Clinical Safety Scientist Job at SRG (London)

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

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...

Location

Spain

Salary:

90787.65 - 122830.35 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 the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders

Fulltime

Senior Clinical Scientist

Drive the science behind life‑changing rare disease studies with rigor, insight,...

Location

United States , Boston

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in life sciences or healthcare
advanced degrees (PhD, MD, PharmD, MSc) preferred
Experience in pharmaceutical clinical drug development, with a focus on CNS, rare diseases, or cardio-metabolism preferred
Solid knowledge of clinical research regulatory requirements (e.g., GCP, ICH)
Strong analytical skills to interpret clinical trial data and synthesize conclusions
Ability to manage multiple priorities with effective planning and time management
Proficient in designing and executing clinical research studies and authoring related documents
Strong problem-solving, conflict resolution, and critical thinking skills
Excellent communication, technical writing, and presentation abilities

Job Responsibility

Participate in program team meetings, scientific advisory boards, study steering committees, and data-safety monitoring meetings
Represent the clinical function in collaborative activities with other departments
Maintain a thorough understanding of therapeutic disease areas, drug candidates, and clinical practices, ensuring compliance with FDA, EMEA, ICH, and GCP guidelines
Propose, design, and execute clinical research studies for early- and late-stage assets, supported by scientific literature
Collaborate with medical writing teams to author and review clinical trial protocols, amendments, and other trial-related documents
Lead the preparation of materials for external stakeholder meetings, including investigator meetings, governance discussions, and regulatory authority presentations
Conduct clinical and medical data reviews, including safety monitoring, to ensure patient safety
Identify risks in program objectives and design mitigation strategies
Promote consistent clinical data review techniques across studies and programs

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

Oncology Late Stage Clinical Scientist

You will be responsible for scientific oversight, data integrity and quality of ...

Location

United States , Collegeville; La Jolla; Cambridge; Bothell; Groton

Salary:

139100.00 - 225100.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO
MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO
BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval
Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
Experience working on large data sets
Proficiency with Microsoft Office and relevant scientific software
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
Experience leveraging a variety of communication tools and techniques to communicate results

Job Responsibility

Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program
Responsible for scientific oversight, data integrity and quality of the clinical trial(s)
Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
supports preparations for Health Authority meetings, participates as appropriate
Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends
reviews and queries data
presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s)

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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

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

Oncology Late Stage Clinical Scientist

You will be responsible for scientific oversight, data integrity and quality of ...

Location

United States , Collegeville; La Jolla; Cambridge; Bothell; Groton

Salary:

139100.00 - 225100.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO
MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO
BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval
Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
Experience working on large data sets
Proficiency with Microsoft Office and relevant scientific software
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
Experience leveraging a variety of communication tools and techniques to communicate results

Job Responsibility

Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program
Responsible for scientific oversight, data integrity and quality of the clinical trial(s)
Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
supports preparations for Health Authority meetings, participates as appropriate
Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends
reviews and queries data
presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s)

What we offer

Bonus target of 17.5% 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

Fulltime

Senior Pre-Clinical Scientist within Analytical Chemistry

As one of our pre-clinical chemical analysis scientists, you will become one of ...

Location

Denmark , Humlebæk

Salary:

Not provided

Coloplast

Expiration Date

Until further notice

Requirements

Have a master’s degree or higher with a solid knowledge of organic- and analytical chemistry as well as a broad background in chemistry in general
Have a broad knowledge and hand-on experience within methods and equipment’s within the analytical chemical field
Have experience working with screening extractables and leachable within ISO 10993
Have a good understanding of sample preparation techniques
Speak and write English fluently
Have a drive to understand complex chemical problems

Job Responsibility

Become one of our experts in analytical chemistry, supporting projects with your chemical competences
Developing and optimizing new analytical methods
Helping us understand how our products perform
Work on a diverse range of products within wound-, ostomy- and continence care
Bring your important chemical knowledge to various cross-functional projects
Rethink and help solve unexpected challenges
Collaborate closely with cross-functional teams to translate clinical needs into robust analytical chemical protocols
Contribute to the scientific foundation of our innovation projects
Help guide product development
Ensure that our chemical test strategies are aligned with clinical applications

Fulltime

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Clinical Safety Scientist

Job Responsibility

Requirements

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