Director, Clinical Scientist Job at Kailera Therapeutics (Waltham)

Director, Clinical Scientist

The Director, Clinical Scientist plays a key role in supporting the clinical dev...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings
Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
autoimmune disease experience highly desirable
Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
Proven ability to author and critically review clinical protocols, study reports, and regulatory documents
Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
Exceptional scientific judgment, attention to detail, and analytical rigor
Strong communication and collaboration skills
Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.

Job Responsibility

Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development
Lead or contribute to the preparation of key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables

What we offer

health and retirement
PTO
stock option plans

Fulltime

Director, Clinical Scientist

The Director, Clinical Scientist plays a key role in supporting the clinical dev...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development
Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
autoimmune disease experience highly desirable
Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
Exceptional scientific judgment, attention to detail, and analytical rigor
Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.

Job Responsibility

Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development
Lead or contribute to the preparation of key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables
Maintain awareness of emerging scientific and regulatory trends in cell and gene therapy and autoimmune diseases to integrate innovations into development strategy

What we offer

health and retirement
PTO
stock option plans

New

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

New

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

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 - Late Development, Rare Disease

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
Strong preference for individuals with proven track record of clinical trial process improvement
Industry or academic experience in late-phase drug development for the Rare Disease therapeutic area
Strong communication & presentation skills in English
Experience with designing, monitoring, and implementing clinical trials for the Rare Disease therapeutic area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, data base 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

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

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

Clinical Scientist Director, Late Development- Inflammation

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

Location

United States

Salary:

229458.00 - 273757.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of clinical development experience
Master’s degree and 7 years of clinical development experience
Bachelor’s degree and 9 years of clinical development experience
5 years of pharmaceutical clinical drug development experience
Industry or academic experience in late-phase drug development for Inflammation Development Therapeutic Area
Experience with designing, monitoring, and implementing clinical trials for the Inflammation Development Therapeutic Area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, data base 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
Experience in clinical data analysis such as Spotfire or other data analysis tools

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
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
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
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
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
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams

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 where possible

Fulltime

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Director, Clinical Scientist

Job Description

Job Responsibility

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What we offer

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