63 Clinical Trials jobs in the United Kingdom
Assoc Dir/Director, Regulatory Affairs
Posted 4 days ago
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Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.
To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
ESSENTIAL JOB FUNCTIONS:
The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.
To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions.
- Contribute to the development and implementation of regulatory strategies for assigned projects.
- Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.). Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.
- Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.
- Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.
- Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).
- Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.
- Provides strategic and technical regulatory input for key product development documents.
- Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.
JOB SPECIFICATIONS:
- Minimum 8+ for Associate Director, and 10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience
- PharmD/MS preferred, or Bachelors degree in life science
- Experience supporting NDAs and working on post-approval products, drug labeling experience would be great
- Experience leading IND/CTA submissions for clinical trials
- Excellent written and spoken communication skills
- Strong organizational skills
- Strong interpersonal skills
- Solid working knowledge of drug development process
- Experience with planning and managing IND/CTA submissions.
- Experience working and interacting directly with FDA and/or other agencies
- Good understanding of US and EU regulatory landscape
- Hematology/Oncology or orphan-drug experience are preferred
- Demonstrated ability to think critically and analyze scientific information while paying close attention to detail
- The ability to influence and negotiate professionally at various levels within the project team and with external partners
The base range for this role at the Associate Director level is $172,521 - $02,540 and Director level is 216,799 - 249,862 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
#LI-RM1
Kura’s Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date ofNovember 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -mutant and KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at and follow us onX andLinkedIn .
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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#J-18808-LjbffrClinical Trials Manager
Posted 4 days ago
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Job Title: Clinical Trials Manager
Location: London
Contract: 5 months
Hours: 14.5 hours per week (9-5 Mondays/Tuesday)
Rates: 22.79-23.97 p/h
Job Description
SRG are looking for a clinical trials manager to join a leading higher educations provider based in London. The primary role of the post holder is to set up and support a high quality clinical trial at the CCTU.
Duties and Responsibilities
- To establish and maintain effective management systems for the trial
- To act as the central Trials Unit contact for the Trial
- To work closely with the Chief Investigator, trial and IT staff to ensure the successful management of the Trial.
- Secure all necessary approvals for the trial and participating sites according to the UK regulations including UK Research Governance Framework
- Coordinate the design, printing and distribution of trial documentation
- Develop trial specific documentation that is compliant with the CCTU Policies and Standard Operating Procedures (SOPs) and ensure this is implemented and kept up to date.
- Ensure sites have appropriate training and maintain necessary records.
- Work within budget constraints in liaison with the Project Manager.
- Ensure that good communication is maintained between the CCTU and recruiting centre staff
- Provide updates on the progress of the trial at regular Trial Management Group meetings, to the Independent Data Monitoring and Trial Steering Committees and to the funder as required.
- Monitor the trial sites to assess compliance with the protocol and regulatory requirements.
- Prepare under the guidance of the Clinical Project Manager, the trial specifications for the Database.
- Undertake Risk Assessment of the trial and, with the Clinical Project Manager, propose appropriate mitigations.
- Minute trial related meetings.
- Supervise the data collected and enter data if required.
- Supervise the data cleaning and validation, including querying and chasing missing data in a timely manner.
- Monitor trial recruitment, providing support and motivation to recruiting staff as required.
- Ensure the timely submission and processing of data and documents from sites to the CTU including safety events. Prepare and submit the necessary reports to appropriate regulatory, ethical and other parties (such as submission of safety reports to the Ethics Committee).
- Represent the trial at conferences, meetings and internal unit meetings as appropriate.
- Keep the relevant literature searches up to date.
- Participate in university and the CCTU training and development initiatives.
- Carry out any other comparable tasks as required including being prepared to assist those working on other studies/trials as directed by the Head of Clinical Trial Operations.
Experience and Qualifications
- Degree and/or equivalent experience in Clinical Trials
- Experience of managing a clinical trial
- Experience of managing a trial of an investigational medicinal product
- Comprehensive understanding of UK Clinical Trials Regulations, ICH Good Clinical Practice, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health's Research Governance Framework
- Experience of monitoring
- Experience of using Pharmacovigilance systems
- Experience of working in an academic or similar institution
- Experience of public speaking and giving presentations
- Experience of data management
- Evidence of ability to set up and maintain effective management system in trials
- Excellent IT skills; MS Office Suite, Trial Databases and other Trial related systems (such as IMP management, Randomisation)
- Excellent communication and interpersonal skills
- A methodical and accurate approach to work with attention to detail
- The ability to make and carry out decisions and know when to confer with colleagues or refer matters onwards
- The ability to work without direct supervision; to manage own workload and display good organisational ability
- Take responsibility for setting and meeting targets for your own work and others
- Ability to evaluate risks inherent in clinical trials and decide those which should be prioritised to ensure that risks are properly managed
- Advanced organisational skills, managing several projects that are often time pressured, concurrently
- Ability to supervise other members of the team, promote good working relationships and resolve difficult situations
- Commitment to and knowledge of advancing equality, diversity and inclusion
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Statistical Genetics Lead - Clinical Trials
Posted today
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Your new company
A leading biotech company, with a well-established presence in multiple therapy areas is looking to hire a Lead Statistical Genetics Scientist to support the further development of their products.They have a track record of innovation and a highly collaborative, cross-functional work environment.You would be joining an established team with significant expertise within genetics an.
WHJS1_UKTJ
Principal Statistician (Bayesian clinical trials)
Posted 10 days ago
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Job Description
Salary : Principal Statistician: £55£62k (depending on experience)
Contract : Permanent
Hours : Full time 37.5 hours per week
Start : As soon as possible
Closing date: When filled
The Intensive Care National Audit & Research Centre (ICNARC) is an independent, not-for-profit, scientific organisation. Our work helps improve the quality of critical c.
