Clinical Research Director

4 weeks ago

Étreux, Hauts-de-France, United States Denali Health Full time

Job Summary:

Denali Health is seeking a dedicated and experienced Principal Investigator (PI) to lead and manage clinical research studies within our organization. The PI will be responsible for ensuring the integrity, safety, and success of clinical trials by overseeing all aspects of study design, execution, and compliance. The ideal Principal Investigator will have a strong background in clinical research, a commitment to upholding the highest ethical standards, and a passion for advancing medical science.

Key Responsibilities:

Pre-Study Responsibilities:

  • Protocol & Feasibility Review: Assess protocol and internal capabilities, provide feedback to the sponsor, and attend key meetings.
  • Regulatory Documentation: Sign off on essential study start-up documents.
  • Study Initiation & Communication: Participate in study initiation meetings to fully understand study requirements.
  • Subject Interaction & Screening: Explain the study to participants, obtain informed consent, assist in screening, and approve subjects for enrollment.

During/Post Study Responsibilities:

  • Study Conduct & Subject Management: Perform physical exams, manage adverse events, review study data, and collaborate with sponsors on safety data.
  • Safety Reporting & Documentation: Submit reports for Serious Adverse Events (SAEs), review and finalize Case Report Forms (CRFs), and monitor subject safety throughout the study.
  • Case Report Forms & On-Site Reviews: Review and sign CRFs, and assist in on-site reviews, providing expert insights.

Additional Responsibilities:

  • Network Development: Support business development and maintain a network of physician specialists.
  • Sponsor Interaction: Represent Denali Health at sponsor meetings and medical conferences.
  • Training & SOP Development: Assist in developing Standard Operating Procedures (SOPs), train staff, and ensure clinical safety preparedness at the site.

Qualifications:

Education:

  • MD or DO degree required. A PhD, in a related field may be considered.
  • Board certification in a relevant medical specialty is preferred.

Experience:

  • Minimum of 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
  • Proficiency in more than 1 language preferred.

Skills & Competencies:

  • Strong leadership and team management skills.
  • Excellent communication and interpersonal skills.
  • In-depth knowledge of GCP, FDA regulations, and IRB processes.
  • Ability to work collaboratively with multidisciplinary teams.
  • Detail orientation, and ability to multi-task as needed.

Key Benefits of the Opportunity:

Flexible Work Arrangements:

  • Conduct research within your own private practice or at our facilities, offering you the flexibility to choose the most convenient location.

Adaptable Scheduling:

  • Commitment typically requires 5-10 hours per week per study. Many study-related activities can be completed in a single day, with options for additional scheduling flexibility.

Compensation:

  • Negotiable.

Why Denali Health?

At Denali Health, we are committed to accelerating therapeutic innovations by breaking the bottlenecks in research and bridging the gap from bench to market. We promote an inclusive environment that fosters independence & career growth. We value integrity, innovation, and excellence in clinical research.

We are an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

  • Associate Director of Translational Research

    4 weeks ago

    Étreux, Hauts-de-France, United States Tempus AI Inc. Full time

    Job Title: Associate Director, Translational ResearchTempus AI Inc. is seeking a highly skilled Associate Director to lead our Translational Research team. As a key member of our Real-World Data Science organization, you will be responsible for designing and implementing research studies, analyzing data, and providing actionable insights to guide discovery...

  • Director of Inflammatory Bowel Disease Research

    5 days ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time

    Job DescriptionJob Title: Director of Inflammatory Bowel Disease ResearchTakeda Pharmaceuticals is seeking a highly experienced Director of Inflammatory Bowel Disease Research to join our team.Develop and lead internal and external partnered research from new target identification through early clinical proof-of-concept.Recruit and retain a world-class,...

  • Director of Investment Research

    1 month ago

    Étreux, Hauts-de-France, United States Wellington Management Company, LLP Full time

    About UsWellington Management is a leading investment management company that offers comprehensive investment solutions to institutional clients worldwide. Our investment platform is comprised of over 500 investment professionals across six investment functions, with a global presence in the Americas, EMEA, and APAC regions.The RoleWe are seeking a Director...

  • Clinical Research Liaison and Community Outreach Specialist

    4 days ago

    Étreux, Hauts-de-France, United States Boston Medical Center Full time

    About the Role:Boston Medical Center is seeking a highly skilled Clinical Research Liaison and Community Outreach Specialist to join our team. As a key member of our Clinical Research Network, you will play a vital role in developing and implementing recruitment strategies to engage diverse community members in clinical research studies.Key...

  • Director of Infectious Diseases Research and Development

    4 weeks ago

    Étreux, Hauts-de-France, United States Boston University Full time

    Job Title: Director of Infectious Diseases Research and DevelopmentJob Summary: Boston University is seeking a highly experienced Director of Infectious Diseases Research and Development to join our team at CARB-X. As a key member of our organization, you will be responsible for managing our portfolio of prevention products, including vaccines, live...

  • Research Director of Inflammatory and Autoimmune Diseases

    7 days ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the RoleThe Takeda Pharmaceutical company is seeking a highly skilled and experienced Director of Inflammatory Bowel Disease Research to join our innovative Gastrointestinal and Inflammation (GI2) Drug Discovery Unit.This is an exceptional opportunity for a talented scientist to lead internal and external partnered research from target identification...

