26 Oncology jobs in London

Clinical Research Scientist - Oncology

SW1A 0AA London, London £70000 Annually WhatJobs

Posted 17 days ago

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full-time
Our client , a leading biopharmaceutical company, is seeking a highly skilled and motivated Clinical Research Scientist to join their dynamic oncology research team in London . This hybrid role offers the opportunity to contribute to groundbreaking research aimed at developing novel therapies for cancer patients. You will be instrumental in designing, implementing, and overseeing clinical trials, working collaboratively with cross-functional teams.

As a Clinical Research Scientist, you will be responsible for the scientific integrity and execution of clinical studies. This involves protocol development, site selection, data analysis, and interpretation of results. You will play a key role in ensuring that trials are conducted in compliance with regulatory requirements, ethical standards, and company policies. Your expertise will be vital in advancing our understanding of cancer biology and translating scientific discoveries into clinical applications.

Key responsibilities include:
  • Developing and refining clinical trial protocols for oncology studies, ensuring scientific validity and feasibility.
  • Selecting and managing clinical trial sites, including investigator meetings and site initiation visits.
  • Overseeing data collection and monitoring the quality of data generated from clinical trials.
  • Performing statistical analysis and interpreting clinical trial data in collaboration with biostatisticians.
  • Preparing clinical study reports, manuscripts for publication, and regulatory submission documents.
  • Ensuring adherence to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements.
  • Collaborating with internal teams, including medical affairs, regulatory affairs, and drug development.
  • Presenting research findings at scientific conferences and internal meetings.
  • Providing scientific expertise and guidance to clinical development teams.

The ideal candidate will hold a Ph.D. or M.D. in a relevant life science or medical field, with a strong track record in oncology clinical research. A minimum of 5 years of experience in the pharmaceutical or biotechnology industry, managing clinical trials, is required. Comprehensive knowledge of cancer biology, clinical trial design, and regulatory landscapes is essential. Excellent analytical, communication, and leadership skills are necessary to effectively manage complex projects and collaborate with diverse teams. This is an exciting opportunity to contribute to innovative cancer research in London and make a significant impact on patient outcomes.
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Senior Clinical Research Scientist (Oncology)

SW1A 0AA London, London £65000 Annually WhatJobs

Posted 5 days ago

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full-time
Our client is seeking a highly motivated and experienced Senior Clinical Research Scientist specializing in Oncology to join their dynamic team in **London, England, UK**. This role offers a unique opportunity to contribute to cutting-edge pharmaceutical research and development. You will be instrumental in designing, implementing, and overseeing clinical trials, ensuring adherence to regulatory standards and ethical guidelines.

Responsibilities:
  • Lead the scientific aspects of oncology clinical trials, from protocol development to final report generation.
  • Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and project management, to ensure trial success.
  • Analyze complex clinical data, interpret results, and prepare comprehensive reports and presentations for internal stakeholders and regulatory bodies.
  • Stay abreast of the latest scientific advancements, competitor activities, and regulatory changes in the oncology field.
  • Mentor and guide junior research scientists, fostering a collaborative and innovative research environment.
  • Contribute to the strategic planning of the oncology pipeline, identifying new research opportunities and therapeutic targets.
  • Ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other relevant regulations.
  • Manage relationships with external investigators, research sites, and key opinion leaders.
Qualifications:
  • PhD or Master's degree in a relevant scientific discipline (e.g., Biology, Biochemistry, Pharmacology, Oncology).
  • Minimum of 5-7 years of experience in clinical research within the pharmaceutical industry, with a strong focus on oncology.
  • Demonstrated expertise in oncology drug development, clinical trial design, and statistical analysis.
  • Excellent understanding of regulatory requirements (FDA, EMA) and ethical considerations in clinical research.
  • Proven ability to manage multiple projects simultaneously, meet deadlines, and deliver high-quality results.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Exceptional communication, interpersonal, and presentation skills.
  • Ability to work effectively in a fast-paced, team-oriented environment.
This is an exciting opportunity to make a significant impact in the fight against cancer. The role requires a blend of scientific rigor, strategic thinking, and leadership capabilities.
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Lead Clinical Research Associate - Oncology

SW1A 0AA London, London £65000 Annually WhatJobs

Posted 11 days ago

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full-time
Our client, a pioneering pharmaceutical company at the forefront of medical innovation, is seeking an experienced Lead Clinical Research Associate (CRA) to oversee critical oncology clinical trials. This is a field-based role, requiring significant travel to trial sites across the UK and potentially internationally.

