, coordinates care delivery, and employs strategies to promote health and a safe environment
Evaluates progress toward attainment of outcomes
Practices ethically

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
$7,500 sign–on bonus (eligibility requirements apply)

Fulltime

AirCare ALS Paramedic - Ground Transports

The ALS Paramedic provides professional care through high-quality assessment, tr...

Location

United States , Winston Salem

Salary:

24.10 - 36.15 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High school graduate or GED required
Successful completion of an accredited EMT-Paramedic training program required
North Carolina Paramedic certification required
BLS required
ACLS and PALS required to completing orientation
Two (2) years of clinical paramedic experience required - to include one (1) year of active field pre-hospital experience required
Advocate Health approved driving course to be completed within 90 days of hire
Must have a valid driver's license and qualify as insurable by Advocate Health insurance carrier requirements for driving AirCare vehicles

Job Responsibility

Provides professional care through high-quality assessment, triage / treatment to assess the nature and extent of a patient’s illness / injury and prioritize the needed care
Provides comprehensive care through skillful assessment, diagnosis, outcomes identification, planning, implementation, and evaluation
Must be proficient in advanced practice procedures to provide improved patient outcomes
Collects data pertinent to the healthcare consumer’s health or the situation
Analyzes the assessment data to determine the diagnosis or issues
Identifies expected outcomes for a plan individualized to the healthcare consumer or the situation
Develops a plan that prescribes strategies and alternatives to attain expected outcomes
Implements the identified plan, coordinates care delivery, and employs strategies to promote health and a safe environment
Evaluates progress toward attainment of outcomes
Practices ethically

What we offer

Sign-on Bonus eligible and qualifies for a $7,500 sign–on bonus
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

New

Technical Project Manager

We are seeking a Technical Project Manager to join our Global Retail Engineering...

Location

Canada , Vancouver

Salary:

58.39 - 77.85 USD / Hour

Randstad

Expiration Date

July 26, 2026

Requirements

3+ years of project management experience in a fast-paced, dynamic environment, with a total of 5+ years in technology
Fluency in Spanish is mandatory to support the Mexico-based store openings
Strong understanding of complex IT systems and hardware delivery, specifically within a retail environment
Proven experience working with Vendor SOWs, RFPs, and contracts, and managing strategic 3rd party partners
PMP certification or formal knowledge of project management principles (Waterfall, Agile, or Hybrid)
Bachelor’s degree in a relevant field or an equivalent combination of experience
Knowledge of Coupa (or equivalent AP automation software) is highly desired

Job Responsibility

End-to-End Project Leadership: Own the project lifecycle for Mexico store rollouts, including requirements definition, schedule development, budget estimation, and implementation planning
Operational Readiness: Partner with engineers and architects to ensure all store technology (hardware and systems) is ready for cutover and launches without friction
Vendor & Procurement Management: Manage relationships with third-party vendors and resellers. This includes managing program ordering, cutting Purchase Orders (POs), and reconciling invoices using tools like Coupa
Stakeholder Coordination: Serve as the primary point of contact for business stakeholders, providing regular status updates and facilitating consensus across cross-functional teams
Risk & Scope Control: Establish processes for managing scope creep, setting performance standards, and identifying/mitigating risks before they impact the critical path
Financial Oversight: Manage the project budget strictly, ensuring all procurement activities align with budgetary guidelines and contractual obligations (SOWs, RFPs)

What we offer

Global Impact: Lead a high-visibility expansion for a major retail brand into the Mexican market
Technical & Financial Breadth: Gain experience managing both the deep technical cutover aspects of a store launch and the high-level financial procurement lifecycle
Collaborative Culture: Work in an in-person focused environment in Vancouver that values relationship building and cross-functional synergy
Professional Continuity: Lead a strategic NSO program from definition through to successful deployment

Fulltime

New

Technical Program Manager

We are seeking a high-initiative, vision-driven Technical Program Manager (TPM) ...

Location

Canada , Vancouver

Salary:

70.55 - 92.12 USD / Hour

Randstad

Expiration Date

July 24, 2026

Requirements

7+ years of experience managing complex, high-traffic web infrastructure programs at scale (E-commerce and Product Detail Page frameworks highly preferred)
A proven track record of successfully migrating engineering teams and applications from regional deployment structures to unified global systems
Clear, practical experience handling engineering labor budgets, vendor partnerships, PO lifecycles, and invoice reconciliation
Advanced expertise across program management systems, including Jira, Confluence, Miro, and the MS Office suite to drive meticulous organization
Bachelor's degree in Computer Science, Engineering, Business, or a related technical discipline

Job Responsibility

Scale Global Delivery: Lead, drive, and orchestrate large-scale, complex technical programs across multiple Web PDP engineering streams to establish a scalable global architecture
Proactive Blockade Management: Act as an independent engineering force to anticipate technical risks, expose critical path dependencies, and mitigate blockers proactively
High-Visibility Stakeholder Management: Navigate an expansive corporate landscape, building trust and communicating technical strategy, architectural roadmaps, and project health to senior executive leadership
Extreme Cross-Functional Collaboration: Foster cross-functional alignment across product management, engineering leads, and regional business units to secure uniform global success criteria
Resource Cost Optimization: Own financial tracking, variance analysis, and resourcing cost forecasting across your designated global engineering streams
Operational Procurement: Manage strategic vendor relationships, including Statement of Work (SOW) tracking, Purchase Order (PO) generation, and billing reconciliations to ensure continuous execution

What we offer

Massive Strategic Impact: Drive the global digital evolution of a premium, globally recognized activewear brand
High-Level Professional Exposure: Directly interface with and influence technical and business executive leadership teams
Technical Complexity: Lead multi-stream engineering efforts handling millions of global user interactions daily
Strong Potential for Longevity: Step into a 6-month contract with highly anticipated ongoing extensions within a rapidly growing program

Fulltime

Select Country

Manager Clinical Pharmacology Modeling & Simulation

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?