Clinical Trials Director

4 days ago


New York, New York, United States Daiichi Sankyo, Inc. Full time
Job Title: Clinical Trials Director

About Daiichi Sankyo, Inc.
Daiichi Sankyo Group is a global pharmaceutical innovator dedicated to improving standards of care and addressing unmet medical needs. With over 125 years of scientific expertise, we have a rich legacy of innovation and a robust pipeline of promising new medicines.

Job Summary:
The Clinical Trials Director will provide strategic direction and planning for clinical trial execution, ensuring regulatory compliance and cross-functional cohesiveness. This role involves overseeing the development of SOPs, maintaining awareness of updates, and coordinating implementation across functions.

Responsibilities:
- Develop and maintain an overview of Development SOP landscape, including planned new documents, changes, and retirements.
- Create awareness of SOP updates resulting from organizational changes, regulatory requirements, CAPAs, cross-functional initiatives, and routine process updates.
- Identify, escalate, and plan mitigations related to potential systemic gaps in the Development SOP landscape and/or processes.
- Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee.

Requirements:
- Bachelor's Degree with at least 10 years of experience in pharmaceutical or biotechnology development functions or clinical quality assurance.
- Strong understanding of GCPs and applicable global regulatory guidelines governing clinical trials preferred.
- Experience with end-to-end clinical trial processes and functions, including one or more Development functions preferred.

Salary: $120,000 - $160,000 per year

About the Role:
This is a critical position that requires strong leadership and project management skills, as well as the ability to influence others without direct authority. The ideal candidate will have experience working with Quality Management systems, process improvement methodologies, and global health authority inspections.

  • New York, New York, United States Lifelancer Full time

    We are looking for a highly motivated and experienced Clinical Trials Operations Director to join our team at Alnylam Pharmaceuticals. As a key member of our Clinical Operations department, you will be responsible for driving global study start-up and site activation activities.With a strong background in clinical operations and significant experience in...


  • New York, New York, United States Lifelancer Full time

    At Lifelancer, we are seeking an experienced Senior Biostatistics Director, Clinical Trials to join our team of dedicated professionals in the pharmaceutical industry. Our company is committed to discovering, creating, testing, and delivering transformative medicines to treat patients suffering from genetic diseases and cancers with clear genetic drivers.We...


  • New York, New York, United States Lexeo Therapeutics Full time

    About the JobLexo Therapeutics invites applications for a Director/Senior Director, Clinical Statistician position, focusing on leading biostatistical activities for a complex portfolio of gene therapy studies and other projects.This role requires strong collaboration with cross-functional partners to meet clinical development project deliverables and...


  • New York, New York, United States Lifelancer Full time

    About the JobWe are seeking a highly skilled Biostatistics Director to lead statistical activities supporting clinical trials. This role will contribute to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting clinical trial data.ResponsibilitiesProvide statistical input to study...


  • New York, New York, United States Weill Cornell Medical College Full time

    Weill Cornell Medical College is a world-renowned institution dedicated to advancing medical knowledge and improving human health. As a Research Nurse Administrator Lead, you will play a critical role in supporting our research mission by overseeing the management of clinical trials and ensuring compliance with regulatory requirements.This position requires...


  • New York, New York, United States Princeton IT Services Full time

    Job DescriptionEstimated Salary: $200,000 - $300,000 per year, depending on experience.Location: Remote with occasional travel to clinical research sites.Job Type: Full-time Contract.About the Role:This Senior Medical Director position plays a critical role in ensuring that clinical trials are conducted in accordance with company SOPs, client directives,...


  • New York, New York, United States Formation Bio Full time

    About Formation BioWe are a tech and AI driven pharma company that is revolutionizing the industry with radically more efficient drug development. Our advancements in AI and drug discovery have created more candidate drugs than the industry can progress due to the high cost and time of clinical trials. To overcome this development bottleneck, we have built...


  • New York, New York, United States Everest Clinical Research Services Inc. Full time

    About the RoleWe are seeking an experienced Biostatistician to lead our team in delivering high-quality statistical services for clinical trials. As a Senior Biostatistician, you will play a key role in resolving day-to-day work-related issues, improving efficiency and productivity, and achieving quality and on-time delivery of...