  • Clinical Research Specialist

    4 weeks ago

    Étreux, Hauts-de-France, United States Massachusetts General Hospital Full time

    Job SummaryThe Clinical Research Specialist will play a key role in the success of our research program by coordinating and overseeing the implementation of recruitment and other operations activities for multiple, concurrent clinical research studies/trials. This includes strategizing with staff to resolve problems, ensuring uniform application of...

  • Clinical Research Manager

    4 weeks ago

    Étreux, Hauts-de-France, United States Dana-Farber Cancer Institute Full time

    Clinical Research Manager Job DescriptionJob Summary: We are seeking a highly skilled Clinical Research Manager to join our team at Dana-Farber Cancer Institute. The successful candidate will be responsible for managing the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator...

  • Director, Investment Research Leader

    1 month ago

    Étreux, Hauts-de-France, United States Wellington Management Company, LLP Full time

    About UsWellington Management Company, LLP is a leading investment management firm that offers comprehensive investment solutions to institutional clients worldwide. Our investment platform is comprised of over 500 investment professionals across six investment functions, managing approximately $1 trillion in assets across the capital structure.About the...

  • Clinical Research Nurse

    7 days ago

    Étreux, Hauts-de-France, United States Boston Medical Center (BMC) Full time

    Job OverviewBoston Medical Center (BMC) is seeking a skilled Clinical Research Nurse to join our team in the Cancer Research department.Key ResponsibilitiesAssist principal investigators with protocol development and review.Collaborate with quality assurance teams to develop protocol-specific materials.Recruit and register patients for clinical trials,...

  • Clinical Research Coordinator

    4 weeks ago

    Étreux, Hauts-de-France, United States Brigham & Women's Hospital(BWH) Full time

    Job Summary:The Brigham and Women's Hospital (BWH) is seeking a highly motivated and organized Clinical Research Coordinator to join our team in the Men's Health, Aging and Metabolism Clinical Research Unit. As a Clinical Research Coordinator, you will provide support to Senior Research Coordinators and participate in all aspects of the day-to-day management...

  • Biologics Research Director

    5 days ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time

    About the Role:Takeda is seeking an exceptional Biologics Research Director to lead our team of scientists in the discovery and development of innovative biologics therapies. As a key member of our Global Biologics organization, you will be responsible for leading biologics programs from early discovery through candidate nomination and selection.With a...

  • Clinical Research Nurse

    1 month ago

    Étreux, Hauts-de-France, United States Mass General Brigham Full time

    About the RoleMass General Brigham is seeking a highly skilled Clinical Research Nurse to join our team. As a key member of our research team, you will be responsible for implementing and conducting clinical trials in various disease programs.Key ResponsibilitiesCollaborate with physician investigators to establish processes and workflows for protocol...

  • Senior Research Director for Inflammatory Diseases

    4 weeks ago

    Étreux, Hauts-de-France, United States Takeda Pharmaceutical Company Ltd Full time

    About the Role:Takeda Pharmaceutical Company Ltd is seeking a highly skilled and experienced Director of Inflammatory Bowel Disease Research to join our team. As a key member of our Gastrointestinal and Inflammation (GI2) Drug Discovery Unit, you will be responsible for driving internal and external partnered research from new target identification to early...

  • Clinical Research Coordinator

    4 weeks ago

    Étreux, Hauts-de-France, United States Brigham and Women's Hospital Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Brigham and Women's Hospital. The successful candidate will be responsible for ensuring the smooth operation of clinical trials, from protocol development to study close-out.Key ResponsibilitiesCoordinate trial activities, including site...

  • Clinical Research Coordinator

    4 weeks ago

    Étreux, Hauts-de-France, United States Leaman Life Sciences Full time

    We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Leaman Life Sciences. In this role, you will be responsible for managing administration and logistic tasks in relation to trial feasibility, start-up through to close out of clinical trials, sample management, and site liaison.As a Clinical Research...

  • Associate Director of Research and Sponsored Programs

    4 weeks ago

    Étreux, Hauts-de-France, United States Simmons University Full time

    Job SummaryThe Associate Director of Research and Sponsored Programs is a key position within the Center for Faculty Excellence (CFE) at Simmons University. Reporting to the Executive Director, this role oversees federal grant submission processes, provides support to faculty in locating sources of funding and preparing persuasive grant proposals, ensures...

  • Clinical Research Nurse

    4 weeks ago

    Étreux, Hauts-de-France, United States Mass General Brigham Full time

    Job SummaryMass General Brigham is seeking a highly skilled Clinical Research Nurse to join our team. As a key member of our research team, you will be responsible for assisting in the implementation of Cardiology research protocols.This is a full-time position that requires excellent communication and organizational skills, as well as the ability to work...

  • Clinical Research Coordinator

    4 weeks ago

    Étreux, Hauts-de-France, United States Brigham & Women's Hospital(BWH) Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Brigham & Women's Hospital (BWH). The successful candidate will be responsible for ensuring the smooth operation of clinical trials, from initiation to completion, in compliance with regulatory requirements and sponsor standards.Key...

  • Clinical Research Associate

    4 weeks ago

    Étreux, Hauts-de-France, United States Brigham and Women's Hospital Full time

    Job Summary:The Clinical Research Associate will be responsible for ensuring the assigned site study staff conduct the study in compliance with the currently approved protocol/amendment(s) and trial operations manual. This includes performing on-site visits, such as Qualification, Site Initiation, Interim Monitoring and Study Close-out Visits, in accordance...