Clinical pharmacology manager Job at Randstad (Shanghai)

Director, Clinical Pharmacology

We are seeking a motivated Director, Clinical Pharmacology, to join our growing ...

Location

United States

Salary:

230000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science
5+ years of direct industry experience in conducting clinical stage drug development
Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents
Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics
Fluency in model-informed drug development
Experience working with external CROs
Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools)
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation
Ability to work in cross-functional teams within a highly dynamic environment
Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities
Influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum
Develop and help implement quantitative approaches to drug development programs
Work in close collaboration with different functions
Lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners
Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise
Support pediatric development, including protocol development and dose selection
Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting
Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Clinical Data Analyst

AB Science is hiring a Clinical Data Analyst based in Paris. Responsibilities co...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management
Knowledge of clinical development process
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Job Responsibility

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan
Ensure Clinical Data Management input to other relevant strategic study documents and vendor contracts
Detect important medical events
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database
Detect the forbidden concomitant treatments as per study protocol
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team
Archive documents in the clinical data management TMF

What we offer

Permanent position
Salary & package to define according skills and experience

Fulltime

Director, Clinical Pharmacology

As a Director of Clinical Pharmacology, you will be responsible for planning, ma...

Location

Denmark

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD or equivalent in Clinical Pharmacology, Pharmacometrics, or a related field
Minimum of 6 years of experience in clinical pharmacology and pharmacometrics within the pharmaceutical or biotechnology industry
Prior experience managing/leading program level clinical pharmacology deliverables at a Biopharma or Biotech is highly preferred. Alternatively, experience working at CROs leading clinical pharmacology and/or pharmacometrics workflows for biologics development is also considered
Demonstrated expertise in analyzing/interpreting clinical pharmacology endpoints (PK, PD data) and using them for designing PK-PD modeling and pharmacometrics modules to achieve clinical PoC
Strong background in pharmacokinetic and pharmacodynamic principles, with hands-on experience in study design, data analysis, and interpretation
Prior working experience closely with clinical development, biostats and regulatory teams towards regulatory filings is highly preferred
Prior experience managing clinical pharmacology CROs/consultants is preferred
DMPK (Drug Metabolism and Pharmacokinetics) expertise and bioanalytical experience are preferred and would be valuable additions to the role
Experience with immunogenicity assessments for biologics is preferred
Awareness of Nonclinical PK and toxicokinetic (TK) assessment for regulatory filings is preferred but not a must

Job Responsibility

Primarily spearhead and execute the clinical pharmacology strategy beginning in pre-phase 1/2 and through pivotal studies and approvals
Contribute as clinical pharmacology lead for establishing clinical proof-of-concept (PoC), dosing recommendations, clinical study design/execution documents and regulatory filings by working cross-functionally primarily with clinical development, clinical operations, regulatory and quality teams
Lead PK-PD modeling and pharmacometrics workflows and manage related vendors/consultants for timely deliverables
Design and oversee pharmacokinetic and pharmacodynamic studies to support dose selection, safety assessments, and efficacy evaluations
Evaluate, select and manage CROs/consultants that meet the specific program's needs and timelines
Maintain excellent relationships built on transparent and effective communications with external stakeholders
Keep abreast with current regulatory and industry practices in clinical pharmacology for biologics development
Provide clinical pharmacology expertise for regulatory interactions and submissions, including IND, NDA/BLA filings
Be a dedicated team player and flexible with constructive feedback from other functional leads unique to each program goals and challenges
Excellent program management skills combined with a strong scientific mindset

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

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

PK Scientist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills
1+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements
Working knowledge of data analyses software packages
Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis (Experience with R is an advantage)
Basic knowledge of noncompartmental PK analysis and statistical principles
Understanding of clinical trial data structures and experience collaborating with Data Management, Biostatistics, and CRO partners

Job Responsibility

Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance
Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods
Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA
Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs)
Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...

Location

United States , Cambridge; La Jolla; Bothell; Groton; New York City

Salary:

176600.00 - 282900.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
MS and a minimum of 7 years of experience in a similar role in industry/CRO
BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
Experience in or strong understanding of Oncology Drug Development especially in Early Development
Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Strong scientific writing skills and communication skills (written and verbal)
Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance

Job Responsibility

Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Support execution for all FIH programs through proof-of concept
Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
review and query data
present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials

What we offer

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Clinical pharmacology manager

Randstad

Location:
China , Shanghai

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 26, 2026

Expiration:
June 03, 2026

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Clinical pharmacology manager

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Location:China , Shanghai

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Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 26, 2026

Expiration:June 03, 2026

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March 26, 2026

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