  • New York, New York, United States Mount Sinai Hospital Full time

    About the RoleAt Mount Sinai Hospital, we are seeking an experienced Clinical Research Director to join our team. As a key member of our clinical trials department, you will be responsible for overseeing the implementation and conduct of clinical trials with investigational anti-cancer agents at our hospital sites.Key ResponsibilitiesCollaborate with medical...


  • New York, New York, United States Formation Bio Full time

    About Formation BioFormation Bio is a technology-driven pharmaceutical company that prioritizes efficient drug development. By leveraging AI and innovative approaches, we address the challenges associated with clinical trials and aim to bring new treatments to patients faster and more efficiently.The RoleWe are seeking an experienced Clinical Operations...


  • New York, New York, United States Formation Bio Full time

    About Formation BioAt Formation Bio, we're revolutionizing the pharmaceutical industry by leveraging AI and technology to accelerate drug development. Our mission is to bring new treatments to patients faster and more efficiently.The RoleWe're seeking a seasoned Senior Manager of Clinical Trials to lead our clinical monitoring efforts from study design...


  • New York, New York, United States Memorial Sloan-Kettering Cancer Center Full time

    Role OverviewClinical trials are a vital part of cancer treatment and research. As a Clinical Trials Nurse at Memorial Sloan Kettering Cancer Center, you will play a crucial role in facilitating the accrual of patients to clinical trials and coordinating patient care activities. You will work closely with the research team to provide direct nursing care,...


  • New York, New York, United States Roivant Sciences Full time

    Job Requirements:Bachelor's Degree in a scientific discipline; advanced degree preferred15+ years of clinical operations management experience, including trial leadership experienceExperience managing CROs and key clinical vendors requiredExperience developing clinical study protocols in conjunction with a study team requiredTrack record leading clinical...


  • New York, New York, United States Memorial Sloan Full time

    Job SummaryAs a Clinical Trials Nurse at Memorial Sloan Kettering Cancer Center, you will play a vital role in providing compassionate, evidence-based nursing care to Oncology patients and families living with cancer. You will work within a Nurse-Physician based Ambulatory Care Practice Model, facilitating accrual of appropriate patients to clinical trials,...


  • New York, New York, United States Northwell Health Full time

    About the RoleThe successful candidate will have a strong background in nursing and experience in clinical trials. You will work closely with the Principal Investigator (PI) to determine patient eligibility for clinical trials and ensure that all consent processes are performed and documented in compliance with applicable regulations.


  • New York, New York, United States NYU Grossman School of Medicine Full time

    Nursing Opportunities at NYU Grossman School of MedicineWe are dedicated to providing exceptional patient care and advancing medical research. As a Clinical Research Nurse II, you will work collaboratively with our team to support the safe, high-quality, and compliant conduct of oncology clinical research. This position involves prioritizing and advocating...


  • New York, New York, United States Northwell Health Full time

    Job SummaryWe are seeking a highly motivated Clinical Trials Coordinator - Surgery to join our research team. The successful candidate will play a critical role in the coordination and conduct of clinical trials, ensuring the integrity and quality of research studies.Key Responsibilities:Assist in research project planning and coordination.Collaborate with...


  • New York, New York, United States Lifelancer Full time

    About This RoleWe are seeking a highly experienced Clinical Development Director to lead our radiopharmaceuticals portfolio. As a key member of our team, you will be responsible for designing and executing clinical trials that drive innovation in the field of oncology.Job ResponsibilitiesDesign and execute clinical development plans for nominated drug...


  • New York, New York, United States NYU Langone Health Full time

    About NYU Langone HealthAs a world-class academic medical center, NYU Grossman School of Medicine is committed to improving the human condition through medical education, scientific research, and direct patient care. Our institution is dedicated to advancing knowledge in various fields, including medicine, nursing, and healthcare administration.Job...


  • New York, New York, United States BioSpace, Inc. Full time

    Job DescriptionWe are seeking a Principal Data Scientist to join our team at Recursion, a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. As a Principal Data Scientist, you will play a key role in supporting clinical trial planning and contextualizing observed efficacy of experimental arms in trials...