Research & Development Inc., a member of Johnson & Johnson's Family of
Companies, is recruiting for an Associate Director, Clinical Scientist -
Oncology, Experimental Medicine Early Development (eMED), preferably located in
Spring House, PA or Raritan, NJ.
the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters
most is helping people live full and healthy lives. We focus on treating,
curing and preventing some of the most devastating and complex diseases of our
time. And we pursue the most promising science, wherever it might be found.
Research & Development, LLC discovers and develops innovative medical solutions
to address important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.JanssenRnD.com for more information.
are Janssen. Our mission drives us. Our patients inspire us. We collaborate
with the world for the health of everyone in it.
on a diverse company culture, celebrating the uniqueness of our employees and
committed to inclusion. Proud to be an equal opportunity employer.
Clinical Scientist, Associate Director for Oncology Early Clinical Trials is
recruited to work in the Oncology Therapeutic Area Experimental Medicine Early
Development (eMED) group on novel anti-cancer compounds in early clinical
development. This position will report directly to the eMED Logistics &
Operations Leader and indirectly to the Early Development Clinical Leader.
Clinical Scientist has the following essential job functions:
within the cross-functional Early Development Clinical Team to plan, execute
and oversee patient-oriented early phase clinical trials.
closely with the Study Responsible Physician (SRP) and the ELO Leader in eMED
in the execution of oncology ED clinical trials.
as the Study Leader or Co-Leader for early phase clinical trials working in
close collaboration with the SRP.
study start-up activities including site selection, study budgets, timelines,
study conduct, clinical supplies, and to manage study close out activities.
the efficient collection and review of safety, efficacy, PK/PD, and
proof-of-concept data for early phase clinical trials while maintaining
adherence to Good Clinical Practice (GCP) guidelines.
closely with other key support areas including Global Clinical Operations,
Translational Research, Medical Writing, Regulatory Affairs, Project
Management, Biostatistics & Programing, and Clinical Pharmacology, and
other allied support functions.
operational leadership for early trials by working directly with local site
monitors and with the broader Global Clinical Operations group for larger early
scientific leadership internal for the conduct and interpretation of early
phase trials and externally in academic collaborations and scientific presentations
and publications directly related to trial outcomes.
Clinical Scientist, Associate Director will be responsible for:
protocol synopses, full protocols, informed consent documents, and will help
design Case Report Forms (CRFs) and other data collection tools.
will work hand in hand with the ELO Leader to ensure the efficient initiation
of early phase clinical trials and will provide input to the Statistical
Analysis Plan, the Data Management Plan, and the Safety Management Plan.
position will review the scope of work for central labs, central ECG and other
vendors, and will oversee the study start up process including budgets and
contracts, compliance with country/site regulations and SOPs.
Clinical Scientist will assist in site selection, and will lead investigator
meetings and site initiation visits. For ongoing clinical trials, this
individual will review all incoming clinical data in real time including
patient screening results, PK/PD data, adverse events and other study endpoints
and will perform medical review activities in collaboration with the SRP.
serving as Study Leader, this position will be responsible for the timely
delivery of clinical study milestones including study starts, database locks,
and topline results. Operational duties may include ensuring compliance with
Good Clinical Practice guidelines and working directly with local trial
managers and site monitor for smaller trials, or with the broader Global
Clinical Operations group to execute early phase clinical studies.
responsibilities will include internal activities such as interpreting clinical
endpoints for topline results, preparing Clinical Study Reports, and
participating in Disease Area Stronghold and Compound Development Team
scientific collaborations will include interacting directly with academic
investigators, coordinating clinical presentations at scientific meetings, and
facilitating scientific publications in a timely manner.
minimum of a Bachelor's Degree is
required, and Advanced degree (such as a Master’s degree, Ph.D. or Pharm. D ,
etc) is preferred.
minimum of 5 or more years of industry experience, in the areas of oncology
drug development, early phase clinical trials, and clinical operations is
knowledge of basic and translational research with an understanding of
applications to cancer drug development are required.
to the highest personal and ethical standards with a commitment to
patient-centered clinical research required.
position is located in Spring House, PA or Raritan, NJ and may require travel
up to 15% of the time.
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID