Associate Director, Clinical Research Scientist

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

The Role

This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.

This position is hybrid, and can be filled in HQ, Copenhagen, Denmark, Utrecht in The Netherlands or Princeton, NJ, US.


Responsibilities

  • Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds 
  • Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
  • Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s)
  • Contributes in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities). 
  • Lead the development of medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
  • Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
  • Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation, DMC, Steering Committee, Safety)
  • Participate in the development and review of study plans and serve as a liaison to project teams and CROs
  • Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
  • Provide input for the development of publications in coordination with Scientific Communications
  • Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted 

Requirements
Moreover, you meet the following professional requirements:

  • PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
  • Minimum of 8 years of experience in clinical research with at least 4 or more years of drug development experience   
  • Prior oncology/hematology drug development experience is a plus  
  • Proven skills from working in a project oriented matrixed team environment 
  • Excellent oral, written and interpersonal (communication) skills  
  • Ability to travel, as needed

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

  • Clinical Research Scientist

    6 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role This position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy.   Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist as indicated for ongoing clinical trial-related activities to provide high-quality and timely...

  • Clinical Research Associate Specialist

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU Clinical Trials Centre: A Career in Clinical ResearchThe HKU-CTC is a leading clinical trials management platform, established under the LKS Faculty of Medicine. We are dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.We offer long-term development opportunities to...

  • Clinical Research Associate

    2 maanden geleden

    Utrecht, Nederland Panda Voltijd

    For a leading company within drug development, laboratory and lifecycle services we are looking for a Clinical Research Associate (CRA). You will and play a vital role in delivering life-changing therapies to patients worldwide. As part of our team, you’ll have the opportunity to contribute to groundbreaking clinical trials across more than 100 countries,...

  • Senior Clinical Data Scientist: Lead Evidence Generation

    2 dagen geleden

    Utrecht, Utrecht, Nederland Danone Voltijd

    OverviewDanone, a leading global food company, is seeking an experienced Senior Clinical Data Scientist to join its Research & Innovation Center in Utrecht, Netherlands.

  • Clinical Research Associate

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    OverviewThe HKU is seeking a highly skilled Clinical Research Associate to join its research team in the School of Nursing.Salary and BenefitsA highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits.Job DescriptionThe appointee will work under the research team led by Dr...

  • Clinical Research Associate

    6 maanden geleden

    Utrecht, Nederland HKU Voltijd

    Clinical Research Associate (at the rank/grade of Technical Officer/Research Assistant I/II) in the Clinical Trials Centre (Ref: 524163) The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine and dedicated to managing and facilitating international-standard clinical trials on...

  • Research Scientist

    3 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU seeks a highly skilled Research Scientist in the field of neuromuscular disorders. As a Post-doctoral Fellow, you will play a key role in advancing our understanding of these complex conditions.The successful candidate will possess a Ph.D. or MD (higher doctorate) degree and a proven track record of research excellence. Experience in studying induced...

  • Research Scientist for Virology Laboratories

    1 maand geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU invites applications for a Research Scientist position in the Division of Public Health Laboratory Sciences. The successful candidate will be responsible for working in BSL-2 and BSL-2+ environments, operating manual and automatic nucleic acid extraction platforms, and conducting RT-PCR tests.The ideal candidate should have a Master's degree in...

  • Research Associate in Immunology and Tumor Cell Biology

    3 weken geleden

    Utrecht, Utrecht, Nederland CheckMark Labrecruitment Voltijd

    Job OverviewA leading biotechnology company is seeking a highly motivated Research Associate to join their team of experts in antibody drug discovery. The successful candidate will work closely with Scientists and Research Associates to explore new frontiers in the field.

  • Associate Director, Translational Medicine

    6 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role The Associate Director, Translational Medicine (TM) is a member of the TM team, which is embedded in the global Translational Research & Precision Medicine Department. The TM team focuses on preclinical and clinical translational research to advance the clinical development of innovative and differentiated antibody therapeutics for the treatment of...

  • Senior Research Scientist Position

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    We are seeking a highly skilled and experienced Senior Research Scientist to join our team at the School of Public Health in HKU.The successful candidate will have a Master's degree in biological sciences, medical sciences or related disciplines, with at least 5 years' working experience in virology laboratories.Key responsibilities include:Processing...

  • Senior Research Scientist

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU is seeking a highly motivated and experienced Senior Research Scientist to join its team in the Department of Microbiology, School of Clinical Medicine.The appointee will assist in research projects, perform laboratory routines, and maintain thorough laboratory bookkeeping. The successful candidate should have a strong background in Immunology/Cancer...

  • Senior Clinical Research Coordinator

    3 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Job Description:We are seeking a highly motivated and detail-oriented Senior Clinical Research Coordinator to join our team at HKU. The successful candidate will have the opportunity to work on exciting clinical research projects related to acute & chronic pain.About the Role:The appointee will assist the Principal Investigator in coordinating ongoing...

  • Senior Research Associate in Ethnic Minority Mental Health

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU: Senior Research Associate in Ethnic Minority Mental HealthWe are seeking a highly skilled and experienced Senior Research Associate to join our team at the Department of Psychiatry, School of Clinical Medicine.The appointee will participate in a 2-year pilot project aiming to evaluate the effectiveness of mental health counselling for ethnic minorities...

  • Scientific Research Associate, Biochemistry Expert

    3 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    The RoleWe are seeking a highly motivated and detail-oriented Scientific Research Associate to join our Antibody Research Materials department at Genmab. As a key member of our team, you will be responsible for managing the inventory and distributing research materials to various groups within the company.This role is part of our Protein Sample Management...

  • Clinical Research Associate

    3 weken geleden

    Utrecht, Utrecht, Nederland PRA Voltijd

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team in investigator site management. As a key member of our clinical operations group, you will be responsible for managing sites and investigators participating in studies.About the RoleThis role involves:Becoming familiar with ICON's SOPs/WPs, ICH GCP guidelines,...

  • Postdoctoral Research Scientist

    3 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    The University of Hong Kong invites applications for a Postdoctoral Research Scientist position in the Division of Public Health Laboratory Sciences.Located in the School of Public Health, this role offers a highly competitive salary commensurate with qualifications and experience, with annual leave and medical benefits included. The appointment will attract...

  • Clinical Trials Research Assistant

    1 maand geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU-CTC is a leading clinical trials management platform established under the LKS Faculty of Medicine, dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies. With a focus on promoting healthcare advancement through laboratory research, we are seeking a talented individual to...

  • Senior Health Data Scientist

    1 maand geleden

    Utrecht, Utrecht, Nederland Danone Voltijd

    Transforming Nutrition with Data-Driven Insights We are seeking a Senior Health Data Scientist to join our team at the Danone Nutricia Research & Innovation (R&I) Center in Utrecht, the Netherlands. As a key member of our cross-functional team, you will play a pivotal role in driving innovation and shaping the future of nutritional products through...

  • Senior Research Scientist

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    HKU Department of Chemistry is seeking a talented Senior Research Scientist to join Professor Hongjie Dai's research lab.The ideal candidate should possess a Ph.D. degree in chemistry, materials science, or a related field, with at least 2 years' postdoctoral experience. A strong publication record and excellent administrative work skills are required.We...