As a Lead CRA, you will be responsible for ensuring the quality, integrity, and efficiency of clinical trials conducted in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements. You will lead a team of CRAs, provide mentorship, and act as the primary point of contact for investigational sites. Your expertise in oncology drug development and trial management will be essential.

Key Responsibilities:
  • Lead and manage a team of CRAs, providing training, mentorship, and performance management.
  • Oversee the planning, execution, and monitoring of multiple clinical trials in oncology.
  • Ensure compliance with study protocols, GCP, FDA, EMA, and other relevant regulatory guidelines.
  • Conduct site selection, initiation, monitoring, and close-out visits.
  • Build and maintain strong relationships with principal investigators, site staff, and other stakeholders.
  • Review and approve site-generated documentation, including source documents, case report forms (CRFs), and regulatory binders.
  • Identify and resolve site-level issues and deviations promptly.
  • Contribute to the development of clinical trial protocols, Investigator's Brochures, and other essential documents.
  • Manage study budgets and timelines, ensuring efficient resource allocation.
  • Prepare and present trial progress reports to internal and external stakeholders.
  • Stay updated on the latest developments in oncology research and clinical trial methodologies.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
  • Minimum of 6-8 years of experience as a Clinical Research Associate, with at least 2 years in a lead or supervisory role.
  • Extensive experience in oncology clinical trials is mandatory.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
  • Proven experience in site management, monitoring, and auditing.
  • Excellent leadership, communication, interpersonal, and problem-solving skills.
  • Ability to travel extensively (up to 60-70%) as required by the role.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Strong organizational skills and attention to detail.

This demanding role is based in **London, England, UK**. If you are a seasoned leader in clinical research with a passion for oncology and a commitment to driving scientific advancement, we encourage you to apply.
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Senior Clinical Research Associate - Oncology

WC2N 5DU London, London £70000 Annually WhatJobs

Posted 12 days ago

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full-time
Our client, a leading innovator in pharmaceutical research and development, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This role is critical in advancing groundbreaking oncology treatments and offers a unique opportunity to contribute to life-saving therapies. As a Senior CRA, you will be responsible for overseeing and managing all aspects of clinical trial conduct, ensuring compliance with protocols, regulations, and ethical standards. You will conduct site visits, including initiation, monitoring, and close-out visits, to assess the quality and integrity of trial data and ensure patient safety. This involves verifying source data, reviewing case report forms (CRFs), and resolving data queries promptly. You will also play a key role in site selection and qualification, building strong relationships with investigators and site staff to facilitate efficient trial execution. Furthermore, you will be involved in protocol development input, site training, and the preparation of regulatory submissions. Your expertise will be invaluable in identifying and mitigating potential risks, ensuring timely recruitment, and maintaining accurate and comprehensive trial documentation. This is a fully remote position, providing you with the flexibility to work from anywhere within the UK. You will collaborate closely with cross-functional teams, including medical affairs, regulatory affairs, and project management, to ensure seamless trial operations. The ideal candidate will possess a deep understanding of GCP, ICH guidelines, and relevant regulatory requirements. A proactive approach, excellent problem-solving skills, and exceptional communication abilities are essential for success in this role. We are looking for individuals who are passionate about making a difference in patient care through cutting-edge pharmaceutical research. If you are a seasoned CRA looking for a challenging and rewarding remote opportunity in the pharmaceutical sector, we encourage you to apply. This role offers competitive compensation, comprehensive benefits, and the chance to work on impactful clinical trials that will shape the future of cancer treatment. Join us in our mission to bring hope and healing to patients worldwide.
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Lead Clinical Research Scientist - Oncology

SW1A 0AA London, London £75000 annum + ben WhatJobs

Posted 15 days ago

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full-time
Our client, a pioneering pharmaceutical company, is actively seeking a highly motivated and experienced Lead Clinical Research Scientist to join their dedicated oncology research team in London, England, UK . This critical role will involve leading and contributing to the design, development, and execution of innovative clinical trials aimed at discovering and advancing novel cancer therapies. The ideal candidate will possess a strong scientific background, extensive knowledge of oncology drug development, and a proven ability to manage complex research projects from inception through to regulatory submission. You will collaborate closely with cross-functional teams, including R&D, regulatory affairs, and clinical operations, to drive research initiatives forward and contribute to the company's pipeline of life-saving medicines.

