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

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

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

Scientist, Quantitative Clinical Pharmacology (PK/PD Modeling & Simulation)

Join Hemab, a clinical-stage biotech company, on an exciting journey to build th...

Location

Denmark , Copenhagen

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Applied Mathematics, Statistics, or related field
with 1–3 years of relevant experience
Hands-on experience with population PK/PD modeling software (NONMEM, Monolix, Phoenix NLME) and programming languages (R, MATLAB)
Strong understanding of PK/PD principles, biologics drug development, and model-informed drug development strategies
Experience in one or more of the following areas is preferred: biologics PK/PD, rare disease development, translational modeling, or target-mediated drug disposition (TMDD)
Familiarity with quantitative systems pharmacology (QSP) approaches is a plus

Job Responsibility

Develop, validate, and execute population PK, PK/PD exposure–response, PBPK and QSP models to support dose selection, regimen optimization, and trial design
Perform simulations to inform early clinical study design, establish clinical proof-of-concept (PoC), and guide pivotal program decisions
Analyze preclinical and clinical PK/PD data, translating insights into actionable recommendations for clinical teams
Contribute quantitative components for regulatory submissions (INDs, CTAs, BLAs) and respond to agency questions on modeling and simulation deliverables
Collaborate cross-functionally to ensure modeling insights are integrated into development plans and communicated clearly to stakeholders
Stay current with regulatory expectations, industry trends, and new quantitative methods to continuously improve modeling strategies and workflows
Support vendor and consultant selection and management to ensure high-quality, timely deliverables for modeling and simulation activities
Be a proactive and collaborative team player, receptive to constructive feedback and committed to meeting program goals

Fulltime

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.

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

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

Vice President

iCapital is looking to hire an investment product specialist Vice President to s...

Location

China , Hong Kong

Salary:

Not provided

iCapital Network

Expiration Date

Until further notice

Requirements

10+ years of experience working within the alternative investment industry in a client facing capacity (e.g., Investor relations at GPs or distribution specialist at placement agents, fund of funds and asset management firms with alternative investment product experience)
A self-starter who demonstrates the ability to work in a fast-paced entrepreneurial environment and follow a rigorous sales process
Strong team orientation with exceptional organizational and interpersonal skills especially in a cross-boarder and small team-working environment
Strong with Microsoft powerpoint and has excellent verbal and written communication skills
Local regulatory licensing is required
Relevant language skills is a plus

Job Responsibility

Leverage a consultative sales process to acquire new relationships, expand existing client relationships, and service assets under management
Develop high level of sales proficiency with iDirect offerings in private equity, private credit, and hedge funds and other future iDirect products and a good understanding of the asset class as well as product comparison purposes
Traveling is required to markets to meet with gatekeepers, advisors, industry bodies, end clients in support of the broader sales and educational effort
Assist in the planning and execution of roadshows and conferences
Work alongside the in region Client Solutions team personnel on client pitches, product positioning, and sales campaigns
Leverage technology input and reporting tools to support sales management activities

Fulltime

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Manager Clinical Pharmacology Modeling & Simulation

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