Study Director Job at Argenta (Shawnee, Kansas)

Study Director

Argenta is seeking a Study Director to join our Americas CRO leadership team. Th...

Location

United States , Shawnee, Kansas

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Advanced degree in a scientific discipline
10+ years experience in animal health product development, or veterinary clinical study project management
Proven experience managing cross functional teams
Thorough knowledge of practical experience in GLP protocols, Final Study Reports and Study Master Files
Collaborative working style and the ability to lead and motivate people at all levels and across multiple functions within the organization
Proven affinity with Animal Health
Excellent attention to detail and scientific judgement

Job Responsibility

Approve and sign study protocol
Ensure objectives meet regulatory requirements
Coordinate with Sponsors and Quality Assurance
Delegates tasks accordingly during the course of the study but retails full responsibility
Ensures the study follows GLP and study protocol, overseeing animal care, sample collection and data recording
Addresses deviations and ensures proper documentation
Review and interpret results ensuring the scientific validity of conclusions
Writes, approves and signs the final study report
Ensures all raw data are archived properly

Fulltime

Junior Study Director – Extractables & Leachables (E&L)

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree with ~5 years of experience
Master's degree with ~2-3 years of experience
PhD in a relevant scientific field
Background in Chemistry, Analytical Sciences, or related discipline
Knowledge or exposure to analytical techniques (LC-MS, GC-MS, ICP-MS)
Interest in regulated environments (medical devices, pharmaceuticals)
Strong team spirit and good communication skills
Fluent in English (French is a plus)

Job Responsibility

Support the design and execution of E&L studies with internal teams and external laboratories
Contribute to protocol writing, data analysis, and reporting
Ensure alignment with industry standards (ISO 10993-18, USP <1663/1664>)
Collaborate with cross-functional teams (analytical chemistry, toxicology, regulatory, manufacturing)
Participate in compound identification and data interpretation
Support scientific investigations and continuous improvement initiatives
Ensure compliance with quality and regulatory requirements

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Junior Study Director – Extractables & Leachables (E&L)

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree with ~5 years of experience
Master's degree with ~2-3 years of experience
PhD in a relevant scientific field
Background in Chemistry, Analytical Sciences, or related discipline
Knowledge or exposure to analytical techniques (LC-MS, GC-MS, ICP-MS)
Interest in regulated environments (medical devices, pharmaceuticals)
Strong team spirit and good communication skills
Fluent in English

Job Responsibility

Support the design and execution of E&L studies with internal teams and external laboratories
Contribute to protocol writing, data analysis, and reporting
Ensure alignment with industry standards (ISO 10993-18, USP <1663/1664>)
Collaborate with cross-functional teams (analytical chemistry, toxicology, regulatory, manufacturing)
Participate in compound identification and data interpretation
Support scientific investigations and continuous improvement initiatives
Ensure compliance with quality and regulatory requirements

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Junior Study Director – Extractables & Leachables (E&L)

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree with ~5 years of experience
Master's degree with ~2-3 years of experience
PhD in a relevant scientific field
Background in Chemistry, Analytical Sciences, or related discipline
Knowledge or exposure to analytical techniques (LC-MS, GC-MS, ICP-MS)
Interest in regulated environments (medical devices, pharmaceuticals)
Strong team spirit and good communication skills
Fluent in English

Job Responsibility

Support the design and execution of E&L studies with internal teams and external laboratories
Contribute to protocol writing, data analysis, and reporting
Ensure alignment with industry standards (ISO 10993-18, USP <1663/1664>)
Collaborate with cross-functional teams (analytical chemistry, toxicology, regulatory, manufacturing)
Participate in compound identification and data interpretation
Support scientific investigations and continuous improvement initiatives
Ensure compliance with quality and regulatory requirements

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Study Director - Extractables & Leachables

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or Master’s degree with 5–7 years, or PhD with 3+ years of experience in a related field
Demonstrated experience in Extractables & Leachables studies
Strong background in analytical method development and validation
Solid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP‑MS
Experience with chemical characterization standards for medical devices and container closure systems
Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging
Strong scientific judgment and critical thinking
Ability to lead complex studies with autonomy and rigor
Excellent communication and collaboration skills
Comfortable working in cross‑functional, multicultural teams

Job Responsibility

Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging
Author and review study protocols, reports, and technical documentation, incorporating input from subject matter experts
Lead method development, validation, and transfer activities in collaboration with internal teams and external laboratories
Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations
Ensure scientific justification of study designs and results to support innovative and compliant products
Review and interpret E&L data, identifying trends and correlations with materials of construction
Drive the structural identification of extractables and leachables
Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments
Work cross‑functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners
Participate in regulatory interactions, including submissions, pre‑submission meetings, and responses to authority questions

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Study Director - Extractables & Leachables (E&L)

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or Master's degree with 5–7 years, or PhD with 3+ years of experience in a related field
Demonstrated experience in Extractables & Leachables studies
Strong background in analytical method development and validation
Solid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP-MS
Experience with chemical characterization standards for medical devices and container closure systems
Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging
Strong scientific judgment and critical thinking
Ability to lead complex studies with autonomy and rigor
Excellent communication and collaboration skills
Comfortable working in cross-functional, multicultural teams

Job Responsibility

Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging
Author and review study protocols, reports, and technical documentation
Lead method development, validation, and transfer activities
Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations
Ensure scientific justification of study designs and results
Review and interpret E&L data, identifying trends and correlations
Drive the structural identification of extractables and leachables
Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments
Work cross-functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners
Participate in regulatory interactions

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Director study start-up

Ensure world-class study start-up planning and execution by leading teams, stren...

Location

United States

Salary:

206344.00 - 238674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Doctorate degree & 4 years of clinical execution experience or equivalent OR Master’s degree & 8 years of clinical execution experience or equivalent OR Bachelor’s degree & 10 years of clinical execution experience or equivalent
Minimum of 4 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead and inspire the Study Start-Up Management team to deliver high-quality study start-up activities with speed, efficiency, and budget discipline
Provide strategic direction and people leadership to SSU Senior Managers
Drive continuous improvement through leadership of the SSU Hub
Oversee SSU operating model performance
Ensure strong SSU management capability through targeted development of skills, processes, systems, and technology expertise
Lead SSU manager resource planning and forecasting
Foster a culture of empowerment, collaboration, and open communication
Build strong partnerships with global and cross-functional stakeholders

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director Study Start-up

Drive world-class study start-up planning and execution across a global portfoli...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Minimum of 3 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Must meet one of the following education/experience combinations: Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience

Job Responsibility

Lead and manage a team of Study Start-up Managers
Drive end-to-end study start-up planning and execution from global to local
Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics
Build team capability through coaching, mentoring, performance management
Partner with functional and hub leaders to strengthen study start-up capabilities
Own and embed study start-up business processes
Foster a collaborative, high-engagement culture
Contribute to the evolution of the Study Start-up Hub model

What we offer

Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

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Study Director

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Study Director

Study Director

Junior Study Director – Extractables & Leachables (E&L)

Junior Study Director – Extractables & Leachables (E&L)

Junior Study Director – Extractables & Leachables (E&L)

Study Director - Extractables & Leachables

Study Director - Extractables & Leachables (E&L)

Director study start-up

Associate Director Study Start-up

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