Associate Director, Clinical Project Scientist - Oncology, Experimental Medicine & Early Development (eMED)
Location:
Raritan , New Jersey
Posted:
April 02, 2017
Reference:
7191170123/2-en-us

Janssen 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.

 

At 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.

 

Janssen 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.

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

The 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.

 

The Clinical Scientist has the following essential job functions:

 
  • Work within the cross-functional Early Development Clinical Team to plan, execute and oversee patient-oriented early phase clinical trials.
  • Collaborate closely with the Study Responsible Physician (SRP) and the ELO Leader in eMED in the execution of oncology ED clinical trials.
  • Function as the Study Leader or Co-Leader for early phase clinical trials working in close collaboration with the SRP.
  • Oversee study start-up activities including site selection, study budgets, timelines, study conduct, clinical supplies, and to manage study close out activities.
  • Ensure 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.
  • Work 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.
  • Provide operational leadership for early trials by working directly with local site monitors and with the broader Global Clinical Operations group for larger early phase trials.
  • Provide 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.
 

The Clinical Scientist, Associate Director will be responsible for:

  • Writing protocol synopses, full protocols, informed consent documents, and will help design Case Report Forms (CRFs) and other data collection tools.
  • He/She 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.
  • The 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.
  • The 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.
  • When 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.
  • Scientific 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 activities.
  • External scientific collaborations will include interacting directly with academic investigators, coordinating clinical presentations at scientific meetings, and facilitating scientific publications in a timely manner.


Qualifications

  • A 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.
  • A minimum of 5 or more years of industry experience, in the areas of oncology drug development, early phase clinical trials, and clinical operations is required.
  • Significant knowledge of basic and translational research with an understanding of applications to cancer drug development are required.
  • Adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research required.
  • The position is located in Spring House, PA or Raritan, NJ and may require travel up to 15% of the time. 



 


Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research non-MD
Requisition ID
7191170123

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