Clinical Research Coordinator
Posted 1 day ago
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Job Description
Are you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator.
This part-time role is to support a site in Halifax, West Yorkshire in conducting a clinical trial for 15 hours per week.
As a pivotal member of the site team, you will be involved with a variety of administrative tasks to support investigators and ensure the smooth running of clinical trials and assist with collecting patient data.
Day to day responsibilities will include:
- Support clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
- Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns
- Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
- Plan and coordinate logistical activity for study procedures according to the study protocol
- Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
- Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
- Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
- Correct custody of study drug according to site standard operating procedures
- Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions.
We are looking for candidates with the following skills and experience:
- BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting, e.g. clinical research coordinator, nurse, medical assistant, other medical profession
- Basic knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Basic knowledge of medical terminology
- Strong IT competence, skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
- Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and client
- Good organizational skills with the ability to pay close attention to detail.
Clinical Research Coordinator
Posted 1 day ago
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Job Description
Are you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator.
This part-time role is to support a site in Oldham in conducting a clinical trial for 16 hours per week.
As a pivotal member of the site team, you will be involved with a variety of administrative tasks to support investigators and ensure the smooth running of clinical trials and assist with collecting patient data.
Day to day responsibilities will include:
- Support clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
- Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns
- Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
- Plan and coordinate logistical activity for study procedures according to the study protocol
- Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
- Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
- Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
- Correct custody of study drug according to site standard operating procedures
- Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions.
We are looking for candidates with the following skills and experience:
- BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting, e.g. clinical research coordinator, nurse, medical assistant, other medical profession
- Basic knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Basic knowledge of medical terminology
- Strong IT competence, skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
- Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and client
- Good organizational skills with the ability to pay close attention to detail.
Clinical Research Coordinator
Posted 1 day ago
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Job Description
Job Title: Clinical Research Coordinator (Band 6 Nurse)
Contract Type: Part-Time (2–3 days/week)
Overview:
We are seeking a skilled and motivated Band 6 Nurse to support clinical research activities as a Clinical Research Coordinator. This part-time role offers an excellent opportunity to contribute to impactful research while maintaining a flexible schedule.
Key Responsibilities:
- Identify and recruit eligible patients for clinical trials.
- Perform accurate and timely data entry into study databases.
- Collaborate with research and clinical teams to ensure protocol compliance.
- Maintain high standards of documentation and regulatory adherence.
Requirements:
- Registered Band 6 Nurse with relevant clinical experience.
- Demonstrated experience in patient identification and data entry.
- Strong attention to detail and organizational skills.
- Must be available to work every Wednesday, plus two additional weekdays.
Please submit your CV or get in touch via email:
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Clinical Research Physician
Posted 8 days ago
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Job Description
Our client, an innovative clinical research organisation (CRO) is currently looking for a Clinical Research Physician to join their team in London.
As a Clinical Research Physician, you will spearhead early stage clinical trials, manage study protocols and ensure ethical conduct and compliance at all stages. You will collaborate with an expert sponsor team and contribute to ground-breaking projects that advance healthcare and improve patient outcomes.
You will be driven to enhance patient safety, improve quality systems and ensure the data produced for the development of individual drugs is of the highest standard.
This role will offer tremendous scope for leadership and personal development. With this site being relatively new, this person will have the remit to grow and nurture a clinical research team around them as well as having significant involvement and influence with their sponsors.
Key Responsibilities
- Provide medical direction, oversee protocol compliance and ensure participant safety throughout clinical trials.
- Evaluate and interpret clinical data, performing necessary assessments to maintain data accuracy and integrity.
- Collaborate on scientific feasibility for new inquiries, assisting sponsors and guiding clinical operations teams as needed.
- Ensure adherence to regulatory requirements and Good Clinical Practice standards, maintaining rigorous documentation and participant confidentiality.
Requirements
- A medical degree (MD) - essential
- Full and current GMC registration - essential.
- Strong background in clinical research / clinical trials.
- Proven experience as a Clinical Research Physician.
- Strong knowledge of regulatory guidelines.
- Excellent organisational, communication and analytical skills.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.
Clinical Research Physician
Posted 8 days ago
Job Viewed
Job Description
Our client, an innovative clinical research organisation (CRO) is currently looking for a Clinical Research Physician to join their team in London.
As a Clinical Research Physician, you will spearhead early stage clinical trials, manage study protocols and ensure ethical conduct and compliance at all stages. You will collaborate with an expert sponsor team and contribute to ground-breaking projects that advance healthcare and improve patient outcomes.
You will be driven to enhance patient safety, improve quality systems and ensure the data produced for the development of individual drugs is of the highest standard.
This role will offer tremendous scope for leadership and personal development. With this site being relatively new, this person will have the remit to grow and nurture a clinical research team around them as well as having significant involvement and influence with their sponsors.
Key Responsibilities
- Provide medical direction, oversee protocol compliance and ensure participant safety throughout clinical trials.
- Evaluate and interpret clinical data, performing necessary assessments to maintain data accuracy and integrity.
- Collaborate on scientific feasibility for new inquiries, assisting sponsors and guiding clinical operations teams as needed.
- Ensure adherence to regulatory requirements and Good Clinical Practice standards, maintaining rigorous documentation and participant confidentiality.
Requirements
- A medical degree (MD) - essential
- Full and current GMC registration - essential.
- Strong background in clinical research / clinical trials.
- Proven experience as a Clinical Research Physician.
- Strong knowledge of regulatory guidelines.
- Excellent organisational, communication and analytical skills.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.
Clinical Research Physician
Posted 11 days ago
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Job Description