Key Responsibilities:
  • Lead the scientific strategy and development of oncology clinical trial protocols.
  • Oversee the execution of clinical studies, ensuring adherence to scientific integrity, GCP, and regulatory guidelines.
  • Analyse and interpret clinical data, drawing conclusions and making recommendations for further development.
  • Author clinical study reports, scientific publications, and regulatory submission documents.
  • Provide scientific expertise and guidance to internal teams and external investigators.
  • Stay abreast of the latest scientific advancements, competitive landscape, and regulatory changes in oncology.
  • Collaborate with project teams to ensure timely and successful completion of clinical development milestones.
  • Contribute to the identification and evaluation of new drug targets and therapeutic approaches.
  • Mentor and guide junior members of the clinical research team.

The successful candidate will hold a PhD or MD in a relevant scientific discipline, coupled with significant experience in clinical research within the pharmaceutical industry, specifically in oncology. Demonstrated leadership skills and a track record of successfully managing complex clinical trials are essential. Strong analytical, problem-solving, and written/verbal communication skills are required. Familiarity with drug development processes, regulatory requirements (e.g., FDA, EMA), and Good Clinical Practice (GCP) is paramount. This is an exceptional opportunity to play a leading role in the advancement of cancer treatment at a globally respected pharmaceutical organisation based in the vibrant city of London .
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Principal Clinical Research Scientist - Oncology

SW1A 0AA London, London £75000 Annually WhatJobs

Posted 21 days ago

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full-time
Our client, a globally recognised pharmaceutical innovator, is seeking a distinguished Principal Clinical Research Scientist to spearhead critical research initiatives within the oncology therapeutic area. This pivotal role will involve designing, implementing, and overseeing complex clinical trials aimed at developing life-saving treatments. The successful candidate will be a subject matter expert in oncology drug development, with a profound understanding of clinical trial methodologies, regulatory requirements, and data analysis. This position offers a unique opportunity to influence the future of cancer treatment, working within a collaborative and scientifically rigorous environment. The role is based in London, England, UK , and will operate on a hybrid basis, combining strategic remote work with essential in-office collaboration.

Key Responsibilities:
  • Lead the scientific strategy and design of Phase I-IV clinical trials for novel oncology therapies.
  • Provide expert scientific and clinical input into protocol development, amendments, and clinical study reports.
  • Oversee the interpretation of clinical data, ensuring accuracy and scientific integrity.
  • Collaborate closely with internal teams (e.g., Regulatory Affairs, Medical Affairs, Biostatistics) and external partners (e.g., investigators, key opinion leaders, CROs).
  • Contribute to the preparation of regulatory submissions and scientific publications.
  • Stay abreast of the latest advancements in oncology, relevant scientific literature, and competitive landscape.
  • Provide scientific leadership and mentorship to junior research staff and study teams.
  • Ensure all clinical research activities are conducted in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company SOPs.
  • Participate in scientific conferences and represent the company at relevant medical and scientific meetings.
  • Drive innovation in clinical trial design and execution to accelerate drug development.
Qualifications:
  • PhD or MD in a relevant scientific or medical discipline.
  • Extensive experience (minimum 8-10 years) in clinical development, with a focus on oncology.
  • Deep understanding of oncology drug mechanisms, disease pathology, and therapeutic strategies.
  • Proven experience in designing and managing complex clinical trials.
  • Excellent knowledge of clinical trial methodology, statistical principles, and data analysis.
  • Strong understanding of global regulatory requirements (e.g., FDA, EMA).
  • Exceptional scientific writing and presentation skills.
  • Demonstrated leadership capabilities and the ability to influence cross-functional teams.
  • Experience working within a pharmaceutical or biotechnology company.
  • Ability to work effectively in both remote and in-office settings.
This role requires a visionary scientist who is passionate about transforming patient care through groundbreaking research. If you are a leader in oncology clinical development and are looking to make a significant impact, we invite you to explore this exciting opportunity.
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Senior Clinical Research Scientist - Oncology

