Director, Clinical Research Scientist Oncology Job at Proclinical (Wilmington)

Clinical Scientist Director - Late Development Oncology

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

Portugal , Lisbon

Salary:

105822.45 - 143171.55 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
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
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models including remote and hybrid work arrangements where possible

Fulltime

Clinical Scientist Director - Late Development Oncology

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

Portugal , Lisbon

Salary:

105822.45 - 143171.55 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience OR Master's degree and 7 years of life sciences/healthcare experience OR Bachelor's degree and 9 years of life sciences/healthcare experience

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

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
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Clinical Scientist Director - Late Development Oncology

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

Spain

Salary:

131166.90 - 177461.10 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

A 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
Flexible work models, including remote and hybrid work arrangements, where possible

Clinical Scientist Director – Early Development, Oncology

In this vital role, the Clinical Scientist Director will support early phase cli...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Industry or academic experience in early-phase drug development within Oncology
Strong communication & presentation skills in English
Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
Serving as a contributing author to scientific publications and data presentations at scientific conferences

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Clinical Scientist Associate Director – Late Development, Oncology

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

Portugal , Lisbon

Salary:

79656.90 - 107771.10 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master's degree and 5 years of life sciences/healthcare experience
Bachelor's degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into and implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

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
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Clinical Scientist Associate Director - Late Development, Oncology

In this role, the Clinical Scientist Associate Director supports late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience
3 years of pharmaceutical clinical drug development experience
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
Strong communication and presentation skills in English
Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Clinical Scientist Director, Late Development GU Oncology

In this vital role, the Clinical Scientist Director will support late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Industry experience in late-phase drug development for oncology (prostate-specific experience is a plus)
Strong communication & presentation skills
Experience with designing, monitoring, and implementing clinical trials for oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities
Experience drafting high level submission documents for regulatory submissions
Serving as a contributing author to scientific publications and data presentations at scientific conferences

Job Responsibility

Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials
Serve as a key clinical development team member
Provide hands-on oversight of protocol execution, medical data review, and clinical data quality
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data
Present information internally and externally
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs)
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites
Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Partner with SCP and the study team to define and support recruitment initiatives at site level

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

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Director, Clinical Research Scientist Oncology

Job Description

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