SW1A 0AA London, London £85000 Annually WhatJobs

Posted 21 days ago

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full-time
Our client, a globally recognised pharmaceutical innovator, is seeking a highly motivated and experienced Senior Clinical Research Scientist to join their cutting-edge oncology drug development team. This is a fully remote position, allowing you to contribute to life-saving research from **London, England, UK**, or any other location. You will play a crucial role in the design, execution, and interpretation of clinical trials, focusing on novel oncology therapeutics. Your responsibilities will include developing clinical trial protocols, overseeing study conduct, analysing complex data sets, and contributing to regulatory submissions. You will collaborate closely with internal stakeholders, including R&D, regulatory affairs, and medical affairs, as well as external partners such as investigators, key opinion leaders, and contract research organisations (CROs). The ideal candidate will possess a strong scientific background, extensive experience in clinical oncology research, and a deep understanding of drug development processes and regulatory requirements. You will be adept at critical data evaluation, scientific writing, and presenting complex information clearly and concisely. This role requires a proactive, detail-oriented individual with excellent problem-solving skills and the ability to manage multiple projects simultaneously. We are looking for a strategic thinker who can contribute to the scientific direction of our oncology pipeline. A PhD or MD in a relevant scientific discipline (e.g., oncology, pharmacology, molecular biology) is preferred, along with a minimum of 5-7 years of experience in clinical trial design and management within the pharmaceutical industry or a related research setting. Experience with immuno-oncology and targeted therapies is highly desirable. This is an exceptional opportunity to make a significant impact on the lives of cancer patients worldwide, working within a collaborative and innovative research environment. Join us and be at the forefront of oncology drug development.

Responsibilities:
  • Design and develop clinical trial protocols for oncology indications.
  • Oversee and manage the conduct of clinical trials.
  • Analyse and interpret clinical trial data.
  • Prepare scientific reports, publications, and regulatory documents.
  • Collaborate with cross-functional teams and external partners.
  • Provide scientific expertise on oncology drug development.
  • Stay abreast of scientific literature and industry trends.
  • Contribute to regulatory submissions and interactions.
  • Mentor junior research staff.
  • Evaluate new research opportunities and technologies.
Qualifications:
  • PhD or MD in a relevant scientific field.
  • 5-7+ years of experience in clinical oncology research.
  • Strong understanding of drug development and regulatory processes.
  • Expertise in clinical trial design and execution.
  • Excellent data analysis and interpretation skills.
  • Proficiency in scientific writing and presentation.
  • Experience with immuno-oncology or targeted therapies.
  • Ability to work independently and manage projects.
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Medical Director, Clinical Development - Hematology/Oncology

Uxbridge, London Gilead Sciences, Inc.

Posted 13 days ago

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally, the Medical Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.
**Responsibilities**
+ Provide medical monitoring to multiple hematology/oncology clinical trials
+ Lead project/study teams to design and implement hematology/oncology clinical studies
+ Write protocols, investigator brochures, clinical study reports and review clinical trial documents
+ Conduct investigator meetings and lead site initiation visits with clinical trial investigators
+ Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
+ Translate findings from research and nonclinical studies into clinical development opportunities
+ Interact with clinical investigators and thought leaders
+ Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
+ Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner.
+ Work in a cross-functional team environment, including with clinical operations, biomarker specialists, CROs, and regulatory affairs
+ Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
+ Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
**Requirements:**
+ MD/DO degree and clinical development experience in the pharmaceutical industry.
+ Board certification/specialization in Hematology or Oncology and experience managing oncology trials.
+ CAR-T therapeutic area experience (preferred)
+ Multiple myeloma disease area expertise (required)
+ Phase 2 or 3 study experience within the pharmaceutical industry.
+ Relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
+ Demonstrated clinical development strategist with experience designing, implementing, and conducting clinical trials, with emphasis on late-stage clinical development.
+ Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
+ Strategic leadership and tactical skills, excellent initiative, and judgment
+ Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
+ Demonstrated ability to work well in teams in a cross functional manner
+ Ability to communicate and work in a self-guided manner with scientific/technical personnel
+ Ability to think critically, and demonstrated troubleshooting and problem-solving skills
+ Self-motivated and willing to accept temporary responsibilities outside of initial job description
+ Comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
+ May travel up to 25%
+ Must be based in Stockley Park Gilead Office
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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Clinical Research Associate (CRA) - Oncology

SW1A 0AA London, London £55000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client is a leading global pharmaceutical company dedicated to advancing cancer treatments. They are seeking a highly skilled and experienced Clinical Research Associate (CRA) specializing in Oncology to join their dynamic team. This role, based in the vibrant hub of London, England, UK , offers an exciting opportunity to contribute to critical oncology clinical trials, ensuring data integrity, patient safety, and adherence to regulatory guidelines. You will be a key player in bringing life-saving therapies to patients.

Responsibilities:
  • Monitor clinical trial sites to ensure compliance with protocol, SOPs, GCP, and regulatory requirements.
  • Perform site initiation, interim, and close-out monitoring visits.
  • Verify accuracy and completeness of clinical data through source data verification (SDV).
  • Identify, evaluate, and recommend potential investigators and study sites.
  • Manage study site relationships, providing training and ongoing support to investigators and study staff.
  • Ensure timely submission of required documentation and reports.
  • Track study progress, identify risks, and implement corrective actions to ensure milestones are met.
  • Manage investigational product accountability and drug reconciliation.
  • Oversee patient recruitment and retention efforts at study sites.
  • Prepare monitoring visit reports and communicate findings and recommendations to study teams and sites.
  • Ensure all regulatory and ethical guidelines are followed throughout the trial lifecycle.
  • Participate in study team meetings and contribute to protocol development where applicable.
  • Maintain effective communication with internal and external stakeholders.
  • Manage site budgets and payments as required.
  • Contribute to the development of monitoring plans and risk-based monitoring strategies.
  • Ensure timely resolution of data queries and discrepancies.
  • Uphold the highest standards of patient safety and data integrity.
  • Stay current with advancements in oncology research and clinical trial methodology.
  • Contribute to the training and mentoring of junior CRAs.
Qualifications:
  • Bachelor's degree in a life science, nursing, pharmacy, or related discipline. An advanced degree is a plus.
  • Minimum of 3-5 years of independent clinical monitoring experience, with a strong emphasis on oncology trials.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
  • Proven ability to conduct site visits, review data, and ensure compliance.
  • Excellent understanding of oncology disease states and treatment paradigms.
  • Strong analytical and problem-solving skills.
  • Exceptional written and verbal communication abilities.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel frequently (up to 60%) within the UK and potentially internationally.
  • Strong organizational skills and the ability to manage multiple priorities effectively.
  • A professional and proactive attitude with a commitment to quality.
  • Ability to work independently and as part of a cross-functional team.
  • Experience with rare disease or early-phase oncology trials is an advantage.
This is a demanding but highly rewarding role for a dedicated professional. We offer a competitive salary, comprehensive benefits, and the opportunity to be at the forefront of cancer research.
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Senior Manager Clinical Study Lead (Oncology)

Uxbridge, London Regeneron Pharmaceuticals

Posted 10 days ago

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The **Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.
_This role is not eligible fully remote. This role is required to be onsite in one of our locations._
**A typical day in this role looks like:**
+ Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
+ Provides operational input into protocol development
+ Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
+ Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
+ Ensures compliance with the clinical trial registry requirements
+ Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
+ Provides input into baseline budget development and management
+ Provides input into baseline timeline development and management
+ Leads risk assessment and identifies risk mitigation strategies at the study level
+ Leads the feasibility assessment to select relevant regions and countries for the study
+ Oversees/conducts site evaluation and selection
+ Leads investigator meeting preparation and execution
+ Monitors progress for site activation and monitoring visits and acts on any deviations from plan
+ Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
+ Monitors data entry and query resolution and acts on any deviations from agreed metrics
+ Ensures accurate budget management and scope changes for internal and external studies
+ Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
+ Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
+ Oversees the execution of the clinical study against planned timelines, deliverables and budget
+ Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
+ Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
+ Ensure clinical project audit and inspection readiness through the study lifecycle
+ Supports internal audit and external inspection activities and contributes to CAPAs as required
+ Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
+ Contributes to clinical study report writing and review
+ Facilitates and contributes to study level lessons learned
+ Assigns tasks to Clinical Study Management staff and supports their deliverables
+ Recommends and participates in cross-functional and departmental process improvement initiatives
+ Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
+ May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
+ Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
+ May require 25% travel
**This role may be for you if you have:**
+ Exceptional interpersonal & leadership skills
+ Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
+ Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
+ Advanced communication skills via verbal, written and presentation abilities
+ Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
+ Ability to influence and negotiate across a wide range of stakeholders
+ Strong budget management experience
+ An awareness of relevant industry trends
+ Ability to build, lead and develop productive study teams and collaborations
+ Applies advanced negotiation and interpersonal skills to vendor management
+ Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
+ Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
+ Knowledge of ICH/GCP and regulatory guidelines/directives
+ Advanced project management skills, cross-functional team leadership and organizational skills
+ Line management experience
**In order to be considered qualified,** a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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  48. perm_media Media & PR
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  50. local_hospital Military & Public Safety
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  52. medical_services Nursing
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  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